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临床试验/NCT04534023
NCT04534023进行中(未招募)2 期

A Randomized, Double-blind, Multi-center Clinical Study of the Efficacy of Idebenone in the Treatment of Primary Rapid Eye Movement Sleep Behavior Disorder Into Synucleinopathies

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2020年8月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
进行中(未招募)
入组人数
28
试验地点
1
主要终点
Ineffective

研究概览

简要总结

142 cases of patients with iRBD will be recruited from the neurology department of Ruijin Hospital, th second Affiliated Hospital of Soochow University and wuhan Union Hospital. After the informed consent was signed, they were divided into a trial group and a control group randomly. Each group contains 71 cases. The patients in the trial group will be treated with Idebenone, while the patients in the control group was treated with placebo. Both groups of subjects will be treated for 5 years, and patients will be followed-up and evaluated in the first year, 3 years and 5 years after treatment. The observations include the MDS-UPDRS questionnaires evaluation, blood biomarker measurements and fMRI or PET-MR examination to make sure whether the patients has converted to synucleinopathies. Study hypothesis: Idebenone therapy for patients with iRBD is safe and effective in delaying disease progression into synucleinopathies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosed of iRBD.
  • Age between 40 and
  • Be voluntarily to participate in the experiment by signing an informed consent form.

排除标准

  • Sleep apnea hypopnea syndrome
  • Slow movement, muscle rigidity, tremor or postural instability.
  • Neurological diseases such as cerebral hemorrhage, cerebral infarction, brain trauma, brain tumor or central nervous system infection.
  • Other sleep disorders or seizures.
  • Alcoholism or drug addiction patients.

研究组 & 干预措施

trial group

Experimental

Idebenone

干预措施: Idebenone (Drug)

control group

Placebo Comparator

placebo

干预措施: Placebo (Drug)

结局指标

主要结局

Ineffective

时间窗: 5 years

5-year conversion rate of iRBD patients to synucleinopathies remained unchanged or increased.

Effective

时间窗: 5 years

5-year conversion rate of iRBD patients to synucleinopathies decreased

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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