Epilepsy, Sleep
Conditions
Brief summary
The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy.
Interventions
DRUGLemborexant
Drug is administered
DRUGPlacebo
Drug is administered
Sponsors
Duke University
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WASO | 36 Days | Wake After Sleep Onset (recorded using PSG) |
Countries
Canada, United States
Contacts
Primary ContactMarcus C Ng, MD, FRCPC
Outcome results
None listed