Actively Recruiting
Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease
Led by YangPan · Updated on 2026-03-23
44
Participants Needed
1
Research Sites
36 weeks
Total Duration
On this page
Sponsors
Y
YangPan
Lead Sponsor
E
Eisai China Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this study is to explore the effects of the dual orexin receptor antagonist Lemborexant on improving motor and sleep comorbidity in patients with Parkinson's disease. This study will provide clinical evidence for the application of dual orexin receptor antagonists in the treatment of Parkinson's Disease.
CONDITIONS
Official Title
Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 50 years or older
- Diagnosed with idiopathic Parkinson's disease according to the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease (2015), with a Hoehn & Yahr stage of 1 to 4
- Disease duration of 2 years or more since diagnosis, clinically stable, and able to comply with the research assessments and interventions
- Diagnosis of insomnia disorder meeting DSM-5 criteria, with an Insomnia Severity Index (ISI) score of 15 or higher
- Stable medication regimen for at least 4 weeks prior to the study
- Signed informed consent form, with the participant or their legal guardian able to understand and willing to participate in this study
You will not qualify if you...
- History of or diagnosis with a severe psychiatric disorder, such as depression, anxiety disorders, schizophrenia spectrum disorders, or bipolar disorder
- Presence of a clinically defined neurological disorder, including increased intracranial pressure, brain lesions, history of stroke, transient ischemic attack within 2 years, cerebral aneurysm, dementia, or multiple sclerosis
- Severe cognitive impairment (MMSE score below 24) or inability to complete questionnaires independently
- Chronic obstructive pulmonary disease (COPD) or any lifelong history of sleep-related breathing disorders, such as sleep apnea
- Excessive daytime sleepiness, defined as daily napping 1 hour or more on 3 or more days per week
- Regular caffeine consumption
- Use of any orexin receptor related medication within the past 3 months
- Previous history of cataplexy or known reduced orexin levels
- Inability to read or understand Chinese
- Use of other sleep-promoting medications within the past 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongnan hospital
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
Y
Yang Pan, Chief Physician
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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