EpilepsyPhase 3L'ÉTOILENCT06262594
Lemborexant Treatment of Insomnia Linked to Epilepsy
A Phase 3 study testing Lemborexant in people with Epilepsy and Sleep, run by University of Manitoba at 2 sites in 2 countries.
Trial summary
The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Lemborexant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 29 Oct 2024to 18 Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sleep-related focal epilepsy
- Contraception
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Not yet recruiting
Duke University
Durham, North Carolina, 27708
Birgit Frauscher, MD, PhD, 919-681-1700, birgit.frauscher@duke.edu
Canada1 site, 1 recruiting
- Recruiting
Health Sciences Centre
Winnipeg, Manitoba, R3A1R9
Marcus Ng, MD, FRCPC, 204-787-2684, letoile@umanitoba.ca
About this study
The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy.
- Being tested
- Lemborexant, Placebo
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LemborexantDrug
Also called Dayvigo
Drug is administered
PlaceboDrug
Drug is administered
| Study group | Role | What they receive |
|---|---|---|
| Placebo First | Placebo comparator | 0mg Receives: Drug: Lemborexant; Drug: Placebo |
| Investigational Product First | Active comparator | 10mg qhs Receives: Drug: Lemborexant; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
WASO
Wake After Sleep Onset (recorded using PSG)
Measured: 36 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start29 Oct 2024
- Primary completion18 Apr 2026 (estimated)
- Study completion18 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262594
- Sponsor's protocol ID
- L'ÉTOILE
- Acronym
- L'ÉTOILE
- Status last verified
- Feb 2025
- First submitted
- 21 Dec 2023
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lemborexant Treatment of Insomnia Linked to Epilepsy
- ClinicalTrials.gov ID
- NCT06262594
- Acronym / sponsor ID
- L'ÉTOILE / L'ÉTOILE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Duke University
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 18 Apr 2026 (estimated)
- Study completion
- 18 Apr 2027 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo First | Placebo comparator | Drug: Lemborexant, Drug: Placebo0mg |
| Investigational Product First | Active comparator | Drug: Lemborexant, Drug: Placebo10mg qhs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sleep-related focal epilepsy
- Contraception
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LemborexantAlso: DayvigoDrug is administered | Drug | Investigational Product First, Placebo First |
| PlaceboDrug is administered | Drug | Investigational Product First, Placebo First |
Primary outcome
WASO
Time frame: 36 Days
Wake After Sleep Onset (recorded using PSG)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lemborexant in people with Epilepsy and Sleep, run by University of Manitoba at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcus C Ng, MD, FRCPC (204-787-2684, letoile@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WASO (time frame: 36 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.