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

Sponsor
Ruijin Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04534023
Collaborator
Second Affiliated Hospital of Soochow University (Other), Wuhan Union Hospital, China (Other)
142
Enrollment
1
Location
2
Arms
72.9
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
142 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2026
Anticipated Study Completion Date :
Sep 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: trial group

Drug: Idebenone
trial group
Placebo Comparator: control group

Drug: Placebo
control group

Outcome Measures

Primary Outcome Measures

  1. Effective [5 years]

    5-year conversion rate of iRBD patients to synucleinopathies decreased

  2. Ineffective [5 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai China 200025

Sponsors and Collaborators

  • Ruijin Hospital
  • Second Affiliated Hospital of Soochow University
  • Wuhan Union Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT04534023
Other Study ID Numbers:
  • Ruijinlj
First Posted:
Sep 1, 2020
Last Update Posted:
Apr 28, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Synucleinopathies
REM Sleep Behavior Disorder
Mental Disorders
Idebenone

Study Results

No Results Posted as of Apr 28, 2022