Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-02-25 @ 12:53 AM
Study NCT ID:
NCT06792708
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of LUMRYZ in Narcolepsy
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-01-20', 'studyFirstSubmitQcDate': '2025-01-20', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Narcolepsy Severity Scale', 'timeFrame': 'Baseline to Month 4', 'description': 'Change from the first visit (baseline), prior to start of LUMRYZ, to Month 4; measure of narcolepsy symptom frequency and impact on daily life with total possible score from 0-57 (higher score indicates more frequent and severe symptoms)'}, {'measure': 'Sheehan Disability Scale', 'timeFrame': 'Baseline to Month 4', 'description': 'Change from the first visit (baseline), prior to start of LUMRYZ, to Month 4; measure of disruption to normal activities using a 0-10 scale, along with the number of days missed and/or underproductive at work/school'}, {'measure': 'Patient Global Impression of Change', 'timeFrame': 'Month 4', 'description': 'Measure of improvement at Month 4 using a scale of 1 (very much improved) to 7 (very much worse); scored by patient'}, {'measure': 'Clinical Global Impression of Change', 'timeFrame': 'Month 4', 'description': 'Measure of improvement at Month 4 using a scale of 1 (very much improved) to 7 (very much worse); scored by clinician'}, {'measure': 'Adverse Reactions', 'timeFrame': 'Month 1, Month 2, Month 3, Month 4', 'description': 'Clinician-directed interview for common adverse reactions'}], 'primaryOutcomes': [{'measure': 'Epworth Sleepiness Scale', 'timeFrame': 'Baseline to Month 4', 'description': 'Change from the first visit (baseline), prior to start of LUMRYZ, to Month 4; measure of sleepiness with total possible score of 0-24 (higher score equivalent to higher sleepiness)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Narcolepsy']}, 'descriptionModule': {'briefSummary': 'This is an observational study of LUMRYZ prescribed in clinical practice. Patients are asked if they would be willing to complete questionnaires over a 4-month period after starting LUMRYZ. The questionnaires ask about narcolepsy symptoms, experience with LUMRYZ, and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults (18 years and older) with a diagnosis of Type 1 or Type 2 narcolepsy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with narcolepsy\n* Oxybate naive or prior treatment with twice-nightly oxybate\n* Access to smart phone, tablet or laptop with reliable internet connection\n* Able to read/understand English\n* Written informed consent and ability to comply with schedule\n\nExclusion Criteria:\n\n* Already using LUMRYZ\n* Clinical or mental health condition excluded by LUMRYZ label\n* Any other condition/situation that would adversely impact participation'}, 'identificationModule': {'nctId': 'NCT06792708', 'acronym': 'REFRESH', 'briefTitle': 'Observational Study of LUMRYZ in Narcolepsy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avadel'}, 'officialTitle': 'A Prospective, Multicenter, Observational Study of LUMRYZ Used in Clinical Practice for the Treatment of Narcolepsy', 'orgStudyIdInfo': {'id': 'PMLUM-2402'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients Starting LUMRYZ', 'description': 'The cohort is comprised of patients prescribed LUMRYZ in clinical practice. All dosing decisions are made by the clinician.', 'interventionNames': ['Drug: LUMRYZ']}], 'interventions': [{'name': 'LUMRYZ', 'type': 'DRUG', 'description': 'Prescribed for narcolepsy in accordance with product label.', 'armGroupLabels': ['Patients Starting LUMRYZ']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34209', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Jeremy D McConnell, MD PA', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '48823', 'city': 'East Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Comprehensive Sleep Center', 'geoPoint': {'lat': 42.73698, 'lon': -84.48387}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Patient First MD', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '13057', 'city': 'East Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Ghaly Sleep Management Services', 'geoPoint': {'lat': 43.06534, 'lon': -76.07853}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43017', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Sleep Medicine Institute', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}, {'zip': '19001', 'city': 'Abington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abington Neurological Associates', 'geoPoint': {'lat': 40.12067, 'lon': -75.11795}}, {'zip': '19096', 'city': 'Wynnewood', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pulmonology Associates, Inc.', 'geoPoint': {'lat': 40.00289, 'lon': -75.27074}}, {'zip': '19610', 'city': 'Wyomissing', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Respiratory Specialists', 'geoPoint': {'lat': 40.32954, 'lon': -75.96521}}, {'zip': '29201', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Bogan Sleep Consultants', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '77478', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'Tricoastal Narcolepsy and Sleep Disorder Center', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'zip': '77375', 'city': 'Tomball', 'state': 'Texas', 'country': 'United States', 'facility': 'Northwest Houston Neurology', 'geoPoint': {'lat': 30.09716, 'lon': -95.61605}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avadel', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}