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

November 20, 2025 updated by: Ruijin Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control group
placebo
Drug: Placebo
control group
Experimental: trial group
Idebenone
Drug: Idebenone
trial group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective
Time Frame: 5 years
5-year conversion rate of iRBD patients to synucleinopathies decreased
5 years
Ineffective
Time Frame: 5 years
5-year conversion rate of iRBD patients to synucleinopathies remained unchanged or increased.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Collaborators

Second Affiliated Hospital of Soochow University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2020

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

September 1, 2020

Study Record Updates

Last Update Posted (Estimated)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ruijinlj

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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