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NCT Number: NCT04534023

A Clinical Study of the Efficacy of Idebenone in the Treatment of iRBD 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Rapid Eye Movement Sleep Behavior Disorder Mental Disorders Metabolic Diseases Nervous System Diseases Neurodegenerative Diseases Nutritional and Metabolic Diseases Parasomnias Proteostasis Deficiencies REM Sleep Behavior Disorder REM Sleep Parasomnias Sleep Wake Disorders Synucleinopathies Synucleinopathy

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosed of iRBD.
  • Age between 40 and 75.
  • Be voluntarily to participate in the experiment by signing an informed consent form.

Exclusion criteria

  • 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.

Treatment and study plan

Idebenone

Drug

trial group

Placebo

Drug

control group

Primary outcomes

  1. Effective

    Time frame: 5 years

    5-year conversion rate of iRBD patients to synucleinopathies decreased

  2. Ineffective

    Time frame: 5 years

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

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Sep 1, 2020
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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