Status:
COMPLETED
Methylphenidate for Treating Attention Deficit Hyperactivity Disorder in Children With Both ADHD and Epilepsy
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Attention Deficit Disorder With Hyperactivity
Epilepsy
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00323947
Start Date
May 1 2003
End Date
November 1 2007
Last Update
August 1 2013
Active Locations (1)
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1
Childrens Hospital Boston
Boston, Massachusetts, United States, 02115