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
Conditions
EpilepsySleep
Locations
Duke University
Durham, North Carolina 27708
United States
Health Sciences Centre
Winnipeg, Manitoba R3A1R9
Canada