Classroom Study to Assess Efficacy and Safety of MTS in Pediatric Patients Aged 6-12 With ADHD

This study has been completed.

First Received: April 25, 2007 Last Updated: November 9, 2007 History of Changes

Sponsored by:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00466791

Purpose

Evaluate the behavioral effects measured by the SKAMP deportment scale of MTS compared to placebo in children aged 6-12 with ADHD

Condition	Intervention	Phase
Attention Deficit Disorder With Hyperactivity	Drug: d,l (threo)-methylphenidate, Methylphenidate Transdermal System	Phase II

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Dose Optimization, Analog Classroom, Crossover Study Designed to Assess the Time Course of Treatment Effect, Tolerability and Safety of Methylphenidate Transdermal System (MTS) in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:

Score on SKAMP rating scale at 2,3,4.5,6,7.5,9,10.5 and 12 hours post application of MTS

Secondary Outcome Measures:

PERMP scores
Clinician-rated ADHD-RS-IV score
CGI-I score
PGA
CPRS-R score

Enrollment:	93
Study Start Date:	August 2004
Study Completion Date:	May 2005

Eligibility

Ages Eligible for Study:	6 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Primary diagnosis ADHD
Total score of greater than or equal to 26 on ADHD-RS-IV
IQ of greater than or equal to 80
Blood pressure measurements within 95th percentile for age, gender, height at screening and baseline

Exclusion Criteria:

Current controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except ODD)
Known nonresponder to psychostimulant treatment
BMI for age greater than 90th percentile
History of seizures during last 2 years
Conduct Disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466791

Locations

United States, California
UCI Child Development Center
Irvine, California, United States

Sponsors and Collaborators

Shire Pharmaceutical Development

More Information

Additional Information:

Synopsis of study results This link exits the ClinicalTrials.gov site

FDA-approved labelling information, US only This link exits the ClinicalTrials.gov site

FDA Recall information This link exits the ClinicalTrials.gov site

FDA Medical Product Safety Alerts This link exits the ClinicalTrials.gov site

Publications:

McGough JJ, Wigal SB, Abikoff H, Turnbow JM, Posner K, Moon E. A randomized, double-blind, placebo-controlled, laboratory classroom assessment of methylphenidate transdermal system in children with ADHD. J Atten Disord. 2006 Feb;9(3):476-85.

Study ID Numbers:	SPD485-201
Study First Received:	April 25, 2007
Last Updated:	November 9, 2007
ClinicalTrials.gov Identifier:	NCT00466791 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Attention Deficit and Disruptive Behavior Disorders
Methylphenidate
Central Nervous System Stimulants
Dyskinesias
Signs and Symptoms

Dopamine
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Dopamine Agents

Additional relevant MeSH terms:

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

Pharmacologic Actions
Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009