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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00381758
Recruitment Status : Completed
First Posted : September 28, 2006
Last Update Posted : March 10, 2008
Sponsor:
Information provided by:
UCB Pharma

Brief 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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: Methylphenidate Extended Release Capsules Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : May 2002
Actual Primary Completion Date : August 2002
Actual Study Completion Date : August 2002





Primary Outcome Measures :
  1. School Day Efficacy
  2. SKAMP (Swanson Kotkin Agler MFlynn Pelham) ADHD Rating Scale: Deportment Items
  3. 1.5 - 7.5 hours post-dosing

Secondary Outcome Measures :
  1. SKAMP Attention Items, 1.5-12 hrs;
  2. PERMP (Permanent Product of arithmetic) (# Problems Attempted & # Complete), 1.5-12 hrs;
  3. SNAP IV (Swanson Nolan Pelham), day 3 & 7;
  4. Treatment Emergent Adverse Events, once weekly;
  5. Barkley Symptom scale, once weekly
  6. Patient Satisfaction,once weekly
  7. Parent Satisfaction & Treatment Preference once weekly


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00381758


Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: Simon Hatch UCB Pharma
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ClinicalTrials.gov Identifier: NCT00381758    
Other Study ID Numbers: CD00600
First Posted: September 28, 2006    Key Record Dates
Last Update Posted: March 10, 2008
Last Verified: March 2008
Keywords provided by UCB Pharma:
ADHD
Methylphenidate
Metadate CD
Concerta
COMACS
Attention Deficit Hyperactivity Disorder (ADHD)
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents