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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00323947 |
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.
Condition | Intervention | Phase |
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Attention Deficit Disorder With Hyperactivity Epilepsy |
Drug: Extended Release Methylphenidate (OROS-Methylphenidate) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Double Blind, Placebo Controlled, Crossover Study of Extended Release Methylphenidate for Treatment of ADHD in Children With Epilepsy |
Estimated Enrollment: | 79 |
Study Start Date: | May 2003 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Participants will take OROS-MPH then switch to placebo
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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.
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2: Placebo Comparator
Participants will take placebo then switch to OROS-MPH
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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.
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Epilepsy is a brain disorder in which clusters of nerve cells in the brain periodically send abnormal signals. The normal pattern of nerve cell activity, therefore, becomes disrupted, which can result in seizures. Some symptoms of epileptic seizures include the following: strange sensations, emotions, or behavior; convulsions; muscle spasms; and loss of consciousness. Children with epilepsy are at risk for other specific disorders, such as ADHD, one of the most common mental disorders in children. ADHD is characterized by impulsiveness, hyperactivity, and inattention. Approximately one third of children with epilepsy also have ADHD. Stimulant medication is a common treatment method for ADHD. The effect of stimulant treatment on epilepsy and seizure frequency, however, is unknown. This study will evaluate the safety and effectiveness of XR-MPH, a stimulant medication, in treating ADHD in children with both ADHD and epilepsy.
People interested in participating in this double-blind study will first attend two visits for interviews and evaluations to determine eligibility for participation. Upon study entry, participants will be randomly assigned to initially receive either XR-MPH or placebo. Medication dosages and duration in the study will depend on participants' weights. Participants will first take either immediate release MPH or placebo "A" for 1 day. Any participants who experience an adverse event will be removed from the study. 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. Following the washout, participants will switch to the other treatment group for the remainder of the study and will receive either XR-MPH or placebo in the same manner. Participants will attend weekly study visits, at which they will receive medication and undergo assessments of ADHD symptoms and medication side effects. Blood will be drawn to assess medication levels at the first study visit and following both rounds of treatment. Participants who have trouble with transportation to and from the study site may complete some study visits via telephone. Upon study completion, all participants will be offered clinical treatment with the study physician. Follow-up visits will be held every 2 to 6 months for patients who choose to continue receiving care from the study physician.
Ages Eligible for Study: | 6 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Joseph M. Gonzalez-Heydrich, MD | 617-355-6680 | joseph.gonzalez-heydrich@childrens.harvard.edu |
Contact: Jane Whitney, BA | 617-355-2353 | jane.whitney@childrens.harvard.edu |
United States, Massachusetts | |
Childrens Hospital Boston | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Joseph M. Gonzalez-Heydrich, MD 617-355-6680 joseph.gonzalez-heydrich@childrens.harvard.edu | |
Contact: Jane Whitney, BA 617-355-2353 jane.whitney@childrens.harvard.edu |
Principal Investigator: | Joseph M. Gonzalez-Heydrich, MD | Children's Hospital Boston, Harvard Medical School |
Responsible Party: | Children's Hospital Boston/Harvard Medical School ( Joseph Gonzalez-Heydrich, MD ) |
Study ID Numbers: | K23 MH66835, DDTR BK-TKND |
Study First Received: | May 8, 2006 |
Last Updated: | August 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00323947 |
Health Authority: | United States: Federal Government |
ADHD Seizures Methylphenidate Stimulant |
Seizures Central Nervous System Diseases Attention Deficit and Disruptive Behavior Disorders Methylphenidate Brain Diseases Dyskinesias Signs and Symptoms |
Dopamine Attention Deficit Disorder with Hyperactivity Epilepsy Mental Disorders Mental Disorders Diagnosed in Childhood Hyperkinesis Neurologic Manifestations |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Disease Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs |
Central Nervous System Stimulants Pharmacologic Actions Pathologic Processes Therapeutic Uses Dopamine Agents Central Nervous System Agents |