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

UCB

Status and phase: Completed; Phase 3

Conditions: Epilepsy, Partial

Treatments: Drug: Levetiracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00160628

N01099

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.