Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the long-term effects of levetiracetam on retention rate in subjects with refractory partial onset seizure that are not fully controlled with 1 to 3 concomitant antiepileptic drugs, compared to topiramate as add-on therapy during 52 weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Korea Co., Ltd.
• Treatments: Etiracetam; Levetiracetam; Piracetam; Topiramate

Criteria

Inclusion Criteria:

• Male or female subjects from 16 to 80 years, inclusive. Subjects under 20 years may only be included where legally permitted and ethically accepted

• Subjects with refractory epilepsy with partial onset seizure classifiable according to the International League Against Epilepsy (ILAE).

• Subjects having at least 2 partial onset seizures whether or not secondarily generalized during the 8 weeks historical baseline preceding V1 according to ILAE classification

• Subjects having at least 1 partial onset seizures whether or not secondarily generalized per 4 weeks preceding V2 according to ILAE classification

• Subjects with each interval of partial onset seizures less than 6 weeks during entire 12 weeks (8 weeks preceding V1 and 4 weeks preceding V2)

• Subjects being uncontrolled while treated by 1 to 3 permitted concomitant AEDs.

• Permitted concomitant AEDs having been stable and at optimal dosage for the subject from at least 4 week before V1 and during 4 weeks preceding V2 and expected to be kept stable during the Treatment Period.

Exclusion Criteria:

• Subjects presenting any generalized epilepsies classified as type II according to the ILAE classification (ref to publication from 1981)

• Subjects suffering from epilepsies and syndromes undetermined whether focal or generalized (classification III according to the ILAE classification)

• Subjects suffering from special syndromes (classification IV according to the ILAE classification)

• History or occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before V2.

• Presence of exclusively type IA non-motor seizures.

• History or presence of status epilepticus within last 3 months preceding V1 or during Baseline

• History or presence of known pseudo-seizures

• Subjects who are currently on vigabatrin. (Subjects who received vigabatrin in the past and have a normal visual field test are allowed.)

• Subject taking 1 or more of the following medications on a regular basis within 28 days prior to Visit 1: antipsychotics drugs, and psychostimulant (amphetamine derivatives)