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RecruitingNCT06262594L'ÉTOILEUpdated Feb 13, 2025

Lemborexant Treatment of Insomnia Linked to Epilepsy

A Phase 3 interventional study of Lemborexant and Placebo in Epilepsy and Sleep, sponsored by University of Manitoba. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.

Sponsored by University of Manitoba · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Oct 2024; still recruiting 1 year 11 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy.

02

Conditions studied

  • Epilepsy
  • Sleep

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03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's planned enrollment of 26 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Sleep-related focal epilepsy
  • Contraception

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
26 participants (estimated)

Study arms

  • Placebo comparator
    Placebo First

    0mg

    Drug: Lemborexant · Drug: Placebo

  • Active comparator
    Investigational Product First

    10mg qhs

    Drug: Lemborexant · Drug: Placebo

Interventions

  • DrugLemborexant

    Drug is administered

    Also known as: Dayvigo

  • DrugPlacebo

    Drug is administered

06

What researchers measure

Primary outcomes

  1. WASO

    Wake After Sleep Onset (recorded using PSG)

    Time frame: 36 Days

07

Study locations

1 of 2 sites recruiting
  • Duke University
    Durham, North Carolina 27708, United States
    Not yet recruiting
  • Health Sciences Centre
    Winnipeg, Manitoba R3A1R9, Canada
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06262594
Lead sponsor
University of Manitoba
Collaborators
Duke University
Responsible party
Sponsor
First posted
Feb 16, 2024
Start date
Oct 29, 2024
Primary completion
Apr 18, 2026 (estimated)
Completion
Apr 18, 2027 (estimated)
Last update
Feb 13, 2025

Study contacts

Marcus C Ng, MD, FRCPC
Contact
letoile@umanitoba.ca
204-787-2684

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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