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

NCT04534023 | Active Not Recruiting Phase 2

• 1 other identifier: Ruijinlj
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Rapid Eye Movement Sleep Behavior Disorder; Synucleinopathy

Outcome Measures

Primary Outcomes (2)

• Effective

  5-year conversion rate of iRBD patients to synucleinopathies decreased

  5 years

• Ineffective

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

  5 years

Study Arms (2)

trial group

EXPERIMENTAL

Idebenone

Drug: Idebenone

control group

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Idebenone DRUG

trial group

trial group

Placebo DRUG

control group

control group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosed of iRBD.
• Age between 40 and 75.
• Be voluntarily to participate in the experiment by signing an informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Second Affiliated Hospital of Soochow University: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator

Study Sites (1)

Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (1)

• Li Y, Wang C, Luo N, Chen F, Zhou L, Niu M, Kang W, Liu J. Efficacy of idebenone in the Treatment of iRBD into Synucleinopathies (EITRS): rationale, design, and methodology of a randomized, double-blind, multi-center clinical study. Front Neurol. 2022 Sep 12;13:981249. doi: 10.3389/fneur.2022.981249. eCollection 2022.

  PMID: 36172027 DERIVED

MeSH Terms

Conditions

REM Sleep Behavior Disorder; Synucleinopathies

Interventions

idebenone

Condition Hierarchy (Ancestors)

REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 1, 2020
• Study Start: August 31, 2020
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 25, 2025

Record last verified: 2024-11

Locations

CN (1)