EUCTR2014-005112-42-FR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
- 50
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 lenght = 39 in HTT gene
- •- at lmeast 18 years of age
- •- signature of informed consent
- •- covered by social security
- •- UHDRS score between 5 and 40
- •- Ability to undergo MRI scanning
- •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
- •- Hypersensitivity to triheptanoin or to one of its excipients
- •- additional psychiatric or neurological conditions
- •- severe head injury
- •- Participation in another therapeutical trial ( 3 months exclusion period)
- •- Pregnancy or breastfeeding
- •- Inability 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
- •- Patients under tetrabenazine and neuroleptics other than atypical neuroleptics at a small dose
研究者
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