A Study of the Efficacy and Safety of Topiramate in the Treatment of Patients With Difficult to Control Epilepsy

• Status: Completed
• Trial end date: 1990-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

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

Criteria

Inclusion Criteria:

• History of simple or complex partial epilepsy that has been documented or witnessed

• during a 12-week baseline phase, patient must have at least 12 partial seizures while maintaining therapeutic levels of antiepileptic drugs (AEDs)

• and have no more than one seizure-free interval of up to 3 weeks and none longer than 3 weeks

• good physical health.

Exclusion Criteria:

• Patients having solely generalized seizures or lacking documentation of partial epilepsy

• patients with generalized tonic-clonic seizures or other generalized epilepsies in the absence of an EEG consistent with partial epilepsy

• generalized seizures, which are defined by the EEG wave pattern

• seizures that lack an abnormal pulsation pattern on EEG

• females who are capable of having children