Overview

A Study of the Efficacy and Safety of Topiramate in the Treatment of Patients With Epilepsy.

Status:
Completed
Trial end date:
1993-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the effectiveness and safety of topiramate as an add-on therapy in patients with uncontrolled 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

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