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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00323947
First received: May 8, 2006
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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
Attention Deficit Disorder With Hyperactivity
Epilepsy
Drug: Extended Release Methylphenidate (OROS-Methylphenidate)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blind, Placebo Controlled, Crossover Study of Extended Release Methylphenidate for Treatment of ADHD in Children With Epilepsy

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

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 ]

Enrollment: 33
Study Start Date: May 2003
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Participants will take OROS-MPH then switch to placebo
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.
Other Name: Concerta
Placebo Comparator: 2
Participants will take placebo then switch to OROS-MPH
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.
Other Name: Concerta

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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Speaks English
  • Intelligence Quotient (IQ) of greater than 35 and scores greater than 35 on the Scales of Independent Behavior - Revised (SIB-R) Broad Independence Scale (both IQ and adaptive functioning at the Moderate Mental Retardation level or higher)
  • Diagnosis of epilepsy by International League Against Epilepsy (ILEA) criteria 26 (repeated, afebrile, unprovoked seizures with a seizure within the past 5 years)
  • Diagnostic and Statistical Manual (DSM)-IV diagnosis of ADHD
  • Scores at least 4 on the CGI severity scale for ADHD
  • Scores greater than 90% on the ADHD Rating Scale (ADHD RS), Parent Version; investigator scored for age and sex on either the inattentive, hyperactive-impulsive, or total score at first visit
  • Has not taken stimulants or alpha-adrenergic medications for more than 2 weeks prior to study entry
  • If taking antidepressants, neuroleptics, or lithium, doses have been stable for more than 4 weeks
  • Currently on an antiepileptic drug (AED) regimen with stable doses for more than 4 weeks prior to study entry
  • Seizure-free for more than 1 month prior to study entry
  • Prescribing clinician for epilepsy anticipates the need for a stable AED regimen for the duration of the study
  • Guardian gives permission for study personnel to communicate with prescribing epilepsy clinician
  • Teacher agrees to fill out ADHD RS at baseline and at the end of each arm of the study

Exclusion Criteria:

  • Has had a seizure within the month preceding study entry
  • Change in AED regimen or dose within 4 weeks of study entry
  • History of moderate or severe adverse event related to MPH
  • History of any psychotic disorder
  • Current acute major depression or bipolar mania
  • Current psychiatric disorder requiring pharmacotherapy (other than ADHD)
  • Unstable significant medical condition other than epilepsy
  • Any known conditions that may make treatment with MPH medically inadvisable
  • Not currently working with a physician for epilepsy treatment
  • Previously participated in a trial that provided adequate treatment with XR-MPH
  • Weighs less than 9 kg
  • Pregnant
  • Unwilling to use an effective form of contraception
  • Child has taken a stimulant (MPH, an amphetamine preparation, or pemoline), alpha-adrenergic (clonidine or guanfacine), or other ADHD medication within 2 weeks of the screening telephone interview. Children will not be withdrawn from psychotropic medications in order to be enrolled in the study.      
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323947

Locations
United States, Massachusetts
Childrens Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Joseph M. Gonzalez-Heydrich, MD Children's Hospital Boston, Harvard Medical School
  More Information

No publications provided

Responsible Party: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00323947     History of Changes
Other Study ID Numbers: K23 MH066835, K23MH066835, DDTR BK-TKND
Study First Received: May 8, 2006
Last Updated: July 31, 2013
Health Authority: United States: Federal Government

Keywords provided by Children's Hospital Boston:
ADHD
Seizures
Methylphenidate
Stimulant

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Epilepsy
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Brain Diseases
Central Nervous System Diseases
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Methylphenidate
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014