A Pilot Study of Topiramate in Childhood Absence Epilepsy

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Ortho-McNeil Neurologics, Inc.
• Treatments: Topiramate

Criteria

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.