Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:57 PM
Study NCT ID:
NCT06262594
Status:
RECRUITING
Last Update Posted:
2025-02-13
First Post:
2023-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lemborexant Treatment of Insomnia Linked to Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000634104', 'term': 'lemborexant'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-04-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2023-12-21', 'studyFirstSubmitQcDate': '2024-02-14', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WASO', 'timeFrame': '36 Days', 'description': 'Wake After Sleep Onset (recorded using PSG)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epilepsy', 'Sleep']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sleep-related focal epilepsy\n* Contraception\n\nExclusion Criteria:\n\n* Changes in antiseizure medication 1 month before study protocol or during study protocol\n* Concomitant medications per SUNRISE1\n* Individuals with hepatic impairment\n* Female participants who are pregnant or breastfeeding\n* Individuals with compromised respiratory function\n* Individuals with a history of complex sleep-related behaviour\n* Individuals with rare hereditary diseases of galactose intolerance such as galactosemia or glucose-galactose malabsorption\n* Individuals with a history of dependence or tolerance - abuse, dependence, rebound insomnia\n* Individuals with psychiatric disorders with abnormal thinking and behavioural changes, depression, or suicidal ideation\n* Individuals with a diagnosis of narcolepsy'}, 'identificationModule': {'nctId': 'NCT06262594', 'acronym': "L'ÉTOILE", 'briefTitle': 'Lemborexant Treatment of Insomnia Linked to Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Lemborexant Treatment of Insomnia Linked to Epilepsy', 'orgStudyIdInfo': {'id': "L'ÉTOILE"}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo First', 'description': '0mg', 'interventionNames': ['Drug: Lemborexant', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Investigational Product First', 'description': '10mg qhs', 'interventionNames': ['Drug: Lemborexant', 'Drug: Placebo']}], 'interventions': [{'name': 'Lemborexant', 'type': 'DRUG', 'otherNames': ['Dayvigo'], 'description': 'Drug is administered', 'armGroupLabels': ['Investigational Product First', 'Placebo First']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Drug is administered', 'armGroupLabels': ['Investigational Product First', 'Placebo First']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27708', 'city': 'Durham', 'state': 'North Carolina', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Birgit Frauscher, MD, PhD', 'role': 'CONTACT', 'email': 'birgit.frauscher@duke.edu', 'phone': '919-681-1700'}], 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': 'R3A1R9', 'city': 'Winnipeg', 'state': 'Manitoba', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Marcus Ng, MD, FRCPC', 'role': 'CONTACT', 'email': 'letoile@umanitoba.ca', 'phone': '204-787-2684'}], 'facility': 'Health Sciences Centre', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'centralContacts': [{'name': 'Marcus C Ng, MD, FRCPC', 'role': 'CONTACT', 'email': 'letoile@umanitoba.ca', 'phone': '204-787-2684'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Duke University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}