Actively Recruiting
Lemborexant Treatment of Insomnia Linked to Epilepsy
Led by University of Manitoba · Updated on 2025-02-13
26
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Manitoba
Lead Sponsor
D
Duke University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether Lemborexant can improve sleep in adults who have epilepsy, specifically those with sleep-related focal epilepsy. This phase 3 clinical trial focuses on assessing the treatment effect on insomnia linked to epilepsy. The study is led by the University of Manitoba and compares Lemborexant to a placebo in a randomized, triple-blind design. Participants will receive either Lemborexant or a placebo once daily at bedtime. The study includes two groups: one that receives a placebo first and another that receives Lemborexant first, with the drug administered orally at a dose of 10 mg at night. The trial will monitor participants over 36 days to measure sleep improvements. During the study, participants will be monitored for their wake after sleep onset (WASO) time as the primary outcome. Researchers will assess sleep patterns and safety while ensuring participants do not change antiseizure medications during the trial. The involvement will include regular evaluations to track sleep quality and any side effects, with a focus on maintaining stable epilepsy treatment throughout the study period.
CONDITIONS
Brief Title
Lemborexant Treatment of Insomnia Linked to Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of sleep-related focal epilepsy
- Use of contraception for participants as applicable
You will not qualify if you...
- Changes in antiseizure medication within 1 month before or during the study
- Use of certain concomitant medications as specified by SUNRISE1
- Hepatic impairment
- Pregnancy or breastfeeding
- Compromised respiratory function
- History of complex sleep-related behaviour
- Rare hereditary diseases of galactose intolerance such as galactosemia or glucose-galactose malabsorption
- History of dependence, tolerance, abuse, or rebound insomnia
- Psychiatric disorders with abnormal thinking, behavioural changes, depression, or suicidal ideation
- Diagnosis of narcolepsy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 36 days
Participants receive either Lemborexant or placebo to evaluate the treatment of insomnia linked to epilepsy.
Multiple visits during each treatment period as scheduled by the study
Trial Site Locations
Total: 2 locations
1
Duke University
Durham, North Carolina, United States, 27708
Not Yet Recruiting
2
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A1R9
Actively Recruiting
Research Team
M
Marcus C Ng, MD, FRCPC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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