Overview

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)