Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-03-29 @ 7:03 AM
Study NCT ID:
NCT04573556
Status:
COMPLETED
Last Update Posted:
2022-04-05
First Post:
2020-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety of DAYVIGO (Lemborexant) Tablets in Participants With Insomnia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000634104', 'term': 'lemborexant'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 550}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-04', 'studyFirstSubmitDate': '2020-09-29', 'studyFirstSubmitQcDate': '2020-09-29', 'lastUpdatePostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events (AEs) and Adverse Drug Reactions (ADRs)', 'timeFrame': 'Up to 24 Weeks', 'description': 'The adverse events considered by the investigators to be related to treatment with lemborexant will be classified as ADRs. The incidence of somnolence, parasomnia symptoms (nightmare, abnormal dreams, exploding head syndrome etc.), narcoleptic symptoms (sleep paralysis, hypnagogic hallucination, hypnopompic hallucination and cataplexy etc.), and suicidal ideation/suicidal behavior (intentional overdose, self-injurious ideation, suicidal ideation etc.) will be determined.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Response to Treatment', 'timeFrame': 'Up to 24 Weeks', 'description': 'Response to treatment will be assessed by the impression of general improvement consisting of "Improvement", "No change", and "Worsening". One of these ratings will be selected based on physician\'s impression according to participants\' complaints of insomnia symptoms and will be recorded in Electronic Data Capture (EDC).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['E2006', 'Lemborexant', 'Insomnia', 'Non-interventional', 'Dayvigo'], 'conditions': ['Sleep Initiation and Maintenance Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the incidence of somnolence, parasomnia, narcoleptic symptoms, and suicidal ideation/suicidal behavior after administration of lemborexant (DAYVIGO) in daily practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Approximately 300 participants with insomnia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants who are treated with lemborexant\n2. Participants who provide consent for participation in the study\n3. Participants who were registered in EDC by 14 days after DAYVIGO treatment initiation\n\nExclusion Criteria:\n\n1. Participants who were enrolled in this study before obtaining informed consent of this study\n2. Participants who were participating in a clinical trial at the time of this study'}, 'identificationModule': {'nctId': 'NCT04573556', 'briefTitle': 'A Study to Evaluate the Safety of DAYVIGO (Lemborexant) Tablets in Participants With Insomnia.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'Multicenter, Post-marketing Observational (Non-interventional) Study to Evaluate the Safety of DAYVIGO Tablet in Patients With Insomnia.', 'orgStudyIdInfo': {'id': 'E2006-M081-501'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lemborexant', 'description': '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.', 'interventionNames': ['Drug: Lemborexant']}], 'interventions': [{'name': 'Lemborexant', 'type': 'DRUG', 'otherNames': ['E2006', 'DAYVIGO'], 'description': 'Lemborexant oral tablets.', 'armGroupLabels': ['Lemborexant']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nagoya', 'country': 'Japan', 'facility': 'Eisai trial site 1', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Eisai trial site 2', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Eisai trial site 3', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}