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

Sponsor

Rhodes Pharmaceuticals, L.P. (Industry)

Overall Status

Completed

CT.gov ID

NCT01269463

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder ADHD	Drug: Methylphenidate Hydrochloride Extended Release Capsules Drug: Placebo	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

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

Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Biphentin
Placebo Comparator: Capsule without active drug Double blind crossover assignment of the placebo comparator.	Drug: Placebo Capsule without active drug Other Names: Biphentin placebo

Arm

Intervention/Treatment

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 Names:

Biphentin

Placebo Comparator: Capsule without active drug

Double blind crossover assignment of the placebo comparator.

Drug: Placebo

Capsule without active drug

Other Names:

Biphentin placebo

Outcome Measures

Primary Outcome Measures

Comparison following treatment between drug and placebo using evaluation by SKAMP Combined, Attention, and Deportment Scales [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.

Secondary Outcome Measures

Comparison following treatment with drug or placebo using PERMP (Permanent Product of arithmetic) evaluations [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

IQ less than 80 WASI.
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.
Chronic medical illnesses: seizure, hypertension, thyroid disease, cardiac, family history of sudden death, glaucoma.
Use of psychotropic CNS meds having effect exceeding 14 days from screening.
Planned use of prohibited drugs.
Is pregnant or breast-feeding.
Significant ECG or laboratory abnormalities.
Experimental drug or medical device within 30 days prior to screening.
Hypersensitivity to methylphenidate.
Inability or unwillingness to comply with protocol.
Well controlled on current ADHD treatment.
Inability to take oral capsules.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Irvine/Child Development Center	Irvine	California	United States	92612

Sponsors and Collaborators

Rhodes Pharmaceuticals, L.P.

Investigators

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.