CTRI/2012/03/002500招募中2 期
A phase 2, multicenter, double-blind, randomized, adjunctive placebo-controlled trial to evaluate the efficacy and safety of YKP3089 in subjects with treatment resistant partial onset seizures
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) Male or female subjects age 18-65 years inclusive
- •2) Subjects in otherwise good health (with the
- •exception of epilepsy), as determined by the PI
- •via the medical history, a physical examination
- •and screening laboratory investigations.
- •3) A diagnosis of treatment resistant partial epilepsy
- •4) History of epilepsy for at least 2 years.
- •5) 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.
- •6) Currently treated on a stable dose of :
- •1 â?? 3 AEDâ??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
- •1.A history of alcoholism, drug abuse, or drug addiction within the past 2 years.
- •2.Subject has had status epilepticus within past 1 year.
- •3.Subject has had greater than 2 allergic reactions to an AED or one serious hypersensitivity reaction to an AED.
- •4.Subjects taking felbamate with less than 18 months continuous exposure.
- •5.Subjects receiving phenytoin, phenobarbitone or metabolites of these drugs.
- •6.No active suicidal plan/intent or active suicidal thoughts in the past 6 months.
- •7.History of suicide attempt in the last 2 years; not more than 1 lifetime suicide attempt.
- •8.Subject meets criteria for current major depressive episode (within 6 months).
- •9.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.
研究者
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