---
title: Lemborexant improves motor and sleep
nct_id: NCT07384429
phase: PHASE4
status: RECRUITING
sponsor: YangPan
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT07384429"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07384429"
last_fetched: "2026-05-10T14:02:32.716Z"
source: "Parkinson's Pathways (curated)"
---
# Lemborexant improves motor and sleep

**Goal (in five words):** Lemborexant improves motor and sleep

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

**Trial ID:** [NCT07384429](https://clinicaltrials.gov/study/NCT07384429)

## Key Facts

- **Phase:** PHASE4
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** YangPan
- **Target Enrollment:** 44 participants
- **Start Date:** 2026-03-19
- **Completion Date:** 2026-12-01
- **Conditions:** Parkinson's Disease, Insomnia, Motor Disorder
- **Interventions:** Lemborexant, placebo
- **Intervention Types:** DRUG

## Summary For Families

The goal is to break the cycle where insomnia and Parkinson's motor problems worsen each other, helping people sleep better at night so daytime motor symptoms and sleepiness are less disruptive. They are testing lemborexant, a dual orexin receptor antagonist that blocks orexin-1 and orexin-2 signals in the brain to reduce wakefulness and promote more continuous sleep; it does not change how levodopa works on dopamine, but it can add sedation so the study requires stable Parkinson's medications and monitors daytime sleepiness. The trial is looking for people aged 50 or older with idiopathic Parkinson's disease at Hoehn and Yahr stage 1 to 4, diagnosed at least 2 years ago, who have moderate to severe insomnia (Insomnia Severity Index 15 or higher) and have been on a stable medication regimen for at least 4 weeks. People with significant cognitive impairment, untreated sleep apnea or other breathing-related sleep disorders, severe psychiatric conditions, recent use of orexin-related or other sleep drugs, or frequent long daytime naps are not eligible.

## Eligibility

- **Minimum age:** 50 Years
- **Sex:** ALL

### Full 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.
```

## Locations (1)

- Zhongnan hospital, Wuhan, Hubei, China _(30.5833, 114.2667)_
  - Yang Pan, Chief Physician — (CONTACT) — 0258-2263671 — neuro_panyang@163.com

## Central Contacts

- Yang Pan, Chief Physician — (CONTACT) — 02582263671 — neuro_panyang@163.com

---

*Canonical: https://parkinsonspathways.com/trial/NCT07384429*  
*HTML version: https://parkinsonspathways.com/trial/NCT07384429*  
*Source data: https://clinicaltrials.gov/study/NCT07384429*