NCT02239380已完成3 期
A Multi-center, Open-label, Non-controlled Study To Evaluate The Efficacy And Safety Of Lorazepam Intravenously Administered In Subjects With Status Epilepticus Or Repetitive Status Epilepticus
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 26
- 试验地点
- 20
- 主要终点
- Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Initial Dose (Dose 1) of Study Drug
研究概览
简要总结
The purpose of this study is to determine the efficacy, safety and pharmacokinetics of Lorazepam on Japanese patients with Status Epilepticus or Repetitive Status Eplilepticus.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with status epilepticus or repetitive status epilepticus / cluster seizure who have seizures that can be evaluated by investigator's visual observations based on motor symptoms or who have seizures that can be evaluated by EEG.
- •Subjects with status epilepticus accompanied by generalized seizure, partial seizure or secondarily generalized seizure lasting 5 minutes or longer
- •Subjects with repetitive status epilepticus / cluster seizure accompanied by not less than 3 consecutive episodes of generalized seizure, partial seizure or secondarily generalized seizure in 1 hour.
- •Subjects not younger than 3 months (either gender is eligible for the study)
排除标准
- •Subjects with known or suspected recurrent seizures due to illegal drug or alcohol withdrawal
- •Subjects with known history of hypersensitivity to lorazepam or benzodiazepine
- •Subjects with a known history of benzodiazepine abuse.
- •Subjects currently receiving lorazepam
- •Subjects with angle-closure glaucoma
- •Subjects with myasthenia gravis
- •Subjects with either of aspartate transaminase, alanine transaminase, total bilirubin, blood urea nitrogen, or creatinine at screening visit exceeding 2x the upper limit of normal of the institutional reference value (if the data is available)
- •Subjects with white blood cell count less than 3000/mm3 or neutrophil count less than 1500/mm3 at screening visit (if the data is available)
研究组 & 干预措施
Lorazepam
Experimental
Lorazepam intravenous formulation
干预措施: Lorazepam (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Initial Dose (Dose 1) of Study Drug
时间窗: 30 minutes post Dose 1
Participants with clinical benefit were defined as participants whose initial seizure stopped within 10 minutes after initial dose (Dose 1) and who continued seizure-free for at least 30 minutes after the completion of initial dose (Dose 1).
次要结局
- Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Any Dose of Study Drug(30 minutes post Dose 1 or 2)
- Percentage of Participants Who Achieved Seizure Free Interval of At Least 12 Hours After Administration (Either Initial or Any Dose) of Study Drug(12 hour post Dose 1; 12 hour post Dose 1 or 2)
- Percentage of Participants Who Achieved Seizure Free Interval of At Least 24 Hours After Administration (Either Initial or Any Dose) of Study Drug(24 hour post Dose 1; 24 hour post Dose 1 or 2)
- Time to Resolution of Seizures From The Administration (Either Initial or Any Dose) of Study Drug(10 minutes post Dose 1; 10 minutes post Dose 1 or 2)
- Time to Relapse Following The Administration (Either Initial or Any Dose) of Study Drug(24 hour post Dose 1; 24 hour post Dose 1 or 2)
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to 7 days after last dose of study drug administration (up to 12 days))
研究者
研究点 (20)
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