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

Sponsor
YangPan
Study ID
NCT07384429
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 19, 2026
Status verified
Feb 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: placebo
    oral matching placebo
  • Experimental: Lemborexant
    oral Lemborexant (5 mg/day)

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. ]

Central Contacts

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