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

NCT07384429 | Recruiting Phase 4

• 1 other identifier: 2025401
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson's Disease; Insomnia; Motor Disorder

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

  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)

  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 Outcomes (3)

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

  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)

  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)

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

Study Arms (2)

placebo

PLACEBO COMPARATOR

oral matching placebo

Drug: placebo

Lemborexant

EXPERIMENTAL

oral Lemborexant (5 mg/day)

Drug: Lemborexant

Interventions

Lemborexant DRUG

Participants will receive oral Lemborexant (5 mg/day) nightly approximately 5-30 minutes before going to bed for 28 consecutive days.

Lemborexant

placebo DRUG

Participants will receive a matching placebo nightly approximately 5-30 minutes before going to bed for 28 consecutive days.

placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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 since diagnosis, clinically stable, and able to comply with the research assessments and interventions;
• \. 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;
• \. 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 may not qualify if:

• \. 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 (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;
• \. Severe cognitive impairment (Mini-Mental State Examination (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 self-reported daily daytime napping ≥ 1 hour per day on ≥ 3 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.

Sponsors & Collaborators

• YangPan: lead
• Eisai China Inc.: collaborator
• Nanjing University: collaborator

Study Sites (1)

Zhongnan hospital

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Sleep Initiation and Maintenance Disorders; Motor Disorders

Interventions

lemborexant

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Central Study Contacts

Yang Pan, Chief Physician

CONTACT

02582263671; neuro_panyang@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-02

Locations

CN (1)