Time Course of Response to Methylphenidate HCl ER Capsules in Children 6 to 12 Years With ADHD in Classroom Setting
|Attention Deficit Hyperactivity Disorder ADHD||Drug: Methylphenidate Hydrochloride Extended Release Capsules Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind Study of the Time Course of Response to Biphentin Methylphenidate Hydrochloride ER Capsules Compared to Placebo in Children 6 to 12 Years With Attention Deficit Hyperactivity Disorder in Analog Classroom Setting|
- Comparison following treatment between drug and placebo using evaluation by SKAMP Combined, Attention, and Deportment Scales [ Time Frame: pre-dose, 1.0, 2.0, 3.0, 4.5, 6.0, 7.5, 9.0, 10.5, and 12 hours ]Comparison of measurement scores following drug dose versus placebo.
- Comparison following treatment with drug or placebo using PERMP (Permanent Product of arithmetic) evaluations [ Time Frame: Pre-dose, 1.0, 2.0, 3.0, 4.5, 6.0, 7.5, 9.0, 10.5, and 12 hours ]Comparison of measurement scores following drug dose versus placebo.
|Study Start Date:||December 2010|
|Study Completion Date:||February 2012|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Methylphenidate HCl ER Capsules
Methylphenidate hydrochloride extended release capsules
Drug: Methylphenidate Hydrochloride Extended Release Capsules
Methylphenidate Hydrochloride Extended Release Capsules to be dosed once daily
Other Name: Biphentin
Placebo Comparator: Capsule without active drug
Double blind crossover assignment of the placebo comparator.
Capsule without active drug
Other Name: Biphentin placebo
Biphentin methylphenidate hydrochloride extended release capsules is provided in multiple strengths of 10, 15, 20, 30, 40, 50, and 60 mg to be administered once daily. Once daily dosing is intended to provide treatment for the substantial day.
For current analog classroom study each eligible subject will be optimized at 15, 20, 30, or 40 mg in a timeframe of five weekly periods. In the sixth week each subject will be randomized double-blind to receive either active comparator at the optimized dose or placebo comparator treatment. The first classroom session will be held at the end of the week, when efficacy measurements including SKAMP and PERMP tests will be administered. At the beginning of the following week, the subjects will be crossed-over to the corresponding active comparator or placebo comparator treatment. The second classroom session will be held at the end of the second double-blind week, when the same efficacy measurements will be administered.
Various safety and tolerability, and quality of life assessments will be conducted.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269463
|United States, California|
|University of California, Irvine/Child Development Center|
|Irvine, California, United States, 92612|
|Study Director:||Wei-wei Chang, Ph.D.||NuTec Incorporated|
|Principal Investigator:||Sharon B. Wigal, Ph.D.||University of California, Irvine / Child Development Center|
|Study Chair:||Robert Kupper, Ph.D.||Rhodes Pharmaceuticals, L.P.|