RecruitingPhase 3NCT06262594

Lemborexant Treatment of Insomnia Linked to Epilepsy


Sponsor

University of Manitoba

Enrollment

26 participants

Start Date

Oct 29, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Sleep-related focal epilepsy
  • Contraception

Exclusion Criteria10

  • 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

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Interventions

DRUGLemborexant

Drug is administered

DRUGPlacebo

Drug is administered


Locations(2)

Duke University

Durham, North Carolina, United States

Health Sciences Centre

Winnipeg, Manitoba, Canada

View Full Details on ClinicalTrials.gov

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NCT06262594


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