A Study of the Effectiveness and Safety of Topiramate Compared With a Standard Therapy in Patients Newly Diagnosed With Epilepsy

• Status: Completed
• Trial end date: 2000-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effectiveness and safety of topiramate to standard antiepileptic drugs in children and adults with newly diagnosed epilepsy.

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

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Carbamazepine; Topiramate; Valproic Acid

Criteria

Inclusion Criteria:

• Body weight of at least 30 kilograms

• New epilepsy diagnosis and at least one unprovoked seizure within 3 months before study entry

• No history of antiepileptic drug use or taking a single antiepileptic drug for no longer than 6 weeks

• Females must 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

• Have progressive or degenerative disorders (for example, certain hereditary conditions)

• Have a significant history (within last 2 years) of unstable medical diseases (heart, kidney, hormone, or liver diseases)

• Have mental retardation or other condition that could make interpretation of the study results difficult

• alcohol or drug abuse within the previous year