Bridging Study of L059 (Levetiracetam) in Patients With Epilepsy by Double Blind Method

UCB

Status and phase

Completed

Phase 2

Conditions

Epilepsy

Treatments

Drug: Levetiracetam

Study type

Interventional

Funder types

Industry

Identifiers

NCT00600509

N165

Details and patient eligibility

About

Double-blind, randomized, placebo-controlled, multi center trial to evaluate the efficacy and safety of levetiracetam as adjunctive treatment in adult Japanese epileptic subjects with partial onset seizures.

Enrollment

216 patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

simple and/or complex partial seizures with or without secondary generalization, and first partial seizure >= 2 years before selection visit;
seizures classifiable according to the ILAE classification;
minimum of 12 partial seizures per 12 weeks with a minimum of two partial seizures per 4 weeks from the selection visit to the end of the baseline period ;
exposed to two or more standard AEDs;
taking up to three of the standard AEDs, at the initiation of the trial.

Exclusion criteria

medication influencing the CNS, except for medication taken for antiepileptic treatment;
partial seizures uncountable due to clustering, including status epileptics, during the 3 months prior to the selection visit;
history of cerebrovascular disease including transient ischemic attack (TIA) and progressive cerebral disorder or progressive neurological disorder;
presence or history of any clinically significant allergic condition and complication or history of significant alcohol abuse or drug abuse in the past.