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

Sponsors

Lead Sponsor: Ruijin Hospital

Collaborator: Second Affiliated Hospital of Soochow University
Wuhan Union Hospital, China

Source Ruijin Hospital
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.

Overall Status Not yet recruiting
Start Date September 1, 2020
Completion Date September 30, 2026
Primary Completion Date September 1, 2026
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Effective 5 years
Ineffective 5 years
Enrollment 142
Condition
Intervention

Intervention Type: Drug

Intervention Name: Idebenone

Description: trial group

Arm Group Label: trial group

Intervention Type: Drug

Intervention Name: Placebo

Description: control group

Arm Group Label: control group

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 40 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Contact

Last Name: Jun Liu, Professor

Phone: 64370045

Phone Ext.: +86-021

Email: [email protected]

Location
Facility: Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Location Countries

China

Verification Date

September 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: trial group

Type: Experimental

Label: control group

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov