Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
26 participants
INTERVENTIONAL
2024-10-29
2027-04-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Placebo First
0mg
Lemborexant
Drug is administered
Placebo
Drug is administered
Investigational Product First
10mg qhs
Lemborexant
Drug is administered
Placebo
Drug is administered
Interventions
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Lemborexant
Drug is administered
Placebo
Drug is administered
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Contraception
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Duke University
OTHER
University of Manitoba
OTHER
Responsible Party
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Locations
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Duke University
Durham, North Carolina, United States
Health Sciences Centre
Winnipeg, Manitoba, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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L'ÉTOILE
Identifier Type: -
Identifier Source: org_study_id
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