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To evaluate the efficacy of LDX compared to placebo in adults with ADHD in the adult workplace environment (AWE) setting
This study has both an optimization and double-blind period
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX, SPD489) | Active Comparator |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDX | Drug | oral, 30, 50, or 70 mg once-daily for 4 weeks during dose optimization, and then for 1 week during each crossover during the adult workplace environment setting |
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| Measure | Description | Time Frame |
|---|---|---|
| Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase | The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance. | 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| PERMP Total Score by Timepoint in the Crossover Phase | The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance. | 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Study Centers, LLC | Little Rock | Arkansas | 72205 | United States | ||
| University of CA, Irvine Child Development Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20576091 | Result | Wigal T, Brams M, Gasior M, Gao J, Squires L, Giblin J; 316 Study Group. Randomized, double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: novel findings using a simulated adult workplace environment design. Behav Brain Funct. 2010 Jun 24;6:34. doi: 10.1186/1744-9081-6-34. | |
| 21566420 |
| Label | URL |
|---|---|
| FDA recall information | View source |
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The study consisted of a 4-week dose optimization phase (30, 50 or 70 mg SPD489 once-daily) and a 2-week crossover phase. Of the 142 subjects enrolled in the dose optimization phase, 15 discontinued prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | SPD489 First | Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg for 1 week during the first intervention and placebo is administered once-daily for 1 week in the second intervention. |
| FG001 | Placebo First |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Dose Optimization Period |
|
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| Placebo | Drug | Placebo administered once-daily for one week during the adult workplace environment setting |
|
| PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase | The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance. | 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7 |
| PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase | The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance. | 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7 |
| Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale With Prompts (ADHD-RS) Total Score at up to 28 Days in the Dose Optimization Phase | The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (ADHD-RS) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. | Baseline and 7, 14, 21 and 28 days |
| ADHD-RS With Prompts Total Score in the Crossover Phase | The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (ADHD-RS) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. | 7 days |
| Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase | CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) | Baseline |
| Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Dose Optimization Phase | CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. | 7, 14, 21 and 28 days |
| Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase | CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. | 7 days |
| Change From Baseline in the Brown Attention Deficit Disorder Scale (BADDS) Total Scores at 26 Days in the Dose Optimization Phase | The BADDS assessment consists of 40 items rated on a scale from 0 (never) to 3 (almost daily). The total score ranges from 0 to 120 with increasing scores indicating more severe impairment. | Baseline and 26 days |
| Level of Satisfaction With Study Treatment on Medication Satisfaction Questionnaire (MSQ) in the Dose Optimization Phase | MSQ is a survey rating the subject's level of satisfaction with the study treatment medication. | 26 days |
| Change From Baseline in Adult ADHD Impact Module (AIM-A) Question 1 Score at 26 Days in the Dose Optimization Phase | AIM-A is a quality of life instrument. Question 1 is 'On a scale of 1 to 10, how would you rate the overall quality of life right now?' It is rated on a scale of 1 (worst) to 10 (best). | Baseline and 26 days |
| Change From Baseline in AIM-A Question 4 Score at 26 Days in the Dose Optimization Phase | AIM-A is a quality of life instrument. Question 4 is 'How much do you agree with this statement: Over the past few weeks, I've had more good days than bad days?' This is rated on a scale of 1 (strongly agree) to 5 (strongly disagree). | Baseline and 26 days |
| Change From Baseline in Systolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase | Baseline and 7, 14, 21 and 28 days |
| Change From Baseline in Diastolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase | Baseline and 7, 14, 21 and 28 days |
| Change From Baseline in Pulse Rate at Up to 28 Days in the Dose Optimization Phase | Baseline and 7, 14, 21 and 28 days |
| Change From Baseline in Electrocardiogram Results (QTcF Interval) at 7 Days in the Crossover Phase | QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation. | Baseline and 7 days |
| Irvine |
| California |
| 92612 |
| United States |
| Vince & Associates Clinical Research | Overland Park | Kansas | 66212 | United States |
| Center for Psychiatry & Behavioral Medicine, Inc | Las Vegas | Nevada | 89128 | United States |
| Bayou City Research, LTD | Houston | Texas | 77007 | United States |
| Result |
| Brams M, Giblin J, Gasior M, Gao J, Wigal T. Effects of open-label lisdexamfetamine dimesylate on self-reported quality of life in adults with ADHD. Postgrad Med. 2011 May;123(3):99-108. doi: 10.3810/pgm.2011.05.2288. |
| 21973229 | Result | Brown TE, Brams M, Gasior M, Adeyi B, Babcock T, Dirks B, Scheckner B, Wigal T. Clinical utility of ADHD symptom thresholds to assess normalization of executive function with lisdexamfetamine dimesylate treatment in adults. Curr Med Res Opin. 2011;27 Suppl 2:23-33. doi: 10.1185/03007995.2011.605441. |
| 20861583 | Derived | Brown TE, Brams M, Gao J, Gasior M, Childress A. Open-label administration of lisdexamfetamine dimesylate improves executive function impairments and symptoms of attention-deficit/hyperactivity disorder in adults. Postgrad Med. 2010 Sep;122(5):7-17. doi: 10.3810/pgm.2010.09.2196. |
Placebo is administered once-daily for 1 week in the first intervention and Lisdexamfetamine Dimesylate (LDX, SPD489)is dosed once-daily at 30, 50 or 70 mg for 1 week during the second intervention. |
| COMPLETED |
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| NOT COMPLETED |
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| First Intervention (Crossover Period) |
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| Second Intervention (Crossover Period) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase | The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance. | Intent to Treat (ITT) population defined as all subjects who are randomized and have at least one post-dose primary efficacy assessment. | Posted | Least Squares Mean | Standard Error | Units on a scale | 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7 |
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| Secondary | PERMP Total Score by Timepoint in the Crossover Phase | The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance. | ITT | Posted | Least Squares Mean | Standard Error | Units on a scale | 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7 |
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| Secondary | PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase | The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance. | ITT | Posted | Least Squares Mean | Standard Error | Units on a scale | 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7 |
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| Secondary | PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase | The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance. | ITT | Posted | Least Squares Mean | Standard Error | Units on a scale | 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7 |
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| Secondary | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale With Prompts (ADHD-RS) Total Score at up to 28 Days in the Dose Optimization Phase | The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (ADHD-RS) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. | Enrolled Efficacy Population (EEP) defined as all subjects who have taken one dose of study medication in the Dose Optimization Phase and had one post-Baseline efficacy assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 7, 14, 21 and 28 days |
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| Secondary | ADHD-RS With Prompts Total Score in the Crossover Phase | The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (ADHD-RS) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. | ITT | Posted | Least Squares Mean | Standard Error | Units on a scale | 7 days |
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| Secondary | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase | CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) | EEP | Posted | Number | Participants | Baseline |
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| Secondary | Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Dose Optimization Phase | CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. | EEP | Posted | Number | Participants | 7, 14, 21 and 28 days |
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| Secondary | Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase | CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. | ITT | Posted | Number | Participants | 7 days |
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| Secondary | Change From Baseline in the Brown Attention Deficit Disorder Scale (BADDS) Total Scores at 26 Days in the Dose Optimization Phase | The BADDS assessment consists of 40 items rated on a scale from 0 (never) to 3 (almost daily). The total score ranges from 0 to 120 with increasing scores indicating more severe impairment. | EEP | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 26 days |
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| Secondary | Level of Satisfaction With Study Treatment on Medication Satisfaction Questionnaire (MSQ) in the Dose Optimization Phase | MSQ is a survey rating the subject's level of satisfaction with the study treatment medication. | EEP | Posted | Number | Participants | 26 days |
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| Secondary | Change From Baseline in Adult ADHD Impact Module (AIM-A) Question 1 Score at 26 Days in the Dose Optimization Phase | AIM-A is a quality of life instrument. Question 1 is 'On a scale of 1 to 10, how would you rate the overall quality of life right now?' It is rated on a scale of 1 (worst) to 10 (best). | EEP | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 26 days |
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| Secondary | Change From Baseline in AIM-A Question 4 Score at 26 Days in the Dose Optimization Phase | AIM-A is a quality of life instrument. Question 4 is 'How much do you agree with this statement: Over the past few weeks, I've had more good days than bad days?' This is rated on a scale of 1 (strongly agree) to 5 (strongly disagree). | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 26 days |
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| Secondary | Change From Baseline in Systolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase | Safety Population (SP) defined as all subjects who received at least one dose of study medication. | Posted | Mean | Standard Deviation | mmHg | Baseline and 7, 14, 21 and 28 days |
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| Secondary | Change From Baseline in Diastolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase | SP | Posted | Mean | Standard Deviation | mmHg | Baseline and 7, 14, 21 and 28 days |
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| Secondary | Change From Baseline in Pulse Rate at Up to 28 Days in the Dose Optimization Phase | SP | Posted | Mean | Standard Deviation | bpm | Baseline and 7, 14, 21 and 28 days |
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| Secondary | Change From Baseline in Electrocardiogram Results (QTcF Interval) at 7 Days in the Crossover Phase | QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation. | SP | Posted | Mean | Standard Deviation | msec | Baseline and 7 days |
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Safety Population defined as all subjects who received at least one dose of study medication. All 142 subjects received at least one dose of study medication during the dose optimization phase. In the crossover phase, 64 subjects received placebo in the first intervention and 53 in the second intervention for a total of 117 for placebo.
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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 | SPD489 | Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg for 1 week during the first intervention and placebo is administered once-daily for 1 week in the second intervention. | 0 | 142 | 113 | 142 | ||
| EG001 | Placebo | Placebo is administered once-daily for 1 week in the first intervention and Lisdexamfetamine Dimesylate (LDX, SPD489)is dosed once-daily at 30, 50 or 70 mg for 1 week during the second intervention. | 0 | 117 | 23 | 117 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders |
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| Nausea | Gastrointestinal disorders |
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| Feeling jittery | General disorders |
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| Irritability | General disorders |
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| Upper respiratory tract infection | Infections and infestations |
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| Decreased appetite | Metabolism and nutrition disorders |
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| Headache | Nervous system disorders |
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| Anxiety | Psychiatric disorders |
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| Insomnia | Psychiatric disorders |
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| Fatigue | General disorders |
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If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| 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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| Withdrawal by Subject |
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| Title | Denominators | Categories | ||||
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| Normal, not at all ill |
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| Borderline mentally ill |
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| Mildly ill |
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| Moderately ill |
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| Markedly ill |
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| Severely ill |
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| Among the most extremely ill subjects |
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| Title | Denominators | Categories |
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| Very satisfied |
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