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

Rapid Eye Movement Sleep Behavior Disorder Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04534023
• Other study ID #: Ruijinlj
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2020
• Est. completion date: September 30, 2026

Study information

• Verified date: May 2022
• Source: Ruijin Hospital
• Contact: Jun Liu, Professor
• Phone: 64370045
• Email: jly0520[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: September 30, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Rapid Eye Movement Sleep Behavior Disorder
• REM Sleep Behavior Disorder
• Synucleinopathy

Intervention

Drug:
• Idebenone
trial group
• Placebo
control group

Locations

Country	Name	City	State
China	Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Ruijin Hospital	Second Affiliated Hospital of Soochow University, Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective	5-year conversion rate of iRBD patients to synucleinopathies decreased	5 years
Primary	Ineffective	5-year conversion rate of iRBD patients to synucleinopathies remained unchanged or increased.	5 years