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| ID | Type | Description | Link |
|---|---|---|---|
| B4Z-US-LYEI | Other Identifier | Eli Lilly and Company | |
| 2019-000419-98 | EudraCT Number |
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This study will evaluate the effects of atomoxetine on brain activation during attention and reading tasks via functional Magnetic Resonance Imaging (fMRI) in participants ages 10 to 16 years old with ADHD and comorbid dyslexia
This is a randomized, placebo-controlled, double-blind, single site study that uses an fMRI measurement to assess brain activation during attention and reading tasks and the effects of atomoxetine in reducing symptoms of ADHD in participants with ADHD and comorbid dyslexia. Similar assessments are performed in two additional groups of participants with ADHD only and dyslexia only to determine to what extent symptomatic change in the comorbid ADHD & dyslexia is achieved independently by atomoxetine effects on either condition. A healthy control group of non-ADHD, non-dyslexia subjects (20) will be included to monitor practice effects & effects of treatment that may be interpreted as normal maturation. The healthy control group will not be treated with any study medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atomoxetine | Experimental | Atomoxetine will be administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks (study period II). Participants who complete the study period II will be re-randomized in the study period III of 16-week duration to assess maintenance of benefit following discontinuation of treatment with atomoxetine. Participants assigned to atomoxetine during the study period II will be re-randomized to either atomoxetine or placebo whereas participants previously assigned to placebo will receive atomoxetine. |
|
| Placebo | Placebo Comparator | Placebo will be packaged in the same way as active comparator to enforce double-blind study design |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atomoxetine | Drug | Atomoxetine will be administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) BOLD response (Blood-oxygen-level-dependent response) | Baseline, 16 Weeks |
| Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks) | Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks) | Baseline, 16 Weeks |
| Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks) | Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) BOLD response (Blood-oxygen-level-dependent response) | Baseline, 16 Weeks |
| Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks) | Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks) | Baseline, 16 Weeks |
| Change From Baseline to Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS) Total Score in the ADHD or ADHD + Dyslexia | The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a restricted maximum likelihood (REML)-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Endpoint in Basic Reading Skills Cluster WJ III in Participants With Dyslexia Alone | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. Basic Reading Skills is an aggregate measure of sight vocabulary, phonics, and structural analysis. It is a combination of Test 1, Letter-Word Identification, which measures the participant's word identification skills, and Test 13, Word Attack, which measures skill in applying phonic and structural analysis skills to the pronunciation of unfamiliar printed words. It is the average (arithmetic mean) of the tests 1 and 13. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Participants were randomized to either atomoxetine or placebo during study period II. Placebo participants were then assigned to atomoxetine in study period III. Atomoxetine participants were re-randomized to atomoxetine or placebo in study period III. Participants assigned to the healthy control group did not receive any study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atomoxetine | Atomoxetine (ATX) 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) was administered orally once daily in the morning for 16 weeks, during study period II, (SP II). All eligible participants who received atomoxetine during study period II and completed that period were re-randomized to atomoxetine or placebo in study period III (SP III). |
| FG001 | Placebo | Placebo (PLA) was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III. |
| FG002 | ATX/ATX | These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day. |
| FG003 | ATX/PLA | These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day. |
| FG004 | PLA/ATX | These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day. |
| FG005 | Healthy Participants | Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for Attention Deficit Hyperactivity Disorder (ADHD) or dyslexia. They received no treatment during the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study Period II (16-Weeks) |
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| Study Period III (16-Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Atomoxetine | Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) BOLD response (Blood-oxygen-level-dependent response) | All participants who received study drug, had Dyslexia Alone and had fMRI data. | Posted | Mean | Standard Deviation | Change-from-baseline (BOLD response) | Baseline, 16 Weeks |
|
Baseline Up To 34 Weeks
The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atomoxetine | Atomoxetine 1.0 to 1.4 mg/kg was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D004410 | Dyslexia |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D007806 | Language Disorders |
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| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Placebo | Drug | oral, daily, for 16 weeks |
|
| Baseline, 16 weeks |
| Change From Baseline to Endpoint in Woodcock Johnson Tests of Achievement (WJ III) Word Attack Total Score in Participants With Dyslexia Alone | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores which is a greater range of standard scores. Test 13, Word Attack, measures skill in applying phonic, structural analysis to the pronunciation of unfamiliar printed words. Each individual test scores range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. Least Square (LS) Mean was analyzed using last observation carried forward (LOCF), fixed-effects analysis of covariate (ANCOVA) models with terms for treatment, gender, baseline, age, treatment*baseline. | Baseline, 16 Weeks |
| Baseline, 16 Weeks |
| Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia | The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the attention-deficit disorder (ADD). 0-39 equate to, "ADD possible but not likely". 40-54 equate to, "ADD probable but not certain". 55-120 equate to, "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | Baseline, 16 Weeks |
| Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | Baseline, 16 Weeks |
| Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | Baseline, 16 Weeks |
| Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | Baseline, 16 Weeks |
| Change From Baseline to Endpoint in Comprehensive Test of Phonological Processing (CTOPP) Composite Scores in Participants With Dyslexia Alone | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | Baseline, 16 weeks |
| Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD + Dyslexia | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | Baseline, 16 weeks |
| Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD Alone | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | Baseline, 16 weeks |
| Change From Baseline to Endpoint in Gray Oral Reading Tests-4 (GORT-4) in Participants With Dyslexia Alone | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models of with terms for treatment, gender, baseline, age, treatment*baseline. | Baseline, 16 weeks |
| Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment*baseline. | Baseline, 16 weeks |
| Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment*baseline. | Baseline, 16 weeks |
| Change From Baseline to Endpoint Test of Word Reading Efficiency (TOWRE) Total Score in Participants With Dyslexia Alone | The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | Baseline, 16 Weeks |
| Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia | The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | Baseline, 16 Weeks |
| Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | Baseline, 16 Weeks |
| Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | Baseline, 16 Weeks |
| Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | Baseline, 16 Weeks |
| Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone | The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | Baseline, 16 Weeks |
| Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone | The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | Baseline, 16 Weeks |
| Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for gender, baseline score, and age. | Baseline, 32 Weeks |
| Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction. | Baseline, 32 Weeks |
| Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction. | Baseline, 32 Weeks |
| Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | Baseline, 32 Weeks |
| Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | Baseline, 32 Weeks |
| Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | Baseline, 32 Weeks |
| Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | Baseline, 32 Weeks |
| Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | Baseline, 32 Weeks |
| Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | Baseline, 32 Weeks |
| Change From Baseline to Endpoint in Participants in TOWRE Total Score With Dyslexia Alone | The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | Baseline, 32 Weeks |
| Change From Baseline to Endpoint in Participants in TOWRE Total Score With ADHD or ADHD + Dyslexia | The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | Baseline, 32 Weeks |
| Change From Baseline to Endpoint in Participants in WMTB-C With Dyslexia Alone | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | Baseline, 32 Weeks |
| Change From Baseline to Endpoint in Participants in WMTB-C With ADHD + Dyslexia | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | Baseline, 32 Weeks |
| Change From Baseline to Endpoint in Participants in WMTB-C With ADHD Alone | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | Baseline, 32 Weeks |
| Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone | The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age. | Baseline, 32 Weeks |
| Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia | The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age. | Baseline, 32 Weeks |
| Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With Dyslexia Alone | The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age. | Baseline, 32 Weeks |
| Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD +Dyslexia | The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age. | Baseline, 32 Weeks |
| Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Pseudoword Rhyming, Semantic-category) | Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Pseudoword Rhyming, Semantic-category) | From Week 16, Up to Week 32 |
| Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Tasks) | Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Tasks) | From Week 16, Up to 32 Weeks |
| Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks) | Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks) | From Week 16, Up to Week 32 |
| Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks) | Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks) | From Week 16, Up to Week 32 |
| Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction. | From Week 16, Up to 32 Weeks |
| Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction. | From Week 16, Up to Week 32 |
| Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction. | From Week 16, Up to Week 32 |
| Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | From Week 16, Up to Week 32 |
| Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | From Week 16, Up to Week 32 |
| Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | From Week 16, Up to Week 32 |
| Change From Baseline to Endpoint TOWRE Total Score in Participants With Dyslexia Alone | The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | From Week 16, Up to Week 32 |
| Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia | The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | From Week 16, Up to Week 32 |
| Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | From Week 16, Up to Week 32 |
| Change From Baseline to Endpoint in GORT-4 in Participants With ADHD+ Dyslexia | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | From Week 16, Up to Week 32 |
| Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | From Week 16, Up to Week 32 |
| Change From Baseline to Endpoint in WMTB-C in Participants With Dyslexia Alone | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | From Week 16, Up to Week 32 |
| Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | From Week 16, Up to Week 32 |
| Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | From Week 16, Up to Week 32 |
| Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone | The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | From Week 16, Up to Week 32 |
| Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia | The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | From Week 16, Up to Week 32 |
| Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone | The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | From Week 16, Up to Week 32 |
| Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD + Dyslexia | The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | From Week 16, Up to Week 32 |
| The Number of Participants With Treatment Emergent Adverse Events (TEAE) in Participants With Dyslexia | The number of participants who experienced one or more treatment emergent adverse events (TEAEs) and who had Dyslexia A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. | 16 Weeks |
| The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia. | The number of participants who experienced one or more TEAEs and who had ADHD and ADHD+Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. | 16 Weeks |
| The Number of Participants With TEAE in Participants With Dyslexia | The number of participants with at least one TEAE and had Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. | From 16 Weeks Up to Week 32 |
| The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia. | The number of participants who experienced one or more TEAEs with ADHD and ADHD + Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. | From Week 16 Up to Week 32 |
| Number of Participants With Adverse Events | Number of participants who had at least one adverse event. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. | 32 Weeks |
| Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. | Baseline, 16 Weeks |
| Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. | Baseline, 16 Weeks |
| Change From Baseline to Endpoint in GORT-4 in Healthy Participants | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. | Baseline, 16 weeks |
| Change From Baseline to Endpoint TOWRE Total Score in Healthy Participants | The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analyses which includes diagnostic group, visit, and diagnostic group-by-visit interaction. | Baseline, 16 Weeks |
| Change From Baseline to Endpoint in WMTB-C in Healthy Participants | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). | Baseline, 16 Weeks |
| Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants | The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes the effects of diagnostic group, visit, and diagnostic group-by-visit interaction. | Baseline, 16 Weeks |
| Change From Baseline to Endpoint in ADHDRS-IV Total Score in Healthy Participants | The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes diagnostic group, visit, and diagnostic group-by-visit interaction. | Baseline, 16 Weeks |
| Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. | Baseline, 32 Weeks |
| Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. | Baseline, 32 weeks |
| Change From Baseline to Endpoint in GORT-4 in Healthy Participants | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. | Baseline, 32 Weeks |
| Change From Baseline to Endpoint in TOWRE Total Score in Healthy Participants | The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes diagnostic group, visit, and diagnostic group-by-visit interaction. | Baseline, 32 Weeks |
| Change From Baseline to Endpoint in WMTB-C in Healthy Participants | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). | Baseline, 32 Weeks |
| Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants | The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction. | Baseline, 32 Weeks |
| Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Healthy Participants | The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction. | Baseline, 32 Weeks |
| Protocol Violation |
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| Withdrawal by Subject |
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| Physician Decision |
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| Parent/Caregiver Decision |
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| Lost to Follow-up |
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| COMPLETED |
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| NOT COMPLETED |
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Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III. |
| BG002 | Healthy Participants | Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 |
| Placebo |
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III. |
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| Primary | Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks) | Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks) | Stroop Tasks data were not collected. | Posted | Baseline, 16 Weeks |
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| Primary | Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks) | Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) BOLD response (Blood-oxygen-level-dependent response) | All participants who received study drug, had ADHD or ADHD + Dyslexia and had fMRI data. | Posted | Mean | Standard Deviation | Change-from-baseline (BOLD response) | Baseline, 16 Weeks |
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| Primary | Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks) | Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks) | Stroop Tasks data were not collected. | Posted | Baseline, 16 Weeks |
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| Primary | Change From Baseline to Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS) Total Score in the ADHD or ADHD + Dyslexia | The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a restricted maximum likelihood (REML)-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 weeks |
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| Primary | Change From Baseline to Endpoint in Woodcock Johnson Tests of Achievement (WJ III) Word Attack Total Score in Participants With Dyslexia Alone | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores which is a greater range of standard scores. Test 13, Word Attack, measures skill in applying phonic, structural analysis to the pronunciation of unfamiliar printed words. Each individual test scores range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. Least Square (LS) Mean was analyzed using last observation carried forward (LOCF), fixed-effects analysis of covariate (ANCOVA) models with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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| Secondary | Change From Baseline to Endpoint in Basic Reading Skills Cluster WJ III in Participants With Dyslexia Alone | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. Basic Reading Skills is an aggregate measure of sight vocabulary, phonics, and structural analysis. It is a combination of Test 1, Letter-Word Identification, which measures the participant's word identification skills, and Test 13, Word Attack, which measures skill in applying phonic and structural analysis skills to the pronunciation of unfamiliar printed words. It is the average (arithmetic mean) of the tests 1 and 13. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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| Secondary | Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia | The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the attention-deficit disorder (ADD). 0-39 equate to, "ADD possible but not likely". 40-54 equate to, "ADD probable but not certain". 55-120 equate to, "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline BADD-A measurements. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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| Secondary | Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who had a WJ III baseline and post-baseline measurement. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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| Secondary | Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who had a baseline and post-baseline WJ III measurement. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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| Secondary | Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who had a baseline and post-baseline WJ III measurement. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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| Secondary | Change From Baseline to Endpoint in Comprehensive Test of Phonological Processing (CTOPP) Composite Scores in Participants With Dyslexia Alone | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 16 weeks |
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| Secondary | Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD + Dyslexia | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 16 weeks |
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| Secondary | Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD Alone | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 16 weeks |
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| Secondary | Change From Baseline to Endpoint in Gray Oral Reading Tests-4 (GORT-4) in Participants With Dyslexia Alone | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models of with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 weeks |
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| Secondary | Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment*baseline. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 weeks |
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| Secondary | Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment*baseline. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 weeks |
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| Secondary | Change From Baseline to Endpoint Test of Word Reading Efficiency (TOWRE) Total Score in Participants With Dyslexia Alone | The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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| Secondary | Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia | The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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| Secondary | Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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| Secondary | Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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| Secondary | Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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| Secondary | Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone | The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline BADD-A measurements. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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| Secondary | Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone | The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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| Secondary | Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for gender, baseline score, and age. | All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WJ III measurements. No participants by design were on placebo for both study periods II and III. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 32 Weeks |
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| Secondary | Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction. | All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WJ III measurements. No participants by design were on placebo for both study periods II and III. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 32 Weeks |
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| Secondary | Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction. | All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WJ III measurements. No participants by design were on placebo for both study periods II and III. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 32 Weeks |
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| Secondary | Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 32 Weeks |
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| Secondary | Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 32 Weeks |
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| Secondary | Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 32 Weeks |
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| Secondary | Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 32 Weeks |
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| Secondary | Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 32 Weeks |
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| Secondary | Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 32 Weeks |
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| Secondary | Change From Baseline to Endpoint in Participants in TOWRE Total Score With Dyslexia Alone | The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline TOWRE measurements. No participants by design were on placebo for both study periods II and III. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 32 Weeks |
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| Secondary | Change From Baseline to Endpoint in Participants in TOWRE Total Score With ADHD or ADHD + Dyslexia | The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline TOWRE measurements. No participants by design were on placebo for both study periods II and III. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 32 Weeks |
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| Secondary | Change From Baseline to Endpoint in Participants in WMTB-C With Dyslexia Alone | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WMTB-C measurements. No participants by design were on placebo for both study periods II and III. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 32 Weeks |
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| Secondary | Change From Baseline to Endpoint in Participants in WMTB-C With ADHD + Dyslexia | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who had received atomoxetine in both phases and had evaluable baseline and post baseline WTMB-C measurements.No participants by design were on placebo for both study periods II and III. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 32 Weeks |
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| Secondary | Change From Baseline to Endpoint in Participants in WMTB-C With ADHD Alone | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who had received atomoxetine in both phases and had evaluable baseline and post baseline WTMB-C measurements.No participants by design were on placebo for both study periods II and III. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 32 Weeks |
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| Secondary | Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone | The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age. | All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline BADD-A measurements. No participants by design were on placebo for both study periods II and III. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 32 Weeks |
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| Secondary | Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia | The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age. | All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline BADD-A measurements. No participants by design were on placebo for both study periods II and III. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 32 Weeks |
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| Secondary | Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With Dyslexia Alone | The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age. | All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements. No participants by design were on placebo for both study periods II and III. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 32 Weeks |
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| Secondary | Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD +Dyslexia | The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age. | All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements. No participants by design were on placebo for both study periods II and III. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 32 Weeks |
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| Secondary | Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Pseudoword Rhyming, Semantic-category) | Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Pseudoword Rhyming, Semantic-category) | For this outcome measure, there were no data collected beyond 16 weeks. | Posted | No | From Week 16, Up to Week 32 |
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| Secondary | Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Tasks) | Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Tasks) | Stroop Tasks data were not collected. | Posted | No | From Week 16, Up to 32 Weeks |
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| Secondary | Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks) | Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks) | For this outcome measure, there were no data collected beyond 16 weeks. | Posted | No | From Week 16, Up to Week 32 |
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| Secondary | Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks) | Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks) | Stroop Tasks data were not collected. | Posted | No | From Week 16, Up to Week 32 |
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| Secondary | Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction. | All participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given. | Posted | Least Squares Mean | Standard Error | units on a scale | From Week 16, Up to 32 Weeks |
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| Secondary | Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction. | All participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given. | Posted | Least Squares Mean | Standard Error | units on a scale | From Week 16, Up to Week 32 |
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| Secondary | Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline score, age, and baseline score by treatment interaction. | All participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given. | Posted | Least Squares Mean | Standard Error | units on a scale | From Week 16, Up to Week 32 |
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| Secondary | Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given. | Posted | Least Squares Mean | Standard Error | units on a scale | From Week 16, Up to Week 32 |
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| Secondary | Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given. | Posted | Least Squares Mean | Standard Error | units on a scale | From Week 16, Up to Week 32 |
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| Secondary | Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given. | Posted | Least Squares Mean | Standard Error | units on a scale | From Week 16, Up to Week 32 |
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| Secondary | Change From Baseline to Endpoint TOWRE Total Score in Participants With Dyslexia Alone | The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | All participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given. | Posted | Least Squares Mean | Standard Error | units on a scale | From Week 16, Up to Week 32 |
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| Secondary | Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia | The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | All participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given. | Posted | Least Squares Mean | Standard Error | units on a scale | From Week 16, Up to Week 32 |
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| Secondary | Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given. | Posted | Least Squares Mean | Standard Error | units on a scale | From Week 16, Up to Week 32 |
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| Secondary | Change From Baseline to Endpoint in GORT-4 in Participants With ADHD+ Dyslexia | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given. | Posted | Least Squares Mean | Standard Error | units on a scale | From Week 16, Up to Week 32 |
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| Secondary | Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given. | Posted | Least Squares Mean | Standard Error | units on a scale | From Week 16, Up to Week 32 |
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| Secondary | Change From Baseline to Endpoint in WMTB-C in Participants With Dyslexia Alone | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who received at least one dose of study drug and had baseline and post baseline WMTB-C measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given. | Posted | Least Squares Mean | Standard Error | units on a scale | From Week 16, Up to Week 32 |
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| Secondary | Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who received at least one dose of study drug and had baseline and post baseline WMTB-C measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given. | Posted | Least Squares Mean | Standard Error | units on a scale | From Week 16, Up to Week 32 |
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| Secondary | Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment*baseline. | All randomized participants who received at least one dose of study drug and had baseline and post baseline WMTB-C measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given. | Posted | Least Squares Mean | Standard Error | units on a scale | From Week 16, Up to Week 32 |
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| Secondary | Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone | The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | All randomized participants who received at least one dose of study drug and had baseline and post baseline BADD-A measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given. | Posted | Least Squares Mean | Standard Error | units on a scale | From Week 16, Up to Week 32 |
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| Secondary | Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia | The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | All randomized participants who received at least one dose of study drug and had baseline and post baseline BADD-A measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given. | Posted | Least Squares Mean | Standard Error | units on a scale | From Week 16, Up to Week 32 |
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|
|
| Secondary | Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone | The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | All randomized participants who received at least one dose of study drug and had baseline and post baseline ADHDRS-IV measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given. | Posted | Least Squares Mean | Standard Error | units on a scale | From Week 16, Up to Week 32 |
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|
|
| Secondary | Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD + Dyslexia | The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | All randomized participants who received at least one dose of study drug and had baseline and post baseline ADHDRS-IV measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given. | Posted | Least Squares Mean | Standard Error | units on a scale | From Week 16, Up to Week 32 |
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| Secondary | The Number of Participants With Treatment Emergent Adverse Events (TEAE) in Participants With Dyslexia | The number of participants who experienced one or more treatment emergent adverse events (TEAEs) and who had Dyslexia A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. | All randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | 16 Weeks |
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|
| Secondary | The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia. | The number of participants who experienced one or more TEAEs and who had ADHD and ADHD+Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. | All randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | 16 Weeks |
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|
|
| Secondary | The Number of Participants With TEAE in Participants With Dyslexia | The number of participants with at least one TEAE and had Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. | All randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | From 16 Weeks Up to Week 32 |
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|
| Secondary | The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia. | The number of participants who experienced one or more TEAEs with ADHD and ADHD + Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. | All randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | From Week 16 Up to Week 32 |
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|
|
| Secondary | Number of Participants With Adverse Events | Number of participants who had at least one adverse event. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. | All randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | 32 Weeks |
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|
| Secondary | Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. | All healthy participants who had evaluable baseline and post baseline WJ III measurements. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 16 Weeks |
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| Secondary | Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. | All healthy participants who had evaluable baseline and post baseline CTOPP measurements. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 16 Weeks |
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|
| Secondary | Change From Baseline to Endpoint in GORT-4 in Healthy Participants | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. | All healthy participants who had evaluable baseline and post baseline GORT-4 measurements. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 16 weeks |
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| Secondary | Change From Baseline to Endpoint TOWRE Total Score in Healthy Participants | The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analyses which includes diagnostic group, visit, and diagnostic group-by-visit interaction. | All healthy participants who had evaluable baseline and post baseline TOWRE measurements. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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|
|
| Secondary | Change From Baseline to Endpoint in WMTB-C in Healthy Participants | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). | All healthy participants who had evaluable baseline and post baseline WMTB-C measurements. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 16 Weeks |
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|
|
| Secondary | Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants | The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes the effects of diagnostic group, visit, and diagnostic group-by-visit interaction. | All participants who had evaluable baseline and post baseline BADD-A measurements. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
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|
|
| Secondary | Change From Baseline to Endpoint in ADHDRS-IV Total Score in Healthy Participants | The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes diagnostic group, visit, and diagnostic group-by-visit interaction. | All healthy participants who had evaluable baseline and post baseline ADHDRS-IV measurements. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 16 Weeks |
|
|
|
| Secondary | Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. | All healthy participants who had baseline and post-baseline WJ III measurements. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 32 Weeks |
|
|
|
| Secondary | Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better and lower scores are poor. | All healthy participants who had evaluable baseline and post baseline CTOPP measurements. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 32 weeks |
|
|
|
| Secondary | Change From Baseline to Endpoint in GORT-4 in Healthy Participants | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. Lower scores indicate poor reading skills. | All healthy participants who had evaluable baseline and post baseline GORT-4 measurements. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 32 Weeks |
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|
|
| Secondary | Change From Baseline to Endpoint in TOWRE Total Score in Healthy Participants | The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes diagnostic group, visit, and diagnostic group-by-visit interaction. | All healthy participants who had evaluable baseline and post baseline TOWRE measurements. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 32 Weeks |
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|
| Secondary | Change From Baseline to Endpoint in WMTB-C in Healthy Participants | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better, Lower scores are poor) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). | All healthy participants who had evaluable baseline and post baseline WMTB-C measurements. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 32 Weeks |
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|
| Secondary | Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants | The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction. | All healthy participants who had evaluable baseline and post baseline BADD-A measurements. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 32 Weeks |
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|
| Secondary | Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Healthy Participants | The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a REML-based, MMRM analysis which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction. | All healthy participants who had evaluable baseline and post baseline ADHDRS-IV measurements. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 32 Weeks |
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|
|
| 0 |
| 45 |
| 35 |
| 45 |
| EG001 | Placebo | Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III. | 0 | 44 | 31 | 44 |
| EG002 | ATX/ATX | These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day. | 0 | 18 | 8 | 18 |
| EG003 | ATX/PLA | These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day. | 0 | 18 | 8 | 18 |
| EG004 | PLA/ATX | These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day. | 0 | 35 | 25 | 35 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Therapeutic response unexpected | General disorders | MedDRA 19.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
|
| Monocyte count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Psychomotor hyperactivity | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Abnormal behaviour | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
|
| Attention deficit/hyperactivity disorder | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Emotional disorder | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Initial insomnia | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Mood swings | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Nightmare | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Personality change | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 19.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
|
| Educational problem | Social circumstances | MedDRA 19.0 | Systematic Assessment |
|
Not provided
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000067559 | Specific Learning Disorder |
| D007859 | Learning Disabilities |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| ADHD+Dyslexia, Semantic-category: Left Interior Temporal Gyrus |
|
|
| ADHD+Dyslexia, Semantic-category: Left Medial Temporal Gyrus |
|
|
| ADHD+Dyslexia, Semantic-category: Left Temporo-parietal Region |
|
|
| ADHD+Dyslexia, Semantic-category: Right Inferior Frontal Gyrus |
|
|
| ADHD+Dyslexia, Semantic-category: Right Interior Temporal Gyrus |
|
|
| ADHD+Dyslexia, Semantic-category: Right Medial Temporal Gyrus |
|
|
| ADHD+Dyslexia, Semantic-category: Right Temporo-parietal Region |
|
|
| ADHD+Dyslexia, Pseudoword Rhyming: Left Inferior Frontal Gyrus |
|
|
| ADHD+Dyslexia, Pseudoword Rhyming: Left Interior Temporal Gyrus |
|
|
| ADHD+Dyslexia, Pseudoword Rhyming: Left Medial Temporal Gyrus |
|
|
| ADHD+Dyslexia, Pseudoword Rhyming: Left Temporo-parietal Region |
|
|
| ADHD+Dyslexia, Pseudoword Rhyming: Right Inferior Frontal Gyrus |
|
|
| ADHD+Dyslexia, Pseudoword Rhyming: Right Interior Temporal Gyrus |
|
|
| ADHD+Dyslexia, Pseudoword Rhyming: Right Medial Temporal Gyrus |
|
|
| ADHD+Dyslexia, Pseudoword Rhyming: Temporo-parietal Region |
|
|
| ADHD Only, Semantic-category: Left Inferior Frontal Gyrus |
|
|
| ADHD Only, Semantic-category: Left Interior Temporal Gyrus |
|
|
| ADHD Only, Semantic-category: Left Medial Temporal Gyrus |
|
|
| ADHD Only, Semantic-category: Left Temporo-parietal Region |
|
|
| ADHD Only, Semantic-category: Right Inferior Frontal Gyrus |
|
|
| ADHD Only, Semantic-category: Right Interior Temporal Gyrus |
|
|
| ADHD Only, Semantic-category: Right Medial Temporal Gyrus |
|
|
| ADHD Only, Semantic-category: Right Temporo-parietal Region |
|
|
| ADHD Only, Pseudoword Rhyming: Left Inferior Frontal Gyrus |
|
|
| ADHD Only, Pseudoword Rhyming: Left Interior Temporal Gyrus |
|
|
| ADHD Only, Pseudoword Rhyming: Left Medial Temporal Gyrus |
|
|
| ADHD Only, Pseudoword Rhyming: Left Temporo-parietal Region |
|
|
| ADHD Only, Pseudoword Rhyming: Right Inferior Frontal Gyrus |
|
|
| ADHD Only, Pseudoword Rhyming: Right Interior Temporal Gyrus |
|
|
| ADHD Only, Pseudoword Rhyming: Right Medial Temporal Gyrus |
|
|
| ADHD Only, Pseudoword Rhyming: Temporo-parietal Region |
|
|
| ADHD Alone |
|
|
| ADHD Alone |
|
|
| Reading Vocabulary Score |
|
| Reading Fluency Score |
|
| Reading Comprehension Score |
|
| Spelling Score |
|
| Spelling of Sounds Score |
|
| Basic Reading Skills Score |
|
| Passage Comprehension |
|
| Letter Word Identification |
|
| Word Attack Score |
|
| Reading Vocabulary |
|
| Spelling |
|
| Spelling of Sounds |
|
| Basic Reading Skills |
|
| Passage Comprehension Score |
|
| Letter Word Identification |
|
| Word Attack Score |
|
| Reading Vocabulary |
|
| Spelling |
|
| Spelling of Sounds |
|
| Basic Reading Skills |
|
| Passage Comprehension Score |
|
| Rapid Naming Score |
|
| Rapid Naming Score |
|
| Rapid Naming Score |
|
| Fluency |
|
| Reading Comprehension |
|
| Oral Reading Quotient |
|
| Fluency |
|
| Reading Comprehension |
|
| Oral Reading Quotient |
|
| Fluency |
|
| Reading Comprehension |
|
| Oral Reading Quotient |
|
| ADHD Alone |
|
|
| Word List Recall Score |
|
| Nonword List Recall Score |
|
| Block Recall Score |
|
| Mazes Memory Score |
|
| Listening Recall Score |
|
| Counting Recall Score |
|
| Backward Digit Recall Score |
|
| Word List Recall |
|
| NonWord |
|
| Block Recall |
|
| Mazes Memory Score |
|
| Listening Recall |
|
| Counting Recall |
|
| Backward Digit Recall |
|
| Word List Recall |
|
| NonWord |
|
| Block Recall |
|
| Mazes Memory Score |
|
| Listening Recall |
|
| Counting Recall |
|
| Backward Digit Recall |
|
| Title | Measurements |
|---|---|
|
| Spelling |
|
| Spelling of Sounds |
|
| Basic Reading Skills |
|
| Passage Comprehension Score |
|
| Word Attack Score |
|
| Reading Vocabulary Score |
|
| Title | Measurements |
|---|---|
|
| Reading Fluency |
|
| Reading Comprehension |
|
| Spelling |
|
| Spelling of Sounds |
|
| Basic Reading Skills |
|
| Passage Comprehension Score |
|
| Title | Measurements |
|---|---|
|
| Reading Fluency |
|
| Reading Comprehension |
|
| Spelling |
|
| Spelling of Sounds |
|
| Basic Reading Skills |
|
| Passage Comprehension Score |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Reading Comprehension |
|
| Oral Reading Quotient |
|
| Title | Measurements |
|---|---|
|
| Reading Comprehension |
|
| Oral Reading Quotient |
|
| Title | Measurements |
|---|---|
|
| Reading Comprehension |
|
| Oral Reading Quotient |
|
|
| Title | Measurements |
|---|---|
|
| Nonword List Recall Score |
|
| Block Recall Score |
|
| Mazes Memory Score |
|
| Listening Recall Score |
|
| Counting Recall Score |
|
| Backwards Digit Recall Score |
|
| Title | Measurements |
|---|---|
|
| Nonword List Recall Score |
|
| Block Recall Score |
|
| Mazes Memory Score |
|
| Listening Recall Score |
|
| Counting Recall Score |
|
| Backward Digit Recall Score |
|
| Title | Measurements |
|---|---|
|
| Nonword List Recall Score |
|
| Block Recall Score |
|
| Mazes Memory Score |
|
| Listening Recall Score |
|
| Counting Recall Score |
|
| Backward Digit Recall Score |
|
|
|
| Reading Fluency |
|
| Reading Comprehension |
|
| Spelling |
|
| Spelling of Sounds |
|
| Basic Reading Skills |
|
| Passage Comprehension Score |
|
| Reading Vocabulary Score |
|
| Reading Vocabulary Score |
|
| Reading Fluency |
|
| Reading Comprehension |
|
| Spelling |
|
| Spelling of Sounds |
|
| Basic Reading Skills |
|
| Passage Comprehension Score |
|
| Reading Vocabulary Score |
|
| Reading Fluency |
|
| Reading Comprehension |
|
| Spelling |
|
| Spelling of Sounds |
|
| Basic Reading Skills |
|
| Passage Comprehension Score |
|
| Rapid Naming Score |
|
| Rapid Naming Score |
|
| Rapid Naming Score |
|
| ADHD Alone |
|
|
| Fluency |
|
| Reading Comprehension |
|
| Oral Reading Quotient |
|
| Fluency |
|
| Reading Comprehension |
|
| Oral Reading Quotient |
|
| Fluency |
|
| Reading Comprehension |
|
| Oral Reading Quotient |
|
| Word List Recall Score |
|
| Nonword List Recall Score |
|
| Block Recall Score |
|
| Mazes Memory Score |
|
| Listening Recall Score |
|
| Counting Recall Score |
|
| Backward Digit Recall Score |
|
| Word List Recall Score |
|
| NonWord List Recall |
|
| Block Recall Score |
|
| Mazes Memory Score |
|
| Listening Recall Score |
|
| Counting Recall Score |
|
| Backward Recall Score |
|
| Word List Recall Score |
|
| NonWord List Recall |
|
| Block Recall Score |
|
| Mazes Memory Score |
|
| Listening Recall Score |
|
| Counting Recall Score |
|
| Backward Recall Score |
|
| ADHD Alone |
|
|
| ADHD alone |
|
|
| ADHD alone |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Reading Fluency |
|
| Reading Comprehension |
|
| Spelling |
|
| Spelling of Sounds |
|
| Basic Reading Skills |
|
| Passage Comprehension |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Reading Comprehension |
|
| Oral Reading Quotient |
|
| Title | Measurements |
|---|---|
|
| Nonword List Recall Score |
|
| Block Recall Score |
|
| Mazes Memory Score |
|
| Listening Recall Score |
|
| Counting Recall Score |
|
| Backward Digit Recall Score |
|
| Title | Measurements |
|---|---|
|
| Reading Comprehension |
|
| Reading Fluency |
|
| Spelling |
|
| Spelling of Sounds |
|
| Basic Reading Skills Score |
|
| Passage Comprehension |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Comprehension |
|
| Oral Reading Quotient |
|
| Title | Measurements |
|---|---|
|
| Nonword List Recall Score |
|
| Block Recall Score |
|
| Mazes Memory Score |
|
| Listening Recall Score |
|
| Counting Recall Score |
|
| Backwards Digit Recall Score |
|