Lemborexant Treatment of Insomnia Linked to Epilepsy
- Registration Number
- NCT06262594
- Lead Sponsor
- University of Manitoba
- Brief Summary
The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 26
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo First Placebo 0mg Investigational Product First Placebo 10mg qhs Investigational Product First Lemborexant 10mg qhs Placebo First Lemborexant 0mg
- Primary Outcome Measures
Name Time Method WASO 36 Days Wake After Sleep Onset (recorded using PSG)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Duke University
🇺🇸Durham, North Carolina, United States
Health Sciences Centre
🇨🇦Winnipeg, Manitoba, Canada