Lemborexant Treatment of Insomnia Linked to Epilepsy

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Epilepsy, Sleep

In brief

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

Key facts

Study ID

NCT06262594

Run by

University of Manitoba

People needed

26

Starts

2024-10-29

Expected to finish

2027-04-18

Last updated by the study team

2025-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Sleep-related focal epilepsy
• Contraception

You may not qualify if…

• 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

Where it is running

• Health Sciences Centre — Winnipeg, Manitoba, Canada (enrolling)
• Duke University — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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