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
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.
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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.