NL-OMON43815已完成2 期
A comparative phase2 study assessing the efficacy of triheptanoin, an anaplerotic therapy in Huntington's Disease (HD) - TRIHEP 3 in HD
The French National Institute of Health and Medical Research (Inserm)0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- positive genetic test with CAG repeat length * 39 in HTT gene
- •- at least 18 years of age
- •- signature of informed consent
- •- UHDRS score between 5 and 40
- •- Ability to undergo MRI scanning
排除标准
- •- hypersensitivity to triheptanoin or to one of its excipients
- •- additional psychiatric or neurological conditions
- •- severe head injury
- •- farticipation in another therapeutical trial ( 3 months exclusion period)
- •- for women of childbearing age, the absence of two forms of effective contraception (with the exception of those who are abstinent)
- •- for men, the absence of an effective form of contraception (e.g. a condom) throughout the study period
- •- pregnancy or breastfeeding
- •- pnability to understand information about the protocol
- •- persons deprived of their liberty by judicial or unable to consent
- •- adult subject under legal protection or unable to consent
- •- treatment with tetrabenazine, sodium valporate, and pancreatic inhibitors
研究者
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