Status:
COMPLETED
Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures
Lead Sponsor:
UCB Korea Co., Ltd.
Conditions:
Epilepsy
Eligibility:
All Genders
16-80 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
343 Patients enrolled
Trial Details
Trial ID
NCT01229735
Start Date
November 1 2010
End Date
May 1 2015
Last Update
August 15 2017
Active Locations (24)
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14
Busan, South Korea
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Busan, South Korea
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8
Busan, South Korea
4
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Busan, South Korea