Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD - Full Text View

Sponsored by:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00500071

Purpose

Assess the efficacy & tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect.

Condition	Intervention	Phase
ADHD	Drug: Vyvanse (lisdexamfetamine dimesylate)	Phase IV

Drug Information available for: Lisdexamfetamine Lisdexamfetamine dimesylate

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Efficacy Study
Official Title:	A Prospective, Open-Label, Multi-Center, Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) 20-70mg in Children Aged 6-12 Diagnosed With ADHD

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:

ADHD-RS-IV score [ Time Frame: time change from baseline at Day 49 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ADHD-RS-IV, CGI-I, PGA, the BRIEF, the EESC, and the MSQ. [ Time Frame: baseline to day 49 ] [ Designated as safety issue: Yes ]

Enrollment:	318
Study Start Date:	July 2007
Study Completion Date:	April 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Vyvanse (lisdexamfetamine dimesylate) Vyvanse™ 20mg once daily at 7 a.m.; dose increased weekly by 10mg until an acceptable response is achieved. Titration may proceed to a maximum daily dose 70mg/day.

Eligibility

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 based on a detailed psychiatric evaluation.
Subjects must have a baseline ADHD-RS-IV total score ≥28.
Subject is functioning at an age-appropriate level intellectually.
comply with all the testing and requirements.
Subject is able to swallow a capsule.
Subject has blood pressure measurements within the 95th percentile for age, gender, and height.

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, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder or other symptomatic manifestations.
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.
Subject has a positive urine drug result.
Subject weighs less than 50 pounds (22.7kg).
Subject is significantly overweight.
Subject has a history of seizures (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 product or taken part in a clinical trial within 30 days prior to Screening.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500071

Sponsors and Collaborators

Shire Pharmaceutical Development

Investigators

Principal Investigator:

Robert L Finding, MD

University Hospitals Case Medical Center

More Information

Responsible Party:	Shire Pharmaceutical ( Timothy Whitaker, M.D. )
Study ID Numbers:	SPD489-310
Study First Received:	July 10, 2007
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00500071
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dopamine
Dextroamphetamine

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Physiological Effects of Drugs
Central Nervous System Stimulants
Dopamine Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009