A Study to Evaluate the Safety of DAYVIGO (Lemborexant) Tablets in Participants With Insomnia.
NCT ID: NCT04573556
Last Updated: 2022-04-05
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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COMPLETED
550 participants
OBSERVATIONAL
2020-10-17
2022-03-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Lemborexant
Participants with insomnia will initiate treatment with lemborexant 5 milligram (mg), tablet, orally as per the clinical judgment of the treating physician as part of routine clinical care. Dosage and administration of lemborexant tablet will be according to package insert and actual dosing and frequency will be decided by physician including dose escalation from initial dose of 5 mg up to 10 mg once daily. All participants will be observed prospectively for up to 24 weeks.
Lemborexant
Lemborexant oral tablets.
Interventions
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Lemborexant
Lemborexant oral tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants who provide consent for participation in the study
3. Participants who were registered in EDC by 14 days after DAYVIGO treatment initiation
Exclusion Criteria
2. Participants who were participating in a clinical trial at the time of this study
100 Years
ALL
No
Sponsors
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Eisai Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Eisai trial site 1
Nagoya, , Japan
Eisai trial site 2
Osaka, , Japan
Eisai trial site 3
Tokyo, , Japan
Countries
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Other Identifiers
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E2006-M081-501
Identifier Type: -
Identifier Source: org_study_id
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