Lemborexant Treatment of Insomnia Linked to Epilepsy

Last updated: February 10, 2025
Sponsor: University of Manitoba
Overall Status: Active - Recruiting

Phase

3

Condition

Epilepsy

Treatment

Placebo

Lemborexant

Clinical Study ID

NCT06262594
L'ÉTOILE
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Sleep-related focal epilepsy

  • Contraception

Exclusion

Exclusion Criteria:

  • Changes in antiseizure medication 1 month before study protocol or during studyprotocol

  • 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 asgalactosemia or glucose-galactose malabsorption

  • Individuals with a history of dependence or tolerance - abuse, dependence, reboundinsomnia

  • Individuals with psychiatric disorders with abnormal thinking and behaviouralchanges, depression, or suicidal ideation

  • Individuals with a diagnosis of narcolepsy

Study Design

Total Participants: 26
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
October 29, 2024
Estimated Completion Date:
April 18, 2027

Connect with a study center

  • Health Sciences Centre

    Winnipeg, Manitoba R3A1R9
    Canada

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27708
    United States

    Site Not Available

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