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Methylphenidate for Treating Attention Deficit Hyperactivity Disorder in Children With Both ADHD and Epilepsy

NCT00323947 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2013-08-01

No results posted yet for this study

Summary

This study will evaluate the safety and effectiveness of extended release methylphenidate (XR-MPH) in treating attention deficit hyperactivity disorder (ADHD) in children with both ADHD and epilepsy.

Conditions

  • Attention Deficit Disorder With Hyperactivity
  • Epilepsy

Interventions

DRUG

Extended Release Methylphenidate (OROS-Methylphenidate)

Participants will first take either immediate release MPH or placebo "A" for 1 day. On Day 2 of treatment, participants assigned to receive XR-MPH will begin taking it, and participants assigned to receive placebo will switch to placebo "B." This treatment phase will continue for 6 days to 4 weeks, depending on weight, and will then be followed by a 1-week medication washout period. Target dose depends on the weight of the participant. Possible dose forms include 18, 36, 54 mg OROS-MPH.

Sponsors & Collaborators

Principal Investigators

  • Joseph M. Gonzalez-Heydrich, MD · Children's Hospital Boston, Harvard Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • United States

Study Locations

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Diseases
Companies

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 NCT00323947 on ClinicalTrials.gov