A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures.

• Status: Completed
• Trial end date: 1993-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the efficacy and safety of topiramate in epilepsy patients with difficult to treat, partial-onset seizures who are taking one or two standard antiepileptic 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

• an electroencephalogram (EEG) during the preceding 5 years that has a pattern consistent with the diagnosis of partial epilepsy

• during an 8-week baseline phase, patient must have at least 8 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 no seizure-free interval 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

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