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Lemborexant for Epilepsy (L'ÉTOILE Trial)

Phase 3
Recruiting
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Sleep-related focal epilepsy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 days
Awards & highlights
Pivotal Trial

Summary

This trial aims to see if a medication called Lemborexant can help improve the sleep of people with epilepsy.

Who is the study for?
This clinical trial is for individuals who have sleep-related focal epilepsy and are willing to use contraception. It's not specified, but typically participants would need to be in good general health aside from their epilepsy and insomnia.
What is being tested?
The trial is testing Lemborexant, a potential treatment for insomnia in people with epilepsy. Participants will either receive Lemborexant or a placebo (a pill without any active drug) to see if there's an improvement in sleep.
What are the potential side effects?
While the side effects of Lemborexant aren't listed here, common ones may include drowsiness during the day, headaches, dizziness, and potentially worsening of depression or suicidal thoughts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have epilepsy that occurs during sleep.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
WASO

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Investigational Product FirstActive Control2 Interventions
10mg qhs
Group II: Placebo FirstPlacebo Group2 Interventions
0mg

Find a Location

Who is running the clinical trial?

University of ManitobaLead Sponsor
621 Previous Clinical Trials
206,537 Total Patients Enrolled
1 Trials studying Epilepsy
500 Patients Enrolled for Epilepsy
Duke UniversityOTHER
2,462 Previous Clinical Trials
2,968,894 Total Patients Enrolled
12 Trials studying Epilepsy
31,648 Patients Enrolled for Epilepsy
~6 spots leftby Apr 2025
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