跳至主要内容
临床试验/NCT03296176
NCT03296176Unknown不适用

Metabolomic Study in Huntington's Disease

University Hospital, Angers2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年10月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
2
主要终点
metabolite mass

研究概览

简要总结

The purpose of this project is to study Huntington's disease by metabolomic approach.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For all groups:
  • age between 20 and 70 years
  • signature of the informed consent
  • covered by social security
  • For presymptomatic group:
  • positive genetic test with CAG repeat length ≥ 37 in HTT gene
  • Unified Huntington Disease Rating Scale ≤ 5
  • For symptomatic group:
  • positive genetic test with CAG repeat length ≥ 37 in HTT gene
  • The Unified Huntington's Disease Rating Scale motor score ≥ 6
  • The Total Functional Capacity score ≥ 11

排除标准

  • for all groups:
  • participation in another therapeutic trial (3 months exclusion period)
  • pregnancy and breastfeeding
  • persons deprived of their liberty by judicial or administrative decision

研究组 & 干预措施

presymptomatic

Experimental

干预措施: blood sample (Biological)

symptomatic

Experimental

干预措施: blood sample (Biological)

controls

Other

干预措施: blood sample (Biological)

结局指标

主要结局

metabolite mass

时间窗: at baseline

by chromatography and mass spectrometry

次要结局

未报告次要终点

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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