Back to resultsSafety and Efficacy Study of Dexmethylphenidate in Children With ADHD
Primary Purpose
ADHD
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Focalin XR
Sponsored by
About this trial
This is an interventional prevention trial for ADHD focused on measuring ADHD, children
Eligibility Criteria
Inclusion Criteria: DSM-IV diagnosis of ADHD Males and females aged 6-12 Exclusion Criteria: Inability to understand or follow instructions Is pregnant Diagnosis of tic disorder History of seizure disorder
Sites / Locations
- Bayou City Research
Outcomes
Primary Outcome Measures
Change in attention and deportment measured at 2 hours post-dose
Secondary Outcome Measures
Onset of effect at 0.5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 hours post-dose
Parent's assessment of patient behavior across all treatment periods as measured by the change from baseline
Safety and tolerability of two doses of dexmethylphenidate compared to two doses of an approved, long-acting, marketed medication for ADHD and placebo in children ages 6-12 diagnosed with ADHD.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00141050
Brief Title
Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD
Official Title
Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD (MPH) and placebo in children ages 6-12 diagnosed with ADHD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD, children
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
90 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Focalin XR
Primary Outcome Measure Information:
Title
Change in attention and deportment measured at 2 hours post-dose
Secondary Outcome Measure Information:
Title
Onset of effect at 0.5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 hours post-dose
Title
Parent's assessment of patient behavior across all treatment periods as measured by the change from baseline
Title
Safety and tolerability of two doses of dexmethylphenidate compared to two doses of an approved, long-acting, marketed medication for ADHD and placebo in children ages 6-12 diagnosed with ADHD.
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:
DSM-IV diagnosis of ADHD
Males and females aged 6-12
Exclusion Criteria:
Inability to understand or follow instructions
Is pregnant
Diagnosis of tic disorder
History of seizure disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Brams, MD
Organizational Affiliation
Bayou City Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bayou City Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77007
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD
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