NCT01397968已完成2 期
A Phase 2 Multicenter, Double-blind, Randomized, Adjunctive, Placebo-controlled Trial With an Open-label Extension to Evaluate the Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 38
- 主要终点
- Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days
研究概览
简要总结
This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully controlled despite their treatment with 1 to 3 concomitant anti-epileptic drugs.
Also to evaluate the safety and tolerability of YKP3089.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of treatment resistant partial epilepsy;
- •History of epilepsy for at least 2 years;
- •Have at least 3 simple partial with motor component, complex partial or secondarily generalized seizures per month with no consecutive 21 day seizure free period.
- •Currently treated on a stable dose of :
- •1 - 3 AED's for at least 12 weeks prior to randomization.
- •VNS will not be counted as AED; however the parameters must remain stable for at least 4 weeks prior to baseline.
- •Benzodiazepines taken at least once per week for epilepsy, or for anxiety or sleep disorder, will be counted as 1 AED. Therefore only a maximum of two additional approved AEDs will be allowed.
排除标准
- •A history of alcoholism, drug abuse, or drug addiction within the past 2 years.
- •Subject has had status epilepticus within past 1 year.
- •Subject has had greater than 2 allergic reactions to an AED or one serious hypersensitivity reaction to an AED.
- •Subjects taking felbamate with less than 18 months continuous exposure.
- •Subjects receiving phenytoin, phenobarbitone or metabolites of these drugs.
- •No active suicidal plan/intent or active suicidal thoughts in the past 6 months.
- •History of suicide attempt in the last 2 years; not more than 1 lifetime suicide attempt.
- •Subject meets criteria for current major depressive episode (within 6 months).
- •Use of intermittent rescue benzodiazepines more than once/month (1-2 doses in a 24-hour period is considered one rescue) in the one month period prior to Visit 1.
研究组 & 干预措施
YKP3089
Experimental
干预措施: YKP3089 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days
时间窗: assessed per 28 days during 12 week period; change from baseline and 12 weeks reported
Percent change in 28-day frequency of simple partial motor, and/or complex partial, and/or secondarily generalized tonic-clonic seizures during the 12 week treatment period relative to baseline
次要结局
- 50% Responder Rate(12 weeks)
研究者
研究点 (38)
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