Methylphenidate for Treating Attention Deficit Hyperactivity Disorder in Children With Both ADHD and Epilepsy
Condition: Attention Deficit Disorder With Hyperactivity; Epilepsy
MeSH terms: Epilepsy; Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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.
    

Intervention name(s): Extended Release Methylphenidate (OROS-Methylphenidate)
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): Concerta
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Seizures; Methylphenidate; Stimulant