Not Yet RecruitingPhase 4

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

China44 participantsStarted 2026-08-19

Plain-language summary

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.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 pulmon…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in the scores of the Parkinson's Disease Sleep Scale (PDSS)

Timeframe: Baseline, at the end of the 7-day post-treatment, at the end of the 28-day post-treatment, 7-day follow up.

Changes in the scores of Part III of the Unified Parkinson's Disease Rating Scale (UPDRS)

Timeframe: Baseline, at the end of the 7-day post-treatment, at the end of the 28-day post-treatment, 7-day follow up.

Trial details

NCT IDNCT07384429

SponsorYangPan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01

Contact for this trial

Yang Pan, Chief Physician

02582263671 neuro_panyang@163.com

View on ClinicalTrials.gov More Parkinson's Disease trials

Plain-language summary

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Changes in the scores of the Parkinson's Disease Sleep Scale (PDSS)

Timeframe: Baseline, at the end of the 7-day post-treatment, at the end of the 28-day post-treatment, 7-day follow up.

Changes in the scores of Part III of the Unified Parkinson's Disease Rating Scale (UPDRS)

Timeframe: Baseline, at the end of the 7-day post-treatment, at the end of the 28-day post-treatment, 7-day follow up.