NCT06262594RecruitingPhase 3
Lemborexant Treatment of Insomnia Linked to Epilepsy
Source: ClinicalTrials.gov · Last updated 13 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- First submitted
- 21 Dec 2023
- Start date
- 29 Oct 2024
- Primary completion date
- 18 Apr 2026
- Lead sponsor
- University of Manitoba
- Diseases
- Epilepsy
- NCT number
- NCT06262594
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 26
- From 29 Oct 2024 to the primary completion date, 18 Apr 2026
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Changes in antiseizure medication 1 month before study protocol or during study protocol
- Concomitant medications per SUNRISE1
Other illness
- Individuals with hepatic impairment
- Individuals with a history of complex sleep-related behaviour
- 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
Lab values
- Individuals with rare hereditary diseases of galactose intolerance such as galactosemia or glucose-galactose malabsorption
Other
- Female participants who are pregnant or breastfeeding
- Individuals with compromised respiratory function
- Individuals with a diagnosis of narcolepsy
Who the study is looking for
- Sleep-related focal epilepsy
- Contraception
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Health Sciences Centre Coordinator of this site? Confirm its status | Winnipeg | Canada | Recruiting |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.