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NCT06262594 Clinical Trial

Lemborexant Treatment of Insomnia Linked to Epilepsy

Epilepsy Clinical Trial

— L'ÉTOILE  

Official title:
Lemborexant Treatment of Insomnia Linked to Epilepsy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06262594
Other study ID # L'ÉTOILE
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 18, 2024
Est. completion date April 18, 2026

Study information
Verified date December 2023
Source University of Manitoba
Contact Marcus C Ng, MD
Phone 204-787-2684
Email letoile@umanitoba.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 26
Est. completion date April 18, 2026
Est. primary completion date April 18, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lemborexant
Drug is administered
• Placebo
Drug is administered

Locations
Country Name City State
Canada Health Sciences Centre Winnipeg Manitoba

Sponsors (2)
Lead Sponsor Collaborator
University of Manitoba Duke University

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary WASO Wake After Sleep Onset (recorded using PSG) 36 Days
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