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)

NCT00500149 | Completed Phase 3 Results

• 1 other identifier: SPD489-311
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 9

Brief Summary

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).

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Duration of Effect of Vyvanse

  Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose.

Study Arms (2)

1

EXPERIMENTAL

Drug: Vyvanse (lisdexamfetamine dimesylate)

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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).

1

Placebo DRUG

Placebo

2

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• The female subject is pregnant or lactating.
• Subject is well controlled on their current ADHD medication with acceptable tolerability.

Sponsors & Collaborators

• Shire: lead

Study Sites (9)

Clinical Study Centers, LLC

Little Rock, Arkansas, United States

Location

Univ. of CA, Irvine Child Development Center

Irvine, California, United States

Location

Shire Clinical Research Site

Wildomar, California, United States

Location

Vince and Associates Clinical Research

Overland Park, Kansas, United States

Location

Center for Psychiatry & Behavioral Medicine Inc

Las Vegas, Nevada, United States

Location

Duke Child & Family Study Center

Durham, North Carolina, United States

Location

Duke University Medical Center

Durham, North Carolina, United States

Location

Shire Clinical Research Site

Houston, Texas, United States

Location

Shire Clinical Research Site

Lubbock, Texas, United States

Location

Related Publications (2)

• 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.

  PMID: 19508731 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.

  PMID: 21156071 RESULT

Related Links

• FDA Recall Information

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 12, 2007
• Study Start: June 13, 2007
• Primary Completion: December 5, 2007
• Study Completion: December 5, 2007
• Last Updated: June 14, 2021
• Results First Posted: June 5, 2009

Record last verified: 2021-06

Locations

US (9)