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

March 19, 2026 updated by: YangPan

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Parkinson's disease (PD) is the most common movement disorder. Its core motor symptoms include bradykinesia, resting tremor, muscle rigidity, and postural instability. Furthermore, patients frequently experience severe non-motor symptoms, such as sleep disorders and mood/affective disturbances. Among these, sleep disorders, especially insomnia, are one of the most prevalent non-motor symptoms. They are often overlooked in clinical management. The axons of central orexin neurons project extensively throughout the brain, encompassing key regions such as motor control centers and sleep-wake regulation centers. During the pathological process of PD, dysfunctional orexin neurons may contribute to the disruption of both motor and sleep functions by modulating these target areas.

By recruiting PD patients with comorbid motor and insomnia symptoms, the investigators will investigate the efficacy of Lemborexant in treating both motor and sleep disturbances in PD patients. With its advantages of target specificity, established safety, and a lower side-effect profile compared to traditional hypnotics, Lemborexant holds promise as a novel therapeutic intervention for Parkinson's disease. This research may offer new possibilities for expanding clinical treatment strategies for PD. Participants will take 5 mg medication (or placebo) each night for 28 days and be asked to come for 4 times study visits (Baseline, at the end of the 7-day post-treatment, at the end of the 28-day post-treatment, 7-day follow up).

The major experiment contents include:

  1. To evaluate the effect of oral Lemborexant on Parkinson's disease motor symptoms in participants (using the Unified Parkinson's Disease Rating Scale, UPDRS);
  2. To evaluate the effect of oral Lemborexant on the sleep quality of participants (using the Parkinson's Disease Sleep Scale (PDSS), the Insomnia Severity Index (ISI), the Pittsburgh Sleep Quality Index (PSQI)).

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Zhongnan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
oral matching placebo
Drug: placebo
Participants will receive a matching placebo nightly approximately 5-30 minutes before going to bed for 28 consecutive days.
Experimental: Lemborexant
oral Lemborexant (5 mg/day)
Drug: Lemborexant
Participants will receive oral Lemborexant (5 mg/day) nightly approximately 5-30 minutes before going to bed for 28 consecutive days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the scores of Part III of the Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame: Baseline, at the end of the 7-day post-treatment, at the end of the 28-day post-treatment, 7-day follow up.
The scores of Part III of the UPDRS (motor examination) score will be collected from each participant to measure the severity of motor ability with scores ranging from 0 (minimum) to 108 (maximum). The higher scores mean a worse outcome.
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 the Parkinson's Disease Sleep Scale (PDSS)
Time Frame: Baseline, at the end of the 7-day post-treatment, at the end of the 28-day post-treatment, 7-day follow up.
PDSS is used to quantify the severity of sleep problems associated with Parkinson's disease. Its score ranges from 0 (minimum) to 150 (maximum), with lower scores indicating more severe sleep disturbances. Typically, a total score below 90 is considered indicative of a clinically significant sleep disorder.
Baseline, at the end of the 7-day post-treatment, at the end of the 28-day post-treatment, 7-day follow up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the scores of Part II of the Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame: Baseline, at the end of the 7-day post-treatment, at the end of the 28-day post-treatment, 7-day follow up.
The scores of Part II of the UPDRS (daily living activities) score will be collected from each participant to measure the severity of daily living activities with scores ranging from 0 (minimum) to 52 (maximum). The higher scores mean a worse outcome.
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 the Insomnia Severity Index (ISI)
Time Frame: Baseline, at the end of the 7-day post-treatment, at the end of the 28-day post-treatment, 7-day follow up.
ISI is used to screen for and assess the severity of insomnia. Its score ranges from 0 (minimum) to 28 (maximum), with higher scores indicating more severe sleep problems. A total score of 10 or above suggests the presence of clinically significant insomnia.
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 the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, at the end of the 7-day post-treatment, at the end of the 28-day post-treatment, 7-day follow up.
PSQI is used to comprehensively evaluate multiple aspects of sleep quality. Its score ranges from 0 (minimum) to 21 (maximum), with higher scores indicating poorer sleep quality. A total score greater than 5 is generally considered to indicate poor sleep quality.
Baseline, at the end of the 7-day post-treatment, at the end of the 28-day post-treatment, 7-day follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

YangPan

Collaborators

Nanjing University
Eisai China Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson's Disease

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe