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

UCB

Status and phase

Completed

Phase 4

Conditions

Attention Deficit Hyperactivity Disorder

Treatments

Drug: Methylphenidate Extended Release Capsules

Study type

Interventional

Funder types

Industry

Identifiers

NCT00381758

CD00600

Details and patient eligibility

About

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.

Sex

All

Ages

6 to 12 years old

Volunteers

No Healthy Volunteers

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.