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

• Status: Completed
• Trial end date: 2002-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Methylphenidate

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.