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A Pilot Study of Topiramate in Childhood Absence Epilepsy

Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

About this trial

Last updated 14 years ago

Study ID

CR002872

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
4 to 9 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 19 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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.