Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50+
SponsorYangPan
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Lemborexant
- placebo
Treatment groups
44 Participants
are divided into 2 treatment groupsSponsors and collaborators
YangPan
Lead sponsor
Zhongnan Hospital
Sponsor institution
Eisai China Inc.
Collaborator
Nanjing University
Collaborator
Source ClinicalTrials.gov