Lemborexant improves motor and sleep
- Trial ID
- NCT07384429
- Official Title
- Study for the Dual Orexin Receptor Antagonist Lemborexant in Improving Motor-Sleep Comorbidity in Parkinson's Disease
- Goal
- Lemborexant improves motor and sleep
- Phase
- PHASE4
- Status
- RECRUITING
- Sponsor
- YangPan
- Study Type
- INTERVENTIONAL
- Enrollment
- 44 participants
- Conditions
- Parkinson's Disease, Insomnia, Motor Disorder
- Interventions
- Lemborexant, placebo
Plain-Language Summary
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.
Locations
- Zhongnan hospital, Wuhan, Hubei, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Lemborexant. 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.
- Who can participate?
- Participants must be at least 50 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 4 trial is estimated to last approximately 8 months.