JPRN-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
CB Japan Co., Ltd.0 个研究点目标入组 10 人开始时间: 2018年10月3日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
The results of this open-label study evaluating the safety and tolerability of iv BRV as adjunctive therapy administered as short-term replacement for oral BRV in adult Japanese study participants with POS with or without secondary generalization suggest that at doses ranging from 50 to 200mg/day, iv BRV was safe and generally well tolerated. Results of this study show that iv BRV can be used as a short-term replacement for oral BRV in study participants with POS with or without secondary generalization.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 16age old 至 ot applicable（—）
- 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
研究者
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