Lemborexant for Insomnia Linked to Epilepsy

This study is looking at whether Lemborexant can help people with epilepsy who also have trouble sleeping (insomnia). You might be able to join if you are an adult (18 or older) with sleep-related focal epilepsy and use contraception. However, you cannot participate if you've recently changed your epilepsy medication, are pregnant or breastfeeding, have liver problems, or have breathing issues. The researchers will measure how well Lemborexant works by looking at how much time you spend awake after falling asleep (WASO) over 36 days. The study is currently unclear about its recruitment status.

Study design
This interventional study plans to enroll 26 participants. It compares Lemborexant to a placebo (an inactive substance).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 36 days, suggesting follow-up for at least this duration.

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NCT06262594

Lemborexant Treatment of Insomnia Linked to Epilepsy

Recruiting
PHASE3Ages 18+InterventionalTreatment
University of Manitoba
~26 participants
Updated 2025-02-13 on ClinicalTrials.gov
What's tested:LemborexantPlacebo

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
WASO
Measured over 36 Days
Epilepsy
Sleep
2 sites across 2 states
North Carolina1
Manitoba1

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Eligibility criteria

Inclusion

Sleep-related focal epilepsy
Contraception

Exclusion

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
  • WASO36 Days

    Wake After Sleep Onset (recorded using PSG)