CompletedPhase 2

A Pilot Study of Topiramate in Childhood Absence Epilepsy

12 participantsStarted 2005-03

Plain-language summary

Limited data exist on the effectiveness of antiepileptic drugs for treatment of childhood absence epilepsy. Preliminary data suggest that topiramate may be an effective drug for this condition. The present study is designed to provide further evidence of the potential effectiveness of topiramate for childhood absence epilepsy, as well as preliminary information about a potential target dose for future study.

Who can participate

Age range4 Years – 9 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Weight of at least 15 kg (33 pounds) * confirmed diagnosis of childhood absence epilepsy * no other serious health problems or neurologic problems * have not taken anti-epilepsy drugs other than ethosuximide, lamotrigine, or valproate * able to take oral medication in a sprinkle capsule formulation * girls must not have gotten their first menstrual period. Exclusion Criteria: * No seizures that are caused by something other than childhood absence epilepsy * not taken topiramate, primidone, zonisamide, or phenobarbital in the past * had to stop taking an anti-epilepsy drug (ethosuximide, lamotrigine, or valproate) because it was not effective in treating childhood absence epilepsy * no presence of abnormal brain waves on electroencephalogram * no presence of mental retardation, no autism, or severe developmental disorder.

What they're measuring

Proportion of subjects who become seizure-free.

Trial details

NCT IDNCT00210574

SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Epilepsy, Absence trials