Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease

Starting soon · Phase 4 · Has a placebo group

Conditions studied: Parkinson's Disease, Insomnia, Motor Disorder

In brief

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.

Key facts

Study ID

NCT07384429

Run by

YangPan

People needed

44

Starts

2026-08-19

Expected to finish

2026-12-01

Last updated by the study team

2026-06-11

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Aged 50 years or older;
• 2. 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;
• 3. Disease duration of ≥ 2 years since diagnosis, clinically stable, and able to comply with the research assessments and interventions;
• 4. Diagnosis of insomnia disorder meeting the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with an Insomnia Severity Index (ISI) score of ≥ 15;
• 5. Stable medication regimen for at least 4 weeks prior to the study;
• 6. Signed informed consent form, with the participant or their legal guardian able to understand and willing to participate in this study.

You may not qualify if…

• 1. History of or diagnosis with a severe psychiatric disorder, such as depression, anxiety disorders, schizophrenia spectrum disorders, or bipolar disorder;
• 2. Presence of a clinically defined neurological disorder (assessed via self-report), including but not limited to: any condition potentially associated with increased intracranial pressure, space-occupying brain lesions, history of stroke, transient ischemic attack within the past 2 years, cerebral aneurysm, dementia, or multiple sclerosis;
• 3. Severe cognitive impairment (Mini-Mental State Examination (MMSE) score below 24) or inability to complete questionnaires independently;
• 4. Chronic obstructive pulmonary disease (COPD) or any lifelong history of sleep-related breathing disorders, such as sleep apnea;
• 5. Excessive daytime sleepiness, defined as self-reported daily daytime napping ≥ 1 hour per day on ≥ 3 days per week;
• 6. Regular caffeine consumption;
• 7. Use of any orexin receptor related medication within the past 3 months.
• 8. Previous history of cataplexy or known reduced orexin levels;
• 9. Inability to read or understand Chinese;
• 10. Use of other sleep-promoting medications within the past 3 months.

Where it is running

• Zhongnan hospital — Wuhan, Hubei, China

Full record on ClinicalTrials.gov

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