Lemborexant for improving sleep in epilepsy patients
Lemborexant Treatment of Insomnia Linked to Epilepsy
PHASE3 · University of Manitoba · NCT06262594
This study is testing if Lemborexant can help people with epilepsy sleep better compared to a placebo.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Manitoba (other) |
| Locations | 2 sites (Durham, North Carolina and 1 other locations) |
| Trial ID | NCT06262594 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with sleep-related focal epilepsy who are using contraception.
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.
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 performed: While this approach is relatively novel, similar studies exploring sleep treatments in epilepsy have shown promising results.
Eligibility criteria
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 this trial is running
Durham, North Carolina and 1 other locations
- Duke University — Durham, North Carolina, United States (NOT_YET_RECRUITING)
- Health Sciences Centre — Winnipeg, Manitoba, Canada (RECRUITING)
Study contacts
- Study coordinator: Marcus C Ng, MD, FRCPC
- Email: letoile@umanitoba.ca
- Phone: 204-787-2684
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.