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

Attention Deficit Hyperactivity Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381758
• Other study ID #: CD00600
• Status: Completed
• Phase: Phase 4
• First received: September 26, 2006
• Last updated: March 7, 2008
• Start date: May 2002
• Est. completion date: August 2002

Study information

• Verified date: March 2008
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: August 2002
• Est. primary completion date: August 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Methylphenidate Extended Release Capsules

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	School Day Efficacy
Primary	SKAMP (Swanson Kotkin Agler MFlynn Pelham) ADHD Rating Scale: Deportment Items
Primary	1.5 - 7.5 hours post-dosing
Secondary	SKAMP Attention Items, 1.5-12 hrs;
Secondary	PERMP (Permanent Product of arithmetic) (# Problems Attempted & # Complete), 1.5-12 hrs;
Secondary	SNAP IV (Swanson Nolan Pelham), day 3 & 7;
Secondary	Treatment Emergent Adverse Events, once weekly;
Secondary	Barkley Symptom scale, once weekly
Secondary	Patient Satisfaction,once weekly
Secondary	Parent Satisfaction & Treatment Preference once weekly