A Study of the Effectiveness and Safety of Topiramate Monotherapy in Patients With Recently Diagnosed Partial-Onset Seizure

• Status: Completed
• Trial end date: 2002-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purposes of this study are (1) to compare the effectiveness of two doses of topiramate and (2) to assess the safety of topiramate alone in the treatment of pediatric and adult patients with recently diagnosed epilepsy characterized by partial-onset seizures.

• 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 between 25 kg and 110 kg (approximately 55-240 lb)

• Diagnosis of epilepsy characterized by unprovoked partial-onset seizures that were diagnosed within the past three years

• During the three-month Retrospective Baseline Phase, patients must have had at least one seizure, have had an average of no more than two seizures per month, and have had no more than three seizures in any given month. None of the seizures should occur in a cluster pattern

• During the three-month Retrospective Baseline Phase, patients must receive either no other standard Anti-Epileptic Drug (AED), or be on one AED

• Patients currently on one AED must be considered inadequately controlled

• Must have evidence from computed tomography (CT) or magnetic resonance imaging (MRI) of the absence of an arteriovenous malformation or a progressive lesion such as a tumor.

Exclusion Criteria:

• Patients who do not have epilepsy, such as patients with pseudoseizures or a treatable cause of seizures

• Patients with benign rolandic epilepsy

• Patients with progressive or degenerative disorders

• Patients with a documented history of generalized tonic-clonic status epilepticus during the three month Retrospective Baseline Phase

• Patients with a significant history (within the past two years) of medical disease that may impair their reliable participation in the trial or necessitate the use of medication not allowed by this protocol

• Patients who are unable to take their medication either independently or with assistance.