NCT07197866招募中2 期
An Open-Label Extension, Multi-Centered, Phase 2 Trial to Describe the Safety and Efficacy of TEV-56286 (Emrusolmin) in Participants With Multiple System Atrophy
Teva Branded Pharmaceutical Products R&D LLC36 个研究点 分布在 7 个国家目标入组 200 人开始时间: 2025年9月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 36
- 主要终点
- Number of participants experiencing an adverse event
研究概览
简要总结
The primary objective of the trial is to describe the long-term safety and tolerability of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA).
A secondary objective of the trial is to further describe the safety and tolerability of TEV-56286.
The planned total duration of the trial is approximately 100 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of the treatment period and the week 48(V9) visit of the double-blind trial (TV56286-NDG-20039) whilst remaining compliant with trial requirements
- •Females of childbearing potential may be included only if they have a negative pregnancy test at the baseline visit
- •Females of childbearing potential whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the trial and for 28 days after the last does of IMP
- •Males who are potentially fertile/reproductively competent (not surgically [eg, vasectomy] or congenitally sterile) and their female partners who are of childbearing potential must use, together with their female partners, highly effective birth control methods for the duration of the trial and for 28 days after the last dose of investigational medicinal product
- •NOTE - Additional criteria apply, please contact the investigator for more information
排除标准
- •Is a female participant who is pregnant, plans to become pregnant, or is breastfeeding during the trial
- •Is of a vulnerable population (eg, people kept in detention or jail)
- •Is using or consuming any prohibited concomitant medications within the specified exclusionary windows of this trial
- •Note - Additional criteria apply, please contact the investigator for more information
研究组 & 干预措施
TEV-56286
Experimental
干预措施: TEV-56286 (Drug)
结局指标
主要结局
Number of participants experiencing an adverse event
时间窗: Baseline to Week 100
Number of participants who withdrew from the trial due to an adverse event
时间窗: Baseline to Week 100
次要结局
- Number of participants with potentially clinically significant vital sign values(Baseline to Week 96)
- Number of participants with potentially clinically significant laboratory test values (hematology and chemistry)(Baseline to Week 96)
- Number of participants with potentially clinically significant 12-lead ECG measurements(Baseline to Week 96)
研究者
研究点 (36)
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