Lemborexant for improving sleep in epilepsy patients
Official title: Lemborexant Treatment of Insomnia Linked to Epilepsy
Run by University of Manitoba · NCT06262594 · Data updated 2026-11-12
This study is testing if Lemborexant can help people with epilepsy sleep better compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 26 (estimated) |
| Sponsor | University of Manitoba Academic / other |
| Locations | 2 sites (Durham, North Carolina and 1 other locations) |
| Status | Recruiting |
| Started | October 29, 2024 |
| Main results expected | April 18, 2026 |
| Study ends | April 18, 2027 |
| Registry record updated | February 13, 2025 |
| Trial ID | NCT06262594 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults with sleep-related focal epilepsy who are using contraception.
✕Probably not a fit
Patients with certain psychiatric disorders, those with a history of substance dependence, or individuals with complex sleep-related behaviors may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of Lemborexant, a medication designed to treat insomnia, in patients suffering from epilepsy. Participants will be randomly assigned to receive either Lemborexant or a placebo to assess improvements in sleep quality. The study focuses on individuals with sleep-related focal epilepsy and will monitor their response to treatment over a specified period. The trial is being conducted at multiple locations, including Duke University and the Health Sciences Centre in Winnipeg.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance sleep quality for patients with epilepsy, improving their overall quality of life.
How similar studies have gone: While this approach is relatively novel, similar studies exploring sleep treatments in epilepsy have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Sleep-related focal epilepsy * Contraception Exclusion Criteria: * Changes in antiseizure medication 1 month before study protocol or during study protocol * Concomitant medications per SUNRISE1 * Individuals with hepatic impairment * Female participants who are pregnant or breastfeeding * Individuals with compromised respiratory function * Individuals with a history of complex sleep-related behaviour * Individuals with rare hereditary diseases of galactose intolerance such as galactosemia or glucose-galactose malabsorption * Individuals with a history of dependence or tolerance - abuse, dependence, rebound insomnia * Individuals with psychiatric disorders with abnormal thinking and behavioural changes, depression, or suicidal ideation * Individuals with a diagnosis of narcolepsy
Where it's running
-
Health Sciences Centre
Winnipeg, Manitoba, Canada Recruiting -
Duke University
Durham, North Carolina, United States Not yet recruiting
Study contacts
- Study coordinator: Marcus C Ng, MD, FRCPC
- Email: letoile@umanitoba.ca
- Phone: 204-787-2684
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.