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Time Course of Response to Methylphenidate HCl ER Capsules in Children 6 to 12 Years With ADHD in Classroom Setting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rhodes Pharmaceuticals, L.P.
ClinicalTrials.gov Identifier:
NCT01269463
First received: December 31, 2010
Last updated: January 22, 2013
Last verified: January 2013

December 31, 2010
January 22, 2013
December 2010
June 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Comparison of measurement scores following drug dose versus placebo.
Same as current
Complete list of historical versions of study NCT01269463 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Comparison of measurement scores following drug dose versus placebo.
Same as current
Not Provided
Not Provided
 
Time Course of Response to Methylphenidate HCl ER Capsules in Children 6 to 12 Years With ADHD in Classroom Setting
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

The time course of response following one dose of a new methylphenidate hydrochloride extended release capsule is studied in children 6-12 years in a simulated laboratory classroom setting. Biphentin methylphenidate hydrochloride extended release capsule has been formulated for daily dosing to provide treatment of a child with ADHD for the substantial day.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Attention Deficit Hyperactivity Disorder
  • ADHD
  • Drug: Methylphenidate Hydrochloride Extended Release Capsules
    Methylphenidate Hydrochloride Extended Release Capsules to be dosed once daily
    Other Name: Biphentin
  • Drug: Placebo
    Capsule without active drug
    Other Name: Biphentin placebo
  • Active Comparator: Methylphenidate HCl ER Capsules
    Methylphenidate hydrochloride extended release capsules
    Intervention: Drug: Methylphenidate Hydrochloride Extended Release Capsules
  • Placebo Comparator: Capsule without active drug
    Double blind crossover assignment of the placebo comparator.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
February 2012
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Males and females ages 6 to 12.
  2. ADHD diagnosis with ADHD-RS-IV scores ≥ 90th percentile.
  3. In need of treatment for ADHD and able to have 2-day washout from previous medication.
  4. Females of child-bearing potential not pregnant and practice birth control.
  5. Subject and parent/guardian willing to comply with protocol.
  6. Signed consent and assent.

Exclusion Criteria:

  1. IQ less than 80 WASI.
  2. Current primary psychiatric diagnosis of: severe anxiety disorder, conduct disorder, psychotic disorders, pervasive developmental disorder, eating disorder, obsessive-compulsive disorder, major depressive disorder, bipolar disorder, substance use disorder, chronic tic disorder, personal or family history of Tourette's Syndrome.
  3. Chronic medical illnesses: seizure, hypertension, thyroid disease, cardiac, family history of sudden death, glaucoma.
  4. Use of psychotropic CNS meds having effect exceeding 14 days from screening.
  5. Planned use of prohibited drugs.
  6. Is pregnant or breast-feeding.
  7. Significant ECG or laboratory abnormalities.
  8. Experimental drug or medical device within 30 days prior to screening.
  9. Hypersensitivity to methylphenidate.
  10. Inability or unwillingness to comply with protocol.
  11. Well controlled on current ADHD treatment.
  12. Inability to take oral capsules.
Both
6 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01269463
RP-BP-EF001
No
Rhodes Pharmaceuticals, L.P.
Rhodes Pharmaceuticals, L.P.
Not Provided
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.
Rhodes Pharmaceuticals, L.P.
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP