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

Condition(s) targeted: Attention Deficit Hyperactivity Disorder

Intervention: Methylphenidate Extended Release Capsules (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: UCB

Official(s) and/or principal investigator(s):
Simon Hatch, Study Director, Affiliation: UCB

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.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment

Primary outcome:

School Day Efficacy

SKAMP (Swanson Kotkin Agler MFlynn Pelham) ADHD Rating Scale: Deportment Items

1.5 - 7.5 hours post-dosing

Secondary outcome:

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

Minimum age: 6 Years. Maximum age: 12 Years. Gender(s): Both.

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.

Starting date: May 2002
Ending date: August 2002
Last updated: March 7, 2008