Lemborexant Treatment of Insomnia Linked to Epilepsy
Recruiting · NCT06262594 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Manitoba
View the official record on ClinicalTrials.gov →Interventions studied
LemborexantPlacebo
What this trial is about
The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed across 1 US state.
- Duke University - Durham, North Carolina, United States
- Health Sciences Centre - Winnipeg, Manitoba, Canada