The COMACS Study: A Comparison of Methylphenidates in an Analog Classroom Setting - Full Text View

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00381758

Purpose

This study was designed to compare Concerta Extended Release tablets with Metadate CD capsules in children with ADHD who were between 6 and 12 years old. The effects on ADHD symptoms, and any side effects of treatment, were measured for 12 hours after dosing in a simulated classroom. The treatments were blinded and the effects were compared with a Placebo.

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: Methylphenidate Extended Release Capsules	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind Comparison of the Time Course of Response to Two Extended-Release Oral Delivery Systems for Methylphenidate in Pediatric Patients With Attention Deficit Hyperactivity Disorder in an Analog Classroom Setting: The CoMACS Study

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

School Day Efficacy
SKAMP (Swanson Kotkin Agler MFlynn Pelham) ADHD Rating Scale: Deportment Items
1.5 - 7.5 hours post-dosing

Secondary Outcome Measures:

SKAMP Attention Items, 1.5-12 hrs;
PERMP (Permanent Product of arithmetic) (# Problems Attempted & # Complete), 1.5-12 hrs;
SNAP IV (Swanson Nolan Pelham), day 3 & 7;
Treatment Emergent Adverse Events, once weekly;
Barkley Symptom scale, once weekly
Patient Satisfaction,once weekly
Parent Satisfaction & Treatment Preference once weekly

Estimated Enrollment:	184
Study Start Date:	May 2002
Study Completion Date:	August 2002
Primary Completion Date:	August 2002 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:

6 -12 years of age, inclusive
Have a diagnosis of ADHD
Receiving an approved form of MPH (methylphenidate) and have demonstrated clinical improvement during this treatment.

Exclusion Criteria:

IQ below 80.
The patient, or a first-degree relative, has a confirmed diagnosis of Tourette's syndrome or a clinically significant tic disorder.
History of seizures (excluding uncomplicated childhood febrile seizures).
Myocardial infarction within 3 months of study entry, or has a history of cardiac disease, congenital cardiac abnormality, glaucoma, hyperthyroidism.
Comorbid psychiatric diagnosis.
Exhibits extreme aggressive behavior or destruction of property, marked anxiety, tension, or agitation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381758

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

Simon Hatch

UCB, Inc.

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00381758 History of Changes
Other Study ID Numbers:	CD00600
Study First Received:	September 26, 2006
Last Updated:	March 7, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB, Inc.:

ADHD
Methylphenidate
Metadate CD

Concerta
COMACS
Attention Deficit Hyperactivity Disorder (ADHD)

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate

Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012