A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.

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

Details

• Lead Sponsor: UCB Pharma
• Treatments: Etiracetam; Levetiracetam

Criteria

Inclusion Criteria:

• Patients with a confirmed diagnosis of refractory epilepsy

• Patients must be receiving a stable dose of 1 - 3 concomitant Anti-Epileptic Drugs (AED)

• Female patients without childbearing potential. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method

Exclusion Criteria:

• Seizures occurring in clusters

• Status epilepticus within 3 months of Visit 1

• History of non-epileptic seizures

• Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients

• Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control