Lemborexant Treatment of Insomnia Linked to Epilepsy

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

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Sleep

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Health Sciences Centre, Winnipeg, Manitoba, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lemborexant

Drug

Drug is administered

Other names: Dayvigo

Placebo

Drug

Drug is administered

Primary outcomes

WASO

Time frame: 36 Days

Wake After Sleep Onset (recorded using PSG)

Study contacts

Contact information is provided by the study sponsor or research team.

Marcus C Ng, MD, FRCPC

CONTACT

[email protected]

204-787-2684

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

Duke University

Registry information

Acronym: L'ÉTOILE

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2027
First posted: Feb 16, 2024
Registry last updated: Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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