Parkinson's DiseasePhase 4NCT07384429
Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease
A Phase 4 study testing Lemborexant in people with Parkinson's Disease and Insomnia, run by YangPan at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson's Disease, Insomnia, Motor Disorder
- What is being tested?
- Lemborexant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 19 Aug 2026to 1 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongnan hospital
Wuhan, Hubei, 430000
Yang Pan, Chief Physician, 0258-2263671, neuro_panyang@163.com
About this study
Official title: 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.
Read the 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:
- To evaluate the effect of oral Lemborexant on Parkinson's disease motor symptoms in participants (using the Unified Parkinson's Disease Rating Scale, UPDRS);
- 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)).
- Conditions
- Parkinson's Disease, Insomnia, Motor Disorder
- Being tested
- Lemborexant, placebo
- Keywords
- Parkinson's Disease, Lemborexant, orexin receptor antagonist, Insomnia, Motor Disorder
- Medical subject headings
- Parkinson Disease, Sleep Initiation and Maintenance Disorders, Motor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LemborexantDrug
Participants will receive oral Lemborexant (5 mg/day) nightly approximately 5-30 minutes before going to bed for 28 consecutive days.
placeboDrug
Participants will receive a matching placebo nightly approximately 5-30 minutes before going to bed for 28 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | oral matching placebo Receives: Drug: placebo |
| Lemborexant | Experimental | oral Lemborexant (5 mg/day) Receives: Drug: Lemborexant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Baseline, at the end of the 7-day post-treatment, at the end of the 28-day post-treatment, 7-day follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start19 Aug 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YangPan
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai China Inc., Nanjing University
- Responsible party
- Sponsor-investigator, YangPan, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384429
- Sponsor's protocol ID
- 2025401
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for the Dual Orexin Receptor Antagonist Lemborexant in Improving Motor-Sleep Comorbidity in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07384429
- Acronym / sponsor ID
- 2025401
- Conditions
- Parkinson's Disease, Insomnia, Motor Disorder
- Keywords
- Parkinson's Disease, Lemborexant, orexin receptor antagonist, Insomnia, Motor Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- YangPanUniversity, hospital or other
- Collaborators
- Eisai China Inc., Nanjing University
- Study start
- 19 Aug 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- To evaluate the effect of oral Lemborexant on Parkinson's disease motor symptoms in participants (using the Unified Parkinson's Disease Rating Scale, UPDRS);
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebooral matching placebo |
| Lemborexant | Experimental | Drug: Lemborexantoral Lemborexant (5 mg/day) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LemborexantParticipants will receive oral Lemborexant (5 mg/day) nightly approximately 5-30 minutes before going to bed for 28 consecutive days. | Drug | Lemborexant |
| placeboParticipants will receive a matching placebo nightly approximately 5-30 minutes before going to bed for 28 consecutive days. | Drug | placebo |
Primary outcome
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.
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.
3 secondary outcomes
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lemborexant in people with Parkinson's Disease and Insomnia, run by YangPan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Pan, Chief Physician (02582263671, neuro_panyang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.