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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
History of Changes
  Purpose

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 Intervention Phase
Attention Deficit Hyperactivity Disorder
ADHD
 Drug: Methylphenidate Hydrochloride Extended Release Capsules
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rhodes Pharmaceuticals, L.P.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 27
Study Start Date: December 2010
Study Completion Date: February 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: Placebo
Capsule without active drug
Other Name: Biphentin placebo

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269463

Locations
United States, California
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.
  More Information

No publications provided

Responsible Party: Rhodes Pharmaceuticals, L.P.
ClinicalTrials.gov Identifier: NCT01269463     History of Changes
Other Study ID Numbers: RP-BP-EF001
Study First Received: December 31, 2010
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Rhodes Pharmaceuticals, L.P.:
Attention deficit
Hyperactivity
Impulsivity
Inattention

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
 Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013