CClinicalTrials.gg
Sign In
Active, not recruitingNCT04534023Updated Nov 25, 2025

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

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

Phase
Phase 2
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

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.

02

Conditions studied

  • Rapid Eye Movement Sleep Behavior Disorder
  • Synucleinopathy
03

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    trial group

    Idebenone

    Drug: Idebenone

  • Placebo comparator
    control group

    placebo

    Drug: Placebo

Interventions

  • DrugIdebenone

    trial group

  • DrugPlacebo

    control group

05

What researchers measure

Primary outcomes

  1. Effective

    5-year conversion rate of iRBD patients to synucleinopathies decreased

    Time frame: 5 years

  2. Ineffective

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

    Time frame: 5 years

06

Study locations

1 site
  • Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai Municipality 200025, China
07

References and documents

Publications

  • Li Y, Wang C, Luo N, Chen F, Zhou L, Niu M, Kang W, Liu J. Efficacy of idebenone in the Treatment of iRBD into Synucleinopathies (EITRS): rationale, design, and methodology of a randomized, double-blind, multi-center clinical study. Front Neurol. 2022 Sep 12;13:981249. doi: 10.3389/fneur.2022.981249. eCollection 2022. PubMed 36172027 ↗
08

Registry details

Key details

Study ID
NCT04534023
Lead sponsor
Ruijin Hospital
Collaborators
Second Affiliated Hospital of Soochow University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Responsible party
Sponsor
First posted
Sep 1, 2020
Start date
Aug 31, 2020
Primary completion
Sep 1, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Nov 25, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

REM Sleep Behavior Disorder→

Other studies from this sponsor

Ruijin Hospital

Start the discussion