The COMACS Study: A Comparison of Methylphenidates in an Analog Classroom Setting

Phase 4

Completed

• Conditions: Attention Deficit Hyperactivity Disorder

• Registration Number: NCT00381758
• Lead Sponsor: UCB Pharma

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2002-08
• Study Completion: 2002-08
• Study First Submitted: 2006-09-26
• Study First Submitted QC: 2006-09-27
• Study First Posted: 2006-09-28
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-07
• Last Update Posted: 2008-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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