RECRUITING

Lemborexant Treatment of Insomnia Linked to Epilepsy

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Lemborexant Treatment of Insomnia Linked to Epilepsy

Quick Facts

Study Start:2024-10-29
Study Completion:2027-04-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06262594

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Sleep-related focal epilepsy
  2. * Contraception
  1. * Changes in antiseizure medication 1 month before study protocol or during study protocol
  2. * Concomitant medications per SUNRISE1
  3. * Individuals with hepatic impairment
  4. * Female participants who are pregnant or breastfeeding
  5. * Individuals with compromised respiratory function
  6. * Individuals with a history of complex sleep-related behaviour
  7. * Individuals with rare hereditary diseases of galactose intolerance such as galactosemia or glucose-galactose malabsorption
  8. * Individuals with a history of dependence or tolerance - abuse, dependence, rebound insomnia
  9. * Individuals with psychiatric disorders with abnormal thinking and behavioural changes, depression, or suicidal ideation
  10. * Individuals with a diagnosis of narcolepsy

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Duke University
Durham, North Carolina, 27708
United States

Collaborators and Investigators

Sponsor: University of Manitoba

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 Registration Dates

Study Start Date2024-10-29
Study Completion Date2027-04-18

Study Record Updates

Study Start Date2024-10-29
Study Completion Date2027-04-18

Terms related to this study

Additional Relevant MeSH Terms

  • Epilepsy
  • Sleep