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

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status and phase

Enrolling
Phase 2

Conditions

Synucleinopathy
Rapid Eye Movement Sleep Behavior Disorder

Treatments

Drug: Idebenone
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04534023
Ruijinlj

Details and patient eligibility

About

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.

Enrollment

142 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

142 participants in 2 patient groups, including a placebo group

trial group
Experimental group
Treatment:
Drug: Idebenone
control group
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Jun Liu, Professor

Data sourced from clinicaltrials.gov

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