Lemborexant Treatment of Insomnia Linked to Epilepsy (L'ÉTOILE)

February 10, 2025 updated by: University of Manitoba
The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A1R9
        • Recruiting
        • Health Sciences Centre
        • Contact:
  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27708
        • Not yet recruiting
        • Duke University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo First
0mg
Drug: Lemborexant
Drug is administered
Other Names:
  • Dayvigo
Drug: Placebo
Drug is administered
Active Comparator: Investigational Product First
10mg qhs
Drug: Lemborexant
Drug is administered
Other Names:
  • Dayvigo
Drug: Placebo
Drug is administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WASO
Time Frame: 36 Days
Wake After Sleep Onset (recorded using PSG)
36 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2024

Primary Completion (Estimated)

April 18, 2026

Study Completion (Estimated)

April 18, 2027

Study Registration Dates

First Submitted

December 21, 2023

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L'ÉTOILE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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