Testing Idebenone for treating REM Sleep Behavior Disorder
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
This study is testing if Idebenone can help people with REM Sleep Behavior Disorder and possibly slow down the progression of related diseases.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT04534023 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the efficacy of Idebenone in patients diagnosed with idiopathic REM Sleep Behavior Disorder (iRBD) and its potential to delay progression into synucleinopathies. A total of 142 patients will be recruited and randomly assigned to either a treatment group receiving Idebenone or a control group receiving a placebo. Over a period of five years, participants will undergo regular evaluations, including questionnaires, blood tests, and imaging studies, to assess the treatment's effectiveness and safety. The study hypothesizes that Idebenone will be both safe and effective in managing the progression of the disease.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 to 75 who have been clinically diagnosed with iRBD.
Not a fit: Patients with other neurological disorders or sleep disorders, such as sleep apnea or seizures, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly delay the progression of iRBD into more severe synucleinopathies.
How similar studies have performed: While this approach is novel in the context of iRBD, similar studies targeting synucleinopathies have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai
- Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Jun Liu, Professor
- Email: jly0520@hotmail.com
- Phone: 64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.