EUCTR2014-005112-42-NL进行中（未招募）1 期
A comparative phase2 study assessing the efficacy of triheptanoin, an anaplerotic therapy in Huntington's Disease (TRIHEP 3)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- INSERM
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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
- •Covered by social security
- •UHDRS score between 5 and 40
- •Ability to undergo MRI scanning
- •BMI between 18 and 30
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Treatment with sodium valproate
- •Treatment with tetrabenazine
- •Treatment with inhibitors of pancreatic lipases (e.g. orlistat)
- •Hypersensitivity to triheptanoin or to one of its excipients
- •Additional major comorbidities
- •History of severe head injury
- •Participation in another therapeutic trial (3 month 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
- •Inability to understand information about the protocol
- •Persons deprived of their liberty by judicial or administrative decision
- •Adult subject under legal protection or unable to consent
研究者
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