Primary Outcome Measures:
- Seizure occurence [ Time Frame: Measured between Weeks 1 and 4 ] [ Designated as safety issue: Yes ]
- Clinical administered scores on the ADHD Rating Scale IV Parent Version [ Time Frame: Measured between Weeks 1 and 4 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- CGI-ADHD-Severity [ Time Frame: Measured between Weeks 1 and 4 ] [ Designated as safety issue: No ]
- ADHD Rating Scale IV Teacher Version [ Time Frame: Measured between Weeks 1 and 4 ] [ Designated as safety issue: No ]
- Scores on the Barkley Side Effects Checklist-Modified [ Time Frame: Measured between Weeks 1 and 4 ] [ Designated as safety issue: Yes ]
- Clinical Global Impressions (CGI)-ADHD-Improvement [ Time Frame: Measured between Weeks 1 and 4 ] [ Designated as safety issue: No ]
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)
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.
Purpose
