Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 - Full Text View

Sponsored by:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00763971

Purpose

The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD.

Condition	Intervention	Phase
ADHD	Drug: LDX Drug: Methylphenidate Hydrochloride Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	A Phase III, Randomised, Double-Blind, Multicentre, Parallel-Group, Placebo- and Active-Controlled, Dose-Optimisation Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Resource links provided by NLM:

Drug Information available for: Methylphenidate Lisdexamfetamine Lisdexamfetamine dimesylate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:

ADHD Rating Scale [ Time Frame: Weekly for 7 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CPRS-R CGI-I WFIRS-P CHIP-CE/PRF HUI-2 Safety [ Time Frame: Weekly for safety, CPRS-R, CGI-I. At week 4 and week 7 for HUI, Week 7 for CHIP-CE/PRF and WFIRS-P ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	333
Study Start Date:	October 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
LDX: Experimental Overencapsulated LDX 30, 50, or 70mg	Drug: LDX 30, 50 or 70mg capsule once per day (Overencapsulated)
Concerta: Active Comparator Overencapsulated Concerta 18, 36, or 54mg	Drug: Methylphenidate Hydrochloride 18, 36, or 54mg tablet one per day (Overencapsulated)
Placebo: Placebo Comparator Overencapsulated Placebo	Drug: Placebo Placebo capsule once per day (Overencapsulated)

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject is a male or female aged 6-17 years inclusive at the time of consent.
Subject must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.
Subject must have a Baseline ADHD-RS-IV total score ≥28.
Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Screening and Baseline.
Subject is able to swallow a capsule.

Exclusion Criteria:

Subject has failed to respond to more than one adequate course (dose and duration) of stimulant therapy.

One course must have been a long-acting formulation.
Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary.
Subject is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently, demonstrating active suicidal ideation.
Subject has glaucoma.
Subject weighs less than 22.7kg (50lbs).
Subject is significantly overweight based on Centre for Disease Control and Prevention Body Mass Index (BMI)-for-age gender specific charts at Screening. Significantly overweight is defined as a BMI >97th percentile for this study.
Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or methylphenidate.
Subject has a documented allergy, hypersensitivity, or intolerance to any excipients in the test or reference products.
Subject has a history of seizures (other than infantile febrile seizures), a tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.
Subject has a known history of symptomatic cardiovascular disease, advance arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
Subject is well controlled on their current ADHD medication with acceptable tolerability.
Subject has a pre-existing severe gastrointestinal tract narrowing (pathologic or iatrogenic).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763971

Contacts

Contact: Shire Call Center

+1 866 842 5335

Show 56 Study Locations

Sponsors and Collaborators

Shire Pharmaceutical Development

More Information

No publications provided

Responsible Party:	Shire Pharmaceutical ( Timothy Whitaker, MD )
Study ID Numbers:	SPD489-325
Study First Received:	September 30, 2008
Last Updated:	September 10, 2009
ClinicalTrials.gov Identifier:	NCT00763971 History of Changes
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Belgium: Federal Agency for Medicinal Products and Health Products; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Dopamine
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Dextroamphetamine

Mental Disorders Diagnosed in Childhood
Methylphenidate
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Central Nervous System Stimulants
Dopamine Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Attention Deficit and Disruptive Behavior Disorders
Methylphenidate
Central Nervous System Stimulants

Pharmacologic Actions
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Therapeutic Uses
Dextroamphetamine
Mental Disorders Diagnosed in Childhood
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009