A Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD)
This study has been completed.
Sponsor:
Shire Development LLC
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00500149
First received: July 10, 2007
Last updated: February 4, 2011
Last verified: February 2011
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder |
Drug: Vyvanse (lisdexamfetamine dimesylate) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase IIIb, Randomized, Double-Blind, Multi-Center, Placebo- Controlled, Dose-Optimization, Cross-Over, Analog Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention-Deficit/Hyperactivity Disorder |
Resource links provided by NLM:
Further study details as provided by Shire Development LLC:
Primary Outcome Measures:
- Onset of Effect of Vyvanse [ Time Frame: Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose. ] [ Designated as safety issue: No ]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).
Secondary Outcome Measures:
- Duration of Effect of Vyvanse [ Time Frame: Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose. ] [ Designated as safety issue: Yes ]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).
| Enrollment: | 129 |
| Study Start Date: | June 2007 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Vyvanse (lisdexamfetamine dimesylate)
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).
|
| Placebo Comparator: 2 |
Drug: Placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject is a male or female aged 6-12 years inclusive at the time of consent.
- Females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to comply with any applicable contraceptive requirements of the protocol.
- Primary diagnosis of ADHD: combined sub-type or predominantly hyperactive impulsive sub-type based on a detailed psychiatric evaluation.
- Subject has a baseline ADHD-RS-IV score ≥ 28.
- Intelligent Quotient (IQ) score of 80 or above on the Kaufman Brief Intelligence Test (KBIT).
- Subject must be able to complete at least the Basic Test of the PERMP assessment.
Exclusion Criteria:
- Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as Post Traumatic Stress Disorder (PTSD), psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder
- Subject has Conduct Disorder.
- Subject has a documented allergy, hypersensitivity or intolerance to amphetamines.
- Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
- The subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine) in accordance with DSM-IV-TR criteria.
- Subject weighs less than 50 pounds (22.7kg).
- Subject is significantly overweight
- Subject had a history of seizures during the last two years (exclusive of febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
- Subject has any reported history of abnormal thyroid function.
- Subject has taken another investigational drug or taken part in a clinical trial within the last 30 days prior to Screening.
- Subject has a known history of structural cardiac abnormality, as well as any other condition(s) that may affect cardiac performance.
- Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments
- Subject is taking other medications that have central nervous system (CNS) effects or affect performance, such as sedating antihistamines and decongestant sympathomimetics (bronchodilators are not exclusionary).
- The female subject is pregnant or lactating.
- Subject is well controlled on their current ADHD medication with acceptable tolerability.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500149
Locations
| United States, Arkansas | |
| Clinical Study Centers, LLC | |
| Little Rock, Arkansas, United States | |
| United States, California | |
| Univ. of CA, Irvine Child Development Center | |
| Irvine, California, United States | |
| Shire Clinical Research Site | |
| Wildomar, California, United States | |
| United States, Kansas | |
| Vince and Associates Clinical Research | |
| Overland Park, Kansas, United States | |
| United States, Nevada | |
| Center for Psychiatry & Behavioral Medicine Inc | |
| Las Vegas, Nevada, United States | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States | |
| Duke Child & Family Study Center | |
| Durham, North Carolina, United States | |
| United States, Texas | |
| Shire Clinical Research Site | |
| Houston, Texas, United States | |
| Shire Clinical Research Site | |
| Lubbock, Texas, United States | |
Sponsors and Collaborators
Shire Development LLC
Investigators
| Principal Investigator: | Sharon B Wigal, PhD | UCI Irvine |
More Information
Additional Information:
FDA-approved label 
Publications:
Wigal SB, Kollins SH, Childress AC, et al. Efficacy and Tolerability of Lisdexamfetamine Dimesylate in Children With Attention-Deficit/Hyperactivity Disorder: Sex and Age Effects and Effect Size Across the Day. Child and Adolescent Psychiatry and Mental Health, 14 December 2010; 4:32
| Responsible Party: | Timothy Whitaker, M.D., Shire Pharmaceutical |
| ClinicalTrials.gov Identifier: | NCT00500149 History of Changes |
| Other Study ID Numbers: | SPD489-311 |
| Study First Received: | July 10, 2007 |
| Results First Received: | December 2, 2008 |
| Last Updated: | February 4, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Dextroamphetamine |
Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013