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:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00500149
First received: July 10, 2007
Last updated: February 4, 2011
Last verified: February 2011
  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:

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:

  1. Subject is a male or female aged 6-12 years inclusive at the time of consent.
  2. 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.
  3. Primary diagnosis of ADHD: combined sub-type or predominantly hyperactive impulsive sub-type based on a detailed psychiatric evaluation.
  4. Subject has a baseline ADHD-RS-IV score ≥ 28.
  5. Intelligent Quotient (IQ) score of 80 or above on the Kaufman Brief Intelligence Test (KBIT).
  6. Subject must be able to complete at least the Basic Test of the PERMP assessment.

Exclusion Criteria:

  1. 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
  2. Subject has Conduct Disorder.
  3. Subject has a documented allergy, hypersensitivity or intolerance to amphetamines.
  4. Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
  5. 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.
  6. Subject weighs less than 50 pounds (22.7kg).
  7. Subject is significantly overweight
  8. 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.
  9. Subject has any reported history of abnormal thyroid function.
  10. Subject has taken another investigational drug or taken part in a clinical trial within the last 30 days prior to Screening.
  11. Subject has a known history of structural cardiac abnormality, as well as any other condition(s) that may affect cardiac performance.
  12. 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
  13. 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).
  14. The female subject is pregnant or lactating.
  15. Subject is well controlled on their current ADHD medication with acceptable tolerability.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Child & Family Study Center
Durham, North Carolina, United States
Duke University Medical 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
Investigators
Principal Investigator: Sharon B Wigal, PhD UCI Irvine
  More Information

Additional Information:
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
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Dextroamphetamine
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014