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This randomized, double-blind, flexible-dose, placebo-controlled, parallel group study is designed to evaluate Aptensio XR® compared to placebo in preschool age children with ADHD. Male and female children ages 4 years, 0 months to 5 years, 8 months with a diagnosis of ADHD (combined, inattentive or hyperactive/impulsive) will be enrolled.
There will be 6 phases in this study: a screening phase of up to 4 weeks, which will include washout if applicable, an enrollment & parent training phase lasting 2-4 weeks, an eligibility phase of up to 2 weeks to determine eligibility for the open-label phase, a 6-week open-label dose titration phase, a 2 week double-blind phase for Aptensio XR® responders, and a two-week follow-up call after study completion or early discontinuation to assess for ongoing adverse events and concomitant medications.
Up to 150 subjects will be enrolled in this trial to allow for subjects who improve significantly during the behavior training phase and drop-outs. Once 74 subjects have completed the double-blind phase, no additional subjects will be enrolled in the trial. Subjects who are already enrolled at that time will be allowed to complete the trial.
The primary objective of this study is to establish that an optimal dose of Aptensio XR® will result in a significant reduction in ADHD symptoms compared with placebo in children ages 4 to under 6 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aptensio XR | Experimental | Optimized dose of Aptensio XR (10, 15, 20, 30 or 40 mg Aptensio XR) |
|
| Placebo comparator | Placebo Comparator | Placebo capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aptensio XR | Drug | Optimized dose of Aptensio XR (10, 15, 20, 30 or 40 mg) administered orally, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Total Score Change From End of Open Label Phase (Baseline) to End of Double Blind. | ADHD-RS-IV is 18-item scale incorporates each of the ADHD symptoms listed in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) regardless of assigned subtype. Scoring was based on the universally accepted symptom severity as recommended in the DSM-IV-TR manual on a 4-point scale: 0 = never or rarely, 1 = sometimes, 2 = often, and 3 = very often. The total score is the sum of the scores for all 18 items and could range from 0 (no impairment) to 54 (maximal impairment) for each administration per subject. Higher score means higher frequency and severity of symptoms. Trained clinicians administered the questionnaire to parents. The ADHD-RS-IV Preschool Version was used to determine eligibility, optimal dosing and the efficacy of double blind treatment. | 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98. |
| Measure | Description | Time Frame |
|---|---|---|
| Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Hyperactivity-Impulsivity Subscale Score Change From End of Open Label Phase (Baseline) to End of Double Blind. | This 18-item scale incorporates each of the ADHD symptoms listed in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) regardless of assigned subtype. Scoring was based on the universally accepted symptom severity as recommended in the DSM-IV-TR manual on a 4-point scale: 0=never or rarely, 1=sometimes, 2=often, and 3=very often. The Hyperactivity-Impulsivity even items. The Hyperactivity-Impulsivity subscale score was the sum of the scores for the 9 even items and could range from 0 (no impairment) to 27 (maximal impairment) for each administration per subject. Higher score means higher frequency and severity of symptoms. Trained clinicians administered the questionnaire to parents. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Childress, MD | Center for Psychiatry And Behavioral Medicine Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Psychiatry and Behavioral Medicine Inc. | Las Vegas | Nevada | 89128 | United States | ||
| Duke University Medical Center |
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| Label | URL |
|---|---|
| Related Info | View source |
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The Enrolled Population consisted of all subjects who were not screen failures. Of these enrolled subjects, 119 entered the Open-label Treatment Phase and 90 were randomized to the Double-blind Treatment Phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-label Treatment Phase | 6-week open-label treatment phase. Aptensio XR capsules administered orally, once daily. |
| FG001 | Aptensio XR | Optimized dose of Aptensio XR administered orally, once daily. |
| FG002 | Placebo Comparator | Placebo capsules administered orally, once daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Open-label Treatment Phase |
| |||||||||||||
| Double-blind Treatment Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aptensio XR | Optimized dose of Aptensio XR administered orally, once daily. |
| BG001 | Placebo Comparator | Placebo capsules administered orally, once daily. |
| 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 | Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Total Score Change From End of Open Label Phase (Baseline) to End of Double Blind. | ADHD-RS-IV is 18-item scale incorporates each of the ADHD symptoms listed in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) regardless of assigned subtype. Scoring was based on the universally accepted symptom severity as recommended in the DSM-IV-TR manual on a 4-point scale: 0 = never or rarely, 1 = sometimes, 2 = often, and 3 = very often. The total score is the sum of the scores for all 18 items and could range from 0 (no impairment) to 54 (maximal impairment) for each administration per subject. Higher score means higher frequency and severity of symptoms. Trained clinicians administered the questionnaire to parents. The ADHD-RS-IV Preschool Version was used to determine eligibility, optimal dosing and the efficacy of double blind treatment. | The Efficacy Evaluable (ITT-E) population consists of all subjects in the intent-to-treat (ITT) population who completed ADHD-RS-IV assessments at the end of the open-label treatment phase (i.e., baseline) and had at least one post-baseline ADHD-RS-IV assessment. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98. |
The AE-reporting period for this trial began at the Screening visit and ended with the 2-week follow-up phone call at end of study, up to 20 weeks.
AEs were summarized for any exposure to Aptensio XR during the open-label treatment phase, and for each treatment (i.e., Aptensio XR or placebo) in the double-blind phase.
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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 | Open-label Treatment Phase | 6-week open-label treatment phase. Aptensio XR capsules administered orally, once daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Campylobacter infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Inder Chaudhary | Rhodes Pharmaceuticals L.P. | 401-262-9272 | inder.chaudhary@rhodespharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2018 | Sep 22, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Titration Study
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Blinded active capsules looked identical to the same strength placebo capsules
| Placebo | Drug | Placebo capsules |
|
|
| 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98. |
| Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Inattention Subscale Score Change From End of Open Label Phase (Baseline) to End of Double Blind. | This 18-item scale incorporates each of the ADHD symptoms listed in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) regardless of assigned subtype. Scoring was based on the universally accepted symptom severity as recommended in the DSM-IV-TR manual on a 4-point scale: 0=never or rarely, 1=sometimes, 2=often, and 3=very often. The Inattention subscales were based upon the sum of the odd items. The Inattention subscale score was the sum of the scores for the 9 odd items and could range from 0 (no impairment) to 27 (maximal impairment) for each administration per subject. Higher score means higher frequency and severity of symptoms. Trained clinicians administered the questionnaire to parents. | 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98. |
| Summary of Clinical Global Impression Scale of Severity (CGI-S) Score From End of Open Label Phase (Baseline) to End of Double Blind. | The scale provides a global rating of illness severity during the trial. The subject is rated relative to the clinician's past experience with other subjects who have the same diagnosis. The CGI-S scale is 1 question and rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill subjects). A lower value a better the outcome. | 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98. |
| Clinical Global Impression Scale of Improvement (CGI-I) Score at End of Double Blind Phase Relative to End of Open Label Phase (Baseline). | The scale provides a global rating of illness improvement during the trial. The subject is rated relative to the clinician's past experience with other subjects who have the same diagnosis. The CGI-I scale is 1 question, and rates improvement compared with a baseline visit using a 7-point scale. The range of responses are from 1 (very much improved) through 7 (very much worse). A lower value is a better the outcome. | 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98. |
| Conners Early Childhood Behavior - Parent (Short) (EC BEH-P(S)) Change in T-score From End of Open Label Phase (Baseline) to End of Double Blind | Conners EC BEH-P(S) is an assessment tool used to obtain a parent's observations about his/her child's behavior. This tool is designed to assess a range of behavioral, emotional, & social issues in young children. The tool consists of 47 items, responses to which are summarized in 6 behavioral scales & 2 validity scales. Items on Conners assessment are rated on a Likert scale ranging from 0-3. The ratings were converted to raw item scores. Raw item scores were grouped, standardized, and/or compared to lookup tables for interpretation. Assessments were presented as T-scores: item raw scores for a given scale are added together; this raw sum is compared to age- and gender-matched normative data and converted to a T-score. Higher scores indicate higher concerns. T-score is a standard score with a mean of 50 and standard deviation of 10. Note that Conners assessments do not use T-scores greater than 90; raw scores that produce extremely high T-scores are reported as ''T-score >= 90." | 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98. |
| Durham |
| North Carolina |
| 27705 |
| United States |
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Secondary | Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Hyperactivity-Impulsivity Subscale Score Change From End of Open Label Phase (Baseline) to End of Double Blind. | This 18-item scale incorporates each of the ADHD symptoms listed in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) regardless of assigned subtype. Scoring was based on the universally accepted symptom severity as recommended in the DSM-IV-TR manual on a 4-point scale: 0=never or rarely, 1=sometimes, 2=often, and 3=very often. The Hyperactivity-Impulsivity even items. The Hyperactivity-Impulsivity subscale score was the sum of the scores for the 9 even items and could range from 0 (no impairment) to 27 (maximal impairment) for each administration per subject. Higher score means higher frequency and severity of symptoms. Trained clinicians administered the questionnaire to parents. | The Efficacy Evaluable (ITT-E) population consists of all subjects in the intent-to-treat (ITT) population who completed ADHD-RS-IV assessments at the end of the open-label treatment phase (i.e., baseline) and had at least one post-baseline ADHD-RS-IV assessment. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98. |
|
|
|
| Secondary | Attention Deficit Hyperactivity Disorder Rating Scale - 4th Edition (ADHD-RS-IV) Preschool Version Inattention Subscale Score Change From End of Open Label Phase (Baseline) to End of Double Blind. | This 18-item scale incorporates each of the ADHD symptoms listed in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) regardless of assigned subtype. Scoring was based on the universally accepted symptom severity as recommended in the DSM-IV-TR manual on a 4-point scale: 0=never or rarely, 1=sometimes, 2=often, and 3=very often. The Inattention subscales were based upon the sum of the odd items. The Inattention subscale score was the sum of the scores for the 9 odd items and could range from 0 (no impairment) to 27 (maximal impairment) for each administration per subject. Higher score means higher frequency and severity of symptoms. Trained clinicians administered the questionnaire to parents. | The Efficacy Evaluable (ITT-E) population consists of all subjects in the intent-to-treat (ITT) population who completed ADHD-RS-IV assessments at the end of the open-label treatment phase (i.e., baseline) and had at least one post-baseline ADHD-RS-IV assessment. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98. |
|
|
|
| Secondary | Summary of Clinical Global Impression Scale of Severity (CGI-S) Score From End of Open Label Phase (Baseline) to End of Double Blind. | The scale provides a global rating of illness severity during the trial. The subject is rated relative to the clinician's past experience with other subjects who have the same diagnosis. The CGI-S scale is 1 question and rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill subjects). A lower value a better the outcome. | The Efficacy Evaluable (ITT-E) population consists of all subjects in the intent-to-treat (ITT) population who completed ADHD-RS-IV assessments at the end of the open-label treatment phase (i.e., baseline) and had at least one post-baseline ADHD-RS-IV assessment. | Posted | Count of Participants | Participants | 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98. |
|
|
|
| Secondary | Clinical Global Impression Scale of Improvement (CGI-I) Score at End of Double Blind Phase Relative to End of Open Label Phase (Baseline). | The scale provides a global rating of illness improvement during the trial. The subject is rated relative to the clinician's past experience with other subjects who have the same diagnosis. The CGI-I scale is 1 question, and rates improvement compared with a baseline visit using a 7-point scale. The range of responses are from 1 (very much improved) through 7 (very much worse). A lower value is a better the outcome. | The Efficacy Evaluable (ITT-E) population consists of all subjects in the intent-to-treat (ITT) population who completed ADHD-RS-IV assessments at the end of the open-label treatment phase (i.e., baseline) and had at least one post-baseline ADHD-RS-IV assessment. | Posted | Count of Participants | Participants | 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98. |
|
|
|
| Secondary | Conners Early Childhood Behavior - Parent (Short) (EC BEH-P(S)) Change in T-score From End of Open Label Phase (Baseline) to End of Double Blind | Conners EC BEH-P(S) is an assessment tool used to obtain a parent's observations about his/her child's behavior. This tool is designed to assess a range of behavioral, emotional, & social issues in young children. The tool consists of 47 items, responses to which are summarized in 6 behavioral scales & 2 validity scales. Items on Conners assessment are rated on a Likert scale ranging from 0-3. The ratings were converted to raw item scores. Raw item scores were grouped, standardized, and/or compared to lookup tables for interpretation. Assessments were presented as T-scores: item raw scores for a given scale are added together; this raw sum is compared to age- and gender-matched normative data and converted to a T-score. Higher scores indicate higher concerns. T-score is a standard score with a mean of 50 and standard deviation of 10. Note that Conners assessments do not use T-scores greater than 90; raw scores that produce extremely high T-scores are reported as ''T-score >= 90." | The Efficacy Evaluable (ITT-E) population consists of all subjects in the intent-to-treat (ITT) population who completed ADHD-RS-IV assessments at the end of the open-label treatment phase (i.e., baseline) and had at least one post-baseline ADHD-RS-IV assessment. | Posted | Mean | Standard Deviation | T-score | 2 weeks: End of open label phase (Baseline) at study day 84 to end of double blind treatment at study day 98. |
|
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|
| 0 |
| 119 |
| 1 |
| 119 |
| 82 |
| 119 |
| EG001 | Aptensio XR | Optimized dose of Aptensio XR administered orally, once daily. | 0 | 40 | 0 | 40 | 6 | 40 |
| EG002 | Placebo Comparator | Placebo capsules administered orally, once daily. | 0 | 50 | 0 | 50 | 2 | 50 |
| Irritability | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Emotional Disorder | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Affect lability | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Initial insomnia | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
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| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 3 = Mildly ill |
|
| 4 = Moderately ill |
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| 5 = Markedly ill |
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| 6 = Severely ill |
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| 7 = Among the most extremely ill subjects |
|
| End of Double-blind Treatment |
|
| 3 = Minimally improved |
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| 4 = No change |
|
| 5 = Minimally worse |
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| 6 = Much worse |
|
| 7 = Very much worse |
|
| Social Functioning / Atypical Behaviors |
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| Anxiety |
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| Mood and Affect |
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| Physical Symptoms |
|