A Phase 2 interventional study of Idebenone and Placebo in Rapid Eye Movement Sleep Behavior Disorder and Synucleinopathy, sponsored by Ruijin Hospital. Active, not recruiting at 1 site in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by Ruijin Hospital · Phase 2, Interventional, and Treatment
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.
101 studies on the registry are indexed under REM Sleep Behavior Disorder; 45 are open to participants now.
This study's enrollment of 28 is below the median of 42 across 50 interventional studies indexed under REM Sleep Behavior Disorder.
Browse REM Sleep Behavior Disorder studies →Ruijin Hospital is the lead sponsor of 679 studies on the registry; 387 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Idebenone
Drug: Idebenone
placebo
Drug: Placebo
trial group
control group
Effective
5-year conversion rate of iRBD patients to synucleinopathies decreased
Time frame: 5 years
Ineffective
5-year conversion rate of iRBD patients to synucleinopathies remained unchanged or increased.
Time frame: 5 years
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Idebenone