jRCT2080224076已完成3 期
A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Intravenous Brivaracetam as Replaement for Oral Brivaracetam in Japanese Subjects >=16 Years of Age with Partial Seizures With or Without Secondary Generalization
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Adverse Events (AEs) as reported spontaneously by the subject or observed by the Investigator
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Open-label, Multicenter Study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 16age old over 至 No limit（—）
- 性别
- All
入选标准
- •Subject has, in the opinion of the Investigator, adequate seizure control for participation in the study, and is willing and able to comply with all study requirements including hospitalization, multiple blood draws, and intravenous (iv) injection
- •Female subjects without childbearing potential (postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
- •Japanese subject is currently enrolled in EP0085 [NCT03250377] receiving oral brivaracetam (BRV) for the treatment of partial seizures and has been enrolled for at least 8 weeks prior to entry into EP0118
- •Subject has been on a stable twice daily dosage regimen of BRV 50 mg/day to 200 mg/day for the 4 weeks prior to entry into EP0118
- •Subject has been receiving concomitant antiepileptic drug (AED(s)) at doses that have remained stable for the 4 weeks (12 weeks for phenobarbital, phenytoin, and primidone) prior to entry into EP0118
- •Subject has been receiving drugs with possible central nervous system (CNS) effects at doses that have remained stable for the 4 weeks prior to entry into EP0118, if applicable
- •Subject has been receiving drugs that significantly influence the metabolism of BRV at doses that have remained stable for the 4 weeks prior to entry into EP0118, if applicable
- •Subject has had stable vagal nerve stimulation (VNS) settings for the 4 weeks prior to entry into EP0118, if applicable
排除标准
- •Subject is receiving an investigational medicinal product (IMP) or unapproved medication other than oral BRV, or using an experimental medical device
- •Subject has previously been treated with intravenous (iv) brivaracetam (BRV)
- •Subject has a known hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol
- •Subject has a confirmed clinically relevant abnormality by electrocardiogram (ECG)
- •Subject has a severe medical, neurological, or psychiatric disorder, or abnormal laboratory values which may have an impact on the safety of the subject
- •Subject has demonstrated poor compliance with the visit schedule or medication intake in previous BRV studies
- •Subject has planned participation in any other clinical study of another IMP or device during this study
- •Subject is a pregnant or lactating female
- •Subject has any medical condition which, in the Investigator's opinion, warrants exclusion
- •Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) "Since Last Visit" at Screening
- •Subject has >2x upper limit of normal (ULN) of any of the following prior to Day 1 (from liver function assessment in EP0085): alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (>=1.5x ULN total bilirubin if known Gilbert's syndrome)tion (VNS) settings for the 4 weeks prior to entry into EP0118, if applicable
结局指标
主要结局
Adverse Events (AEs) as reported spontaneously by the subject or observed by the Investigator
Adverse Events (AEs) as reported spontaneously by the subject or observed by the Investigator
Subject withdrawal due to Adverse Events (AEs)
Subject withdrawal due to Adverse Events (AEs)
Occurrence of Serious Adverse Events (SAEs)
Occurrence of Serious Adverse Events (SAEs)
次要结局
未报告次要终点
研究者
研究点 (1)
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