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

• Status: Completed
• Trial end date: 1997-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness and safety of topiramate (an antiepileptic medication) in patients with epilepsy.

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

Details

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

Criteria

Inclusion Criteria:

• Body weight >90 pounds

• documented history of frequent partial onset seizures

• at least four partial onset seizures per month while taking a constant antiepileptic drug dosage during the screening period

• a recent history of maintenance on 1 or 2 standard antiepileptic drugs

• females must be postmenopausal for at least 1 year, or if of childbearing age, be sexually abstinent, surgically sterile, or using adequate birth control measures, and have a negative pregnancy test before study entry.

Exclusion Criteria:

• Patients who do not have epilepsy, such as patients with treatable causes of seizure (for example, cancer or active infection)

• have a documented history (previous 3 months) of generalized status epilepticus while receiving anticonvulsant medication (status epilepticus is a prolonged seizure or seizures repeated frequently over 20 to 30 minutes so that recovery between episodes does not occur)

• have seizures occurring in only clustered patterns (numerous seizures over a short period of time)

• a significant history (within 2 years) of medical disease (heart, kidney, hormone, gynecologic, muscle, bone, gastrointestinal, metabolic, liver diseases or cancer with a metastatic potential)

• history of alcohol or drug abuse history within the past 1 year.