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Recruiting Phase 3 NCT06262594

Lemborexant Treatment of Insomnia Linked to Epilepsy

Trial Parameters

Condition Epilepsy
Sponsor University of Manitoba
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 26
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-10-29
Completion 2026-04-18
All Conditions
Interventions
LemborexantPlacebo

Brief Summary

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

Eligibility Criteria

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

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