JPRN-jRCT2071210015已完成2 期
A Dose-Blind Extension Study With Double-blind, Placebo-Controlled, Randomized Withdrawal Period to Evaluate the Safety and Explore the Pharmacokinetics and Pharmacodynamics of TAK-994 in Adults With Narcolepsy With Cataplexy (Narcolepsy Type 1)
onomura Hidenori0 个研究点目标入组 26 人开始时间: 2021年4月28日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
研究概览
简要总结
A safety signal for DILI emerged in the phase 2 studies of TAK-994; therefore, Takeda decided to suspend dosing immediately and prematurely discontinued the studies to allow for timely interpretation of the benefit-risk profile of TAK-994.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 65age old（—）
- 性别
- All
入选标准
- •1. Participant with a diagnosis of Narcolepsy Type 1 (NT1) who has completed TAK-994-1501 Part B before enrollment (which will occur immediately following the final TAK-994-1501 assessments), and for whom the investigator has no clinical objection they be enrolled.
排除标准
- •1. Participant has a clinically significant moderate or severe ongoing adverse event (AE) related to the study drug from the prior study.
研究者
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