A Clinical Study of the Efficacy of Idebenone in the Treatment of iRBD Into Synucleinopathies

NCT04534023 · tracked via the Priya Life Science China tracker

Sponsor

Ruijin Hospital

Phase

Phase 2

Started

2020-08-31

Last updated

2025-11-25

Condition(s) studied

Rapid Eye Movement Sleep Behavior DisorderSynucleinopathy

Investigational drug(s) / intervention(s)

IdebenonePlacebo

Idebenone: trial group

Placebo: control group

Study summary

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.

Eligibility

Sex

ALL

Min age

40 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. Clinical diagnosed of iRBD. 2. Age between 40 and 75. 3. Be voluntarily to participate in the experiment by signing an informed consent form. Exclusion Criteria: 1. Sleep apnea hypopnea syndrome 2. Slow movement, muscle rigidity, tremor or postural instability. 3. Neurological diseases such as cerebral hemorrhage, cerebral infarction, brain trauma, brain tumor or central nervous system infection. 4. Other sleep disorders or seizures. 5. Alcoholism or drug addiction patients.

Primary outcome measure(s)

Effective — 5 years
5-year conversion rate of iRBD patients to synucleinopathies decreased
Ineffective — 5 years
5-year conversion rate of iRBD patients to synucleinopathies remained unchanged or increased.

Trial sites (1)

Facility	City	Region	Status
Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04534023 on ClinicalTrials.gov ↗ ← All trials in China