- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04534023
A Clinical Study of the Efficacy of Idebenone in the Treatment of iRBD Into Synucleinopathies
May 8, 2023 updated by: Ruijin Hospital
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
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
142
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jun Liu, Professor
- Phone Number: +86-021 64370045
- Email: jly0520@hotmail.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200025
- Recruiting
- Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
-
Contact:
- Jun Liu, Professor
- Phone Number: +86-021 64370045
- Email: jly0520@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Clinical diagnosed of iRBD.
- Age between 40 and 75.
- Be voluntarily to participate in the experiment by signing an informed consent form.
Exclusion Criteria:
- Sleep apnea hypopnea syndrome
- Slow movement, muscle rigidity, tremor or postural instability.
- Neurological diseases such as cerebral hemorrhage, cerebral infarction, brain trauma, brain tumor or central nervous system infection.
- Other sleep disorders or seizures.
- Alcoholism or drug addiction patients.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: control group
|
control group
|
Experimental: trial group
|
trial group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effective
Time Frame: 5 years
|
5-year conversion rate of iRBD patients to synucleinopathies decreased
|
5 years
|
Ineffective
Time Frame: 5 years
|
5-year conversion rate of iRBD patients to synucleinopathies remained unchanged or increased.
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Anticipated)
September 1, 2026
Study Completion (Anticipated)
September 30, 2026
Study Registration Dates
First Submitted
August 26, 2020
First Submitted That Met QC Criteria
August 26, 2020
First Posted (Actual)
September 1, 2020
Study Record Updates
Last Update Posted (Actual)
May 9, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Nervous System Diseases
- Sleep Wake Disorders
- Neurodegenerative Diseases
- Parasomnias
- Proteostasis Deficiencies
- REM Sleep Parasomnias
- Mental Disorders
- Synucleinopathies
- REM Sleep Behavior Disorder
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Antioxidants
- Idebenone
Other Study ID Numbers
- Ruijinlj
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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