NCT01498822已完成4 期
A Multi-Center, Open-label, Randomized Study to Evaluate the Long Term Effectiveness of Levetiracetam as Monotherapy in Comparison With Oxcarbazepine in Subjects With Newly or Recently Diagnosed Partial Epilepsy
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
- 353
- 试验地点
- 23
- 主要终点
- Percentage of Subjects With a Treatment Failure
研究概览
简要总结
To evaluate the long term effectiveness of Levetiracetam (LEV) monotherapy on Treatment Failure Rate in subjects with newly diagnosed partial onset seizures with or without secondary generalized seizures, compared to Oxcarbazepine (OXC) monotherapy over 50 weeks from the first dose
详细描述
The study duration consists of the following periods:
- Baseline period of one week: Week -1
- Titration period of two weeks: Week 0 to Week 1
- Treatment period of 48 weeks: Week 2 to Week 50
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. Vulnerable subjects (e.g., under 20 years or subject with learning disability but judged to be capable to understand) may only be included where legally permitted and ethically accepted
- •Subjects with newly or recently diagnosed epilepsy having experienced unprovoked partial seizures (IA, IB, IC with clear focal origin), that are classifiable according to the International Classification of Epileptic seizure (1981). Undiscriminated subjects between IC and IIE could be included
- •Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year preceding randomization out of which at least 1 unprovoked seizure in the 6 months preceding randomization
- •Subjects with documented evidence of EEG and brain MRI or CT scan in medical records which were performed within 1 year prior to Visit 1 (V1)
- •Subjects have no treatment with anti-epileptic drugs in the 6 months preceding this study. The treatment for acute seizure control is acceptable with a maximum of 2 weeks duration and if the treatment was stopped at least 1 week before V
- •For Phenobarbital and Phenobarbital derivatives, a minimum of 4 weeks wash-out is requested before V1
排除标准
- •Subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or other non-epileptic ictal events which could be confused with seizures
- •Subject taking 1 or more of the following medications on a regular basis within 28 days prior to Visit 1: neuroleptics, monoamine oxidase (MAO) inhibitors and narcotic analgesics
- •Subject taking any immunosuppressant within 28 days prior to Visit 1
- •Subject has a history of suicide attempt, has received professional counseling for suicidal ideation, or is currently experiencing active suicidal ideation
- •Subject has a seizure disorder characterized primarily by isolated auras (ie, simple partial seizures without observable motor signs)
- •Subject suffering from seizures other than partial (IA, IB, IC, with clear focal origin) seizures
- •Subject has a history of status epilepticus within last 3-month period prior to Visit 1
- •Subject has seizures that are uncountable due to clustering (ie, an episode lasting less than 30 minutes in which several seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished) during the 12-week period prior to Visit 1 and/or during the Screening Period
- •Body weight is lower than 40 kg (< 40 kg)
研究组 & 干预措施
Levetiracetam
Experimental
Levetiracetam twice a day treatment group
干预措施: Levetiracetam (Drug)
Oxcarbazepine
Active Comparator
Oxcarbazepine twice a day treatment group
干预措施: Oxcarbazepine (Drug)
结局指标
主要结局
Percentage of Subjects With a Treatment Failure
时间窗: Week 0 (First Dose) to Week 50
Treatment failure is defined as (1) Dropout due to related intolerable adverse event, lack of efficacy or need for addition of another Antiepileptic Drug (AED), or (2) need of a 1-step down-Titration, within 50 weeks from the first dose of study medication.
次要结局
- Percentage of Subjects Who Achieved Seizure Freedom for 24 Consecutive Weeks During the 48 Weeks Treatment Period at Any Time(From Week 2 to Week 50 (During Treatment Period ))
- Percentage of Subjects Who Achieved Seizure Freedom During the 48 Weeks Treatment Period(From Week 2 to Week 50 (During Treatment Period ))
- Time to the First Seizure Defined as the Time From the First Dose of Medication to the Occurrence of the First Seizure During the 48 Weeks Treatment Period(From Week 2 to Week 50 (During Treatment Period ))
研究者
研究点 (23)
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