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

NCT01269463 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-12-13

Study results available
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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 Attention deficit hyperactivity disorder (ADHD) for the substantial day.

Conditions

  • Attention Deficit Hyperactivity Disorder
  • ADHD

Interventions

DRUG

Methylphenidate Hydrochloride Extended Release Capsule

An optimized dose of Methylphenidate Hydrochloride Extended Release Capsules 15, 20, 30 or 40 mg to be dosed once daily

DRUG

Placebo

Capsule without active drug

Sponsors & Collaborators

  • Rhodes Pharmaceuticals, L.P.

    lead INDUSTRY

Principal Investigators

  • Wei-wei Chang, Ph.D. · NuTec Incorporated

  • Sharon B. Wigal, Ph.D. · University of California, Irvine / Child Development Center

  • Robert Kupper, Ph.D. · Rhodes Pharmaceuticals, L.P.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-19
Primary Completion
2011-06-18
Completion
2013-03-13

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01269463 on ClinicalTrials.gov