Open Label Safety and Efficacy Study of Levetiracetam in Korean Patients With Epilepsy

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: All

Summary

A Korean open-label, community-based trial assessing the efficacy and safety of levetiracetam as adjunctive therapy in partial epilepsy.

Similarity with a similar study conducted in Caucasian epileptic subjects will be assessed.

• Phase: Phase 3

Details

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

Criteria

Inclusion Criteria:

• Subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized.

• Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit 1.

• Use of one (1), but no more than two (2) concomitant marketed AEDs at the time of trial entry.

Exclusion Criteria:

• Subjects on felbamate with less than 18 months exposure.

• Subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months.

• Presence of known pseudoseizures within the last year.

• Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.

• Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.