A Study of the Effectiveness and Safety of Topiramate in the Treatment of Children With Epilepsy

• Status: Completed
• Trial end date: 2000-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and effectiveness of oral topiramate as add-on therapy in children with uncontrolled partial onset seizures who are taking one or two standard anti-epileptic drugs.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• Patients must weigh at least 36 pounds (16 kilograms)

• patients must have partial onset seizures (with or without secondarily generalized seizures) being treated with at least one, but no more than two antiepileptic drugs (AEDs)

• patients must have at least 6 partial onset seizures during the 8-week baseline phase, with at least one seizure during each 4-week period

• an electroencephalogram (EEG) with features consistent with partial epilepsy performed prior to study initiation or during the baseline phase

Exclusion Criteria:

• Females who are pregnant, nursing, or those not using adequate birth control if capable of having children

• patients with a treatable cause of seizures (for example, infections)

• patients with a progressive disorder of the nervous system

• patients with a clinical diagnosis of Lennox-Gastaut syndrome

• patients with a history of generalized status epilepticus (repeated or prolonged seizures) while on appropriate anti-epileptic therapy