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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Lemborexant
DrugParticipants will receive oral Lemborexant (5 mg/day) nightly approximately 5-30 minutes before going to bed for 28 consecutive days.
placebo
DrugParticipants will receive a matching placebo nightly approximately 5-30 minutes before going to bed for 28 consecutive days.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: placeboPlacebo comparator 1 intervention
Group B: LemborexantExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
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.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.
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.Secondary outcomes
1
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.
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.2
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.
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.3
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.
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.Sponsors and contacts
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YangPan
Lead sponsor
Zhongnan Hospital
Sponsor institution
Eisai China Inc.
Collaborator
Nanjing University
Collaborator
Source ClinicalTrials.gov
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