Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-02-25 @ 4:47 PM
Study NCT ID:
NCT05870735
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-23
First Post:
2023-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Discovering Factors in Narcolepsy Patients' Clinical Research Experiences
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009290', 'term': 'Narcolepsy'}], 'ancestors': [{'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}, {'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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-12', 'size': 68102, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-05-12T10:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-12', 'studyFirstSubmitDate': '2023-05-12', 'studyFirstSubmitQcDate': '2023-05-12', 'lastUpdatePostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients who decide to enroll in a narcolepsy clinical study.', 'timeFrame': '3 months'}, {'measure': 'Number of narcolepsy study participants who remain in clinical trial until completion.', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Narcolepsy'], 'conditions': ['Narcolepsy']}, 'referencesModule': {'references': [{'pmid': '36098936', 'type': 'BACKGROUND', 'citation': 'Fietze I, Bassetti CLA, Mayleben DW, Pain S, Seboek Kinter D, McCall WV. Efficacy and Safety of Daridorexant in Older and Younger Adults with Insomnia Disorder: A Secondary Analysis of a Randomised Placebo-Controlled Trial. Drugs Aging. 2022 Oct;39(10):795-810. doi: 10.1007/s40266-022-00977-4. Epub 2022 Sep 13.'}, {'pmid': '31324898', 'type': 'BACKGROUND', 'citation': 'Bassetti CLA, Adamantidis A, Burdakov D, Han F, Gay S, Kallweit U, Khatami R, Koning F, Kornum BR, Lammers GJ, Liblau RS, Luppi PH, Mayer G, Pollmacher T, Sakurai T, Sallusto F, Scammell TE, Tafti M, Dauvilliers Y. Narcolepsy - clinical spectrum, aetiopathophysiology, diagnosis and treatment. Nat Rev Neurol. 2019 Sep;15(9):519-539. doi: 10.1038/s41582-019-0226-9. Epub 2019 Jul 19.'}, {'pmid': '24830461', 'type': 'BACKGROUND', 'citation': 'Leschziner G. Narcolepsy: a clinical review. Pract Neurol. 2014 Oct;14(5):323-31. doi: 10.1136/practneurol-2014-000837. Epub 2014 May 15.'}]}, 'descriptionModule': {'briefSummary': 'An observational trial can provide a platform for patients to share experiences and perspectives on living with narcolepsy, which can inform the development of new treatments and support programs.\n\nOverall, an observational clinical trial is an important tool for advancing the understanding of narcolepsy and improving outcomes for patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are actively considering involvement in an observational narcolepsy trial, but have not yet completed enrollment and registration.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is at least 18 years of age\n* Patient is able and willing to comply with the treatment/follow-up schedule and requirements\n* Patient must provide written informed consent\n\nExclusion Criteria:\n\n* Women who are pregnant, intend to become pregnant, or are lactating\n* Inability to perform regular electronic reporting\n* Participants who are vulnerable to any intervention'}, 'identificationModule': {'nctId': 'NCT05870735', 'briefTitle': "Discovering Factors in Narcolepsy Patients' Clinical Research Experiences", 'organization': {'class': 'INDUSTRY', 'fullName': 'Power Life Sciences Inc.'}, 'officialTitle': 'The Patient Voice in Narcolepsy Clinical Trials: Reflections on Experiences and Outcomes', 'orgStudyIdInfo': {'id': '90685891'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Michael B Gill', 'role': 'CONTACT', 'email': 'bask@withpower.com', 'phone': '415-900-4227'}], 'overallOfficials': [{'name': 'Michael B Gill', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Power Life Sciences Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Power Life Sciences Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}