A Randomized, Open-label, Parallel Group, Multi-center, Comparative, Phase IV Trial of Levetiracetam (LEV) Versus Topiramate (TPM) as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures

CB Korea Co.,Ltd.0 个研究点目标入组 340 人开始时间: 2015年10月27日最近更新: 2015年11月16日

试验速览

暂无简介。

•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 Visit 1 according to ILAE classification
•Subjects having at least 1 partial onset seizures whether or not secondarily generalized per 4 weeks preceding Visit 2 according to ILAE classification
•Subjects with each interval of partial onset seizures less than 6 weeks during entire 12 weeks (8 weeks preceding Visit 1 and 4 weeks preceding Visit 2)
•Subjects being uncontrolled while treated by 1 to 3 permitted concomitant antiepileptic drugs (AEDs)
•Permitted concomitant AEDs having been stable and at optimal dosage for the subject from at least 4 week before Visit 1 and during 4 weeks preceding Visit 2 and expected to be kept stable during the Treatment Period
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 10
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•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 Visit 2
•Presence of exclusively type IA non-motor seizures
•History or presence of status epilepticus within last 3 months preceding Visit 1 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)

发起方

CB Korea Co.,Ltd.