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

UCB Pharma184 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

184

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

Methylphenidate Extended Release CapsulesDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

School Day Efficacy

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

1.5 - 7.5 hours post-dosing

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.