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NCT06262594PHASE3Recruiting

Lemborexant Treatment of Insomnia Linked to Epilepsy

University of Manitoba

Start Date

10/29/2024

Completion Date

4/18/2027

Summary

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

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Lemborexant

DRUG

Placebo

Interested in This Trial?

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Conditions

EpilepsySleep

Locations

Duke University

Durham, North Carolina 27708

United States

Health Sciences Centre

Winnipeg, Manitoba R3A1R9

Canada