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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04534023

Enrollment

Registered

2020-09-01

Start date

2020-08-31

Completion date

2026-11-30

Last updated

2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rapid Eye Movement Sleep Behavior Disorder, Synucleinopathy

Brief 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.

Interventions

DRUGIdebenone

trial group

DRUGPlacebo

control group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026