Back to resultsThe COMACS Study: A Comparison of Methylphenidates in an Analog Classroom Setting
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Methylphenidate Extended Release Capsules
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Methylphenidate, Metadate CD, Concerta, COMACS, Attention Deficit Hyperactivity Disorder (ADHD)
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
School Day Efficacy
SKAMP (Swanson Kotkin Agler MFlynn Pelham) ADHD Rating Scale: Deportment Items
1.5 - 7.5 hours post-dosing
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00381758
Brief Title
The COMACS Study: A Comparison of Methylphenidates in an Analog Classroom Setting
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 Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
August 2002 (Actual)
Study Completion Date
August 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, Methylphenidate, Metadate CD, Concerta, COMACS, Attention Deficit Hyperactivity Disorder (ADHD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
184 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Methylphenidate Extended Release Capsules
Primary Outcome Measure Information:
Title
School Day Efficacy
Title
SKAMP (Swanson Kotkin Agler MFlynn Pelham) ADHD Rating Scale: Deportment Items
Title
1.5 - 7.5 hours post-dosing
Secondary Outcome Measure Information:
Title
SKAMP Attention Items, 1.5-12 hrs;
Title
PERMP (Permanent Product of arithmetic) (# Problems Attempted & # Complete), 1.5-12 hrs;
Title
SNAP IV (Swanson Nolan Pelham), day 3 & 7;
Title
Treatment Emergent Adverse Events, once weekly;
Title
Barkley Symptom scale, once weekly
Title
Patient Satisfaction,once weekly
Title
Parent Satisfaction & Treatment Preference once weekly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Hatch
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
The COMACS Study: A Comparison of Methylphenidates in an Analog Classroom Setting
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