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

Completed · Phase 4 · Has a placebo group

Conditions studied: Attention Deficit Disorder With Hyperactivity, Epilepsy

In brief

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.

Key facts

Study ID

NCT00323947

Run by

Boston Children's Hospital

People needed

33

Starts

2003-05-01

Expected to finish

2007-11-01

Last updated by the study team

2013-08-01

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Childrens Hospital Boston — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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