NCT01229735已完成4 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 343
- 试验地点
- 24
- 主要终点
- Percentage of Subjects Continuing the Allocated Investigational Treatment From the First Study Treatment Intake to Week 52, After the Beginning of Investigational Treatment With Levetiracetam Compared to Topiramate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 V
- •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)
研究组 & 干预措施
Levetiracetam
Experimental
250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
干预措施: Levetiracetam (Drug)
Topiramate
Active Comparator
25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
干预措施: Topiramate (Drug)
结局指标
主要结局
Percentage of Subjects Continuing the Allocated Investigational Treatment From the First Study Treatment Intake to Week 52, After the Beginning of Investigational Treatment With Levetiracetam Compared to Topiramate
时间窗: From Baseline to Week 52
次要结局
- Number of Subjects With at Least One Adverse Event Reported During the Trial Period From Baseline to Week 52(From Baseline to Week 52)
- Time From the First Study Treatment Intake to Drug Discontinuation Due to Adverse Event (AE)(From Baseline to Week 52)
- Median Percent Reduction in the Weekly Partial Onset Seizure (POS) Frequency From Baseline During the Total Treatment Period From Baseline to Week 52(From Baseline to Week 52)
- Responders Defined as Number of Subjects With at Least 50 % Reduction in the Weekly POS Frequency From Baseline During the Total Treatment Period From Baseline to Week 52(From Baseline to Week 52)
研究者
研究点 (24)
Loading locations...
相似试验
Unknown
不适用
Evaluate Retention Rate of Topiramate, Levetiracetam and Oxcarbazepine in a Long-term Epilepsy TreatmentEpilepsyNCT02098941Seoul National University Hospital2,500
已完成
3 期
Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.Epilepsy, Tonic-clonicNCT00150813UCB Pharma SA66
已完成
4 期
Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subjects With Newly or Recently Diagnosed Partial EpilepsyEpilepsyNCT01498822Korea UCB Co., Ltd.353
已完成
不适用
Levetiracetam Versus Valproate in Idiopathic Generalized EpilepsyTreatment of Idiopathic Generalized EpilepsyNCT06393309Mazandaran University of Medical Sciences169
已完成
不适用
An Observational Study to Evaluate Long-term Retention Rate of Topiramate in Participants With EpilepsyEpilepsyNCT01682681Janssen Korea, Ltd., Korea1,234