NCT04534023

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rapid Eye Movement Sleep Behavior Disorder
• Synucleinopathy

Interventions

Type	Name	Description
DRUG	Idebenone	trial group
DRUG	Placebo	control group

Timeline

• Start date: 2020-08-31
• Primary completion: 2026-09-01
• Completion: 2026-11-30
• First posted: 2020-09-01
• Last updated: 2025-11-25

Locations

1 site across 1 country: China