A Study on Safety and Efficacy of Two Doses of Topiramate as Monotherapy in the Treatment of Newly Diagnosed or Recurrent Epilepsy

• Status: Completed
• Trial end date: 2003-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the safety and effectiveness of two doses of topiramate as monotherapy in the treatment of pediatric and adult patients with newly diagnosed or recurrent epilepsy.

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

Details

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

Criteria

Inclusion Criteria:

• Weigh >=25 kilograms

• Diagnosis of epilepsy within 3 months prior to study entry or recurrence of epilepsy while off of anit-epileptic drugs

• No more than two documented seizures during the three-month retrospective baseline phase

• may have experienced seizures prior to the three-month, retrospective baseline phase

• Patients with partial-onset seizures, with or without a secondarily generalized component, and generalized seizures, including tonic-clonic (grand mal), tonic, clonic, juvenile myoclonic epilepsy (impulsive petit mal) and myoclonic epilepsy

• Receiving either no other concomitant anti-epileptic drug (AED) or be on one standard AED.

Exclusion Criteria:

• Patients who do not have epilepsy

• Patients with absence (petit mal) or atypical absence seizures, epilepsia paritlis continua, cluster pattern or serial seizures

• Patients with progressive neurological or degenerative disorder

• Patients with significant history of unstable medical diseases

• Patients with a drug allergy or hypersensitivity to carbonic anhydrase inhibitors or sulfa drugs

• Patients with history of alcohol or drug abuse within past one year

• Patients with a history of suicide attempt within past one year.