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: 1990-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of topiramate as add-on therapy in patients with difficult to control 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

• during a 12-week baseline phase, patient must have at least 12 partial seizures while maintaining therapeutic levels of anti-epileptic 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:

• Females who are capable of having children

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

• patients with a progressive disorder of the nervous system

• patients with history of status epilepticus (repeated or prolonged seizures) while on antiepileptic therapy

• history of serious disease of the heart, liver, kidneys, gastrointestinal, metabolic, or endocrine system

• history of alcohol or drug abuse within one year prior to study initiation.