Lemborexant for sleep and movement problems in Parkinson's disease

Study for the Dual Orexin Receptor Antagonist Lemborexant in Improving Motor-Sleep Comorbidity in Parkinson's Disease

This trial will test whether taking lemborexant each night helps people with Parkinson's disease who have both motor symptoms and insomnia.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Zhongnan Hospital (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07384429 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled Phase 4 study enrolls people with idiopathic Parkinson's disease and clinically significant insomnia and gives them 5 mg lemborexant or placebo nightly for 28 days. Participants are assessed at baseline and at scheduled follow-up visits during and after treatment to track sleep, motor symptoms, and safety. The rationale is that orexin neurons influence both sleep-wake regulation and motor control, so blocking orexin receptors may improve both insomnia and motor comorbidity in PD. The trial is single-site and includes patients with stable PD medications and Hoehn & Yahr stage 1–4.

Who should consider this trial

Good fit: Ideal candidates are people age 50 or older with diagnosed idiopathic Parkinson's disease (Hoehn & Yahr stage 1–4), at least two years since diagnosis, stable medications, and moderate-to-severe insomnia (ISI ≥ 15).

Not a fit: Patients with severe psychiatric disorders, unstable PD treatment, non-insomnia primary sleep disorders (for example untreated sleep apnea), or other exclusions listed by the trial are less likely to benefit from participation.

Why it matters

Potential benefit: If successful, lemborexant could improve nighttime sleep and may also reduce daytime motor disturbances for people with Parkinson's disease and insomnia.

How similar studies have performed: Dual orexin receptor antagonists like lemborexant are established treatments for insomnia, but using them specifically to improve motor symptoms in Parkinson's disease is largely novel with limited prior clinical data.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 this trial is running

Wuhan, Hubei

• Zhongnan hospital — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Yang Pan, Chief Physician

Conditions Parkinson's Disease; Insomnia; Motor Disorder; Lemborexant; orexin receptor antagonist