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The primary objective of this study is to assess the time of onset of Vyvanse compared to placebo, in the analog classroom as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment scale in children (aged 6-12) diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vyvanse (lisdexamfetamine dimesylate) | Drug | Following completion of the open-label dose optimization period and successful titration to an optimal dose of Vyvanse™, subjects will take their optimized dose of Vyvanse™ (30, 50 or 70 mg/day). |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of Effect of Vyvanse | The onset of effect will be defined as the first assessment time showing statistical significance between Vyvanse and placebo as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Deportment scale. The degree of impairment is rated from 0 (normal) to 6 (maximal). | Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Effect of Vyvanse | Duration of effect will be defined as the first time point at which there is a non-significant difference between Vyvanse and placebo after a time point at which there is a significant difference between the two treatment groups as measured by SKAMP Deportment Scores. The degree of impairment is rated from 0 (normal) to 6 (maximal). | Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose. |
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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 | United States | |||
| Univ. of CA, Irvine Child Development Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19508731 | Result | Wigal SB, Kollins SH, Childress AC, Squires L; 311 Study Group. A 13-hour laboratory school study of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder. Child Adolesc Psychiatry Ment Health. 2009 Jun 9;3(1):17. doi: 10.1186/1753-2000-3-17. | |
| 21156071 | Result | Wigal SB, Kollins SH, Childress AC, Adeyi B. Efficacy and tolerability of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: sex and age effects and effect size across the day. Child Adolesc Psychiatry Ment Health. 2010 Dec 14;4:32. doi: 10.1186/1753-2000-4-32. |
| Label | URL |
|---|---|
| FDA Recall Information | View source |
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The study consisted of an open-label dose-optimization phase (4 weeks), followed by a randomized, placebo-controlled, 2-way crossover phase (1 week each).
129 subjects were enrolled for dose optimization phase, 12 discontinued, and 117 were randomized to the cross-over phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vyvanse First | Vyvanse was dosed orally once daily at either 30, 50 or 70 mg (depending on the outcome of the dose optimization phase)for 1 week in the first intervention and matching placebo was given orally once daily for 1 week in the second intervention |
| FG001 | Placebo First |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Enrolled (Dose-optimization Phase) |
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| Placebo | Drug | Placebo |
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| Irvine |
| California |
| United States |
| Shire Clinical Research Site | Wildomar | California | United States |
| Vince and Associates Clinical Research | Overland Park | Kansas | United States |
| Center for Psychiatry & Behavioral Medicine Inc | Las Vegas | Nevada | United States |
| Duke Child & Family Study Center | Durham | North Carolina | United States |
| Duke University Medical Center | Durham | North Carolina | United States |
| Shire Clinical Research Site | Houston | Texas | United States |
| Shire Clinical Research Site | Lubbock | Texas | United States |
Matching placebo was given orally once daily for 1 week in the first intervention and Vyvanse was dosed orally once daily at either 30, 50 or 70 mg (depending on the outcome of the dose optimization phase)for 1 week in the second intervention |
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| NOT COMPLETED |
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| First Intervention (Cross-over Phase) |
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| Second Intervention (Cross-over Phase) |
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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 | ||||||||||||||
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Onset of Effect of Vyvanse | The onset of effect will be defined as the first assessment time showing statistical significance between Vyvanse and placebo as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Deportment scale. The degree of impairment is rated from 0 (normal) to 6 (maximal). | Analysis on the intention-to-treat (ITT) population. | Posted | Least Squares Mean | Standard Error | scores on a scale | Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose. |
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| Secondary | Duration of Effect of Vyvanse | Duration of effect will be defined as the first time point at which there is a non-significant difference between Vyvanse and placebo after a time point at which there is a significant difference between the two treatment groups as measured by SKAMP Deportment Scores. The degree of impairment is rated from 0 (normal) to 6 (maximal). | Analysis on intention-to-treat (ITT) population. | Posted | Least Squares Mean | Standard Error | scores on a scale | Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose. |
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The Randomized Population is defined as all subjects who are randomized and received at least one dose of study medication during the Cross-Over Phase of the study.
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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 | Vyvanse | 0 | 115 | 13 | 115 | |||
| EG001 | Placebo | 0 | 115 | 3 | 115 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased Appetite | Metabolism and nutrition disorders |
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| Headache | Nervous system 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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| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Protocol Violation |
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| 5 hours |
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| 7.5 hours |
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| 10 hours |
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| 12 hours |
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| 13 hours |
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| Statistical analysis of SKAMP scores at 2.5 hours post-dose | ANCOVA | Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect. | <0.0001 | The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons. | 95 | Superiority or Other (legacy) |
| Statistical analysis of SKAMP scores at 5.0 hours post-dose | ANCOVA | Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect. | <0.0001 | The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons. | 95 | Superiority or Other (legacy) |
| Statistical analysis of SKAMP scores at 7.5 hours post-dose | ANCOVA | Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect. | <0.0001 | The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons. | 95 | Superiority or Other (legacy) |
| Statistical analysis of SKAMP scores at 10.0 hours post-dose | ANCOVA | Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect. | <0.0001 | The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons. | 95 | Superiority or Other (legacy) |
| Statistical analysis of SKAMP scores at 12.0 hours post-dose | ANCOVA | Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect. | <0.0001 | The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons. | 95 | Superiority or Other (legacy) |
| Statistical analysis of SKAMP scores at 13.0 hours post-dose | ANCOVA | Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect. | <0.0001 | The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons. | 95 | Superiority or Other (legacy) |
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