Creatine Safety & Tolerability in Huntington's Disease (CREST-X): A Single-Center, Open-Label, Long-Term Safety & Tolerability Extension Study of Creatine in Subjects With HD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Tolerability
研究概览
简要总结
The purpose of this study is to extend findings from the creatine dose-finding study (CREST-UP1) in Huntington's disease to evaluate the long-term safety, tolerability, and clinical impact of high dose creatine.
详细描述
PRÉCIS Protocol Title Creatine Safety & Tolerability in Huntington's Disease (CREST-X): A Single-Center, Open-Label, Long-Term Safety & Tolerability Extension Study of Creatine in Subjects with HD
Study Phase Phase II Clinical Trial
Funding Departmental Funds
Drug Supply Provided By The Avicena Group, Inc (Palo Alto, CA)
Number of Subjects Up to 10 subjects enrolling from the creatine dose-finding study CREST-UP1 (PHRC Protocol: 2004-P-000925)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who have completed the CREST-UP1 study.
- •Individuals who are able to take oral medication.
- •Individuals capable of providing informed consent and complying with trial procedures.
排除标准
- •History of known sensitivity or intolerability to creatine.
- •Clinical evidence of unstable medical illness in the investigator's judgment.
- •Additional eligibility criteria apply.
研究组 & 干预措施
Creatine monohydrate
single arm long-term open label follow-up
干预措施: Creatine monohydrate (Drug)
结局指标
主要结局
Tolerability
时间窗: 306 Weeks
Proportion of subjects able to complete treatment
次要结局
- Biological Markers of Disease Progression(310 Weeks)
- Clinical Measures Resources Not Available to Complete Secondary Analyses.(310 Weeks)
研究者
Steven M. Hersch
Professor of Neurology
Massachusetts General Hospital