Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-27 @ 12:36 PM
Study NCT ID:
NCT06568367
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2024-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D020178', 'term': 'Sleep Disorders, Circadian Rhythm'}], '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'}, {'id': 'D021081', 'term': 'Chronobiology Disorders'}, {'id': 'D009784', 'term': 'Occupational Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000623308', 'term': 'solriamfetol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 520}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2024-08-21', 'studyFirstSubmitQcDate': '2024-08-21', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline to Week 12 in the mean sleep latency time as measured by the Maintenance of Wakefulness Test (MWT).', 'timeFrame': '12 weeks'}, {'measure': 'Change from Baseline to Week 12 in the Clinical Global Impressions of Severity of Illness (CGI-S) for sleepiness during the night shift.', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Excessive Sleepiness', 'Solriamfetol', 'Sunosi', 'SWD', 'Dopamine norepinephrine reuptake inhibitor', 'Non-stimulant therapy', 'Insomnia', 'Circadian Rhythm Sleep Disorder', 'Trace amine-associated receptor 1 (TAAR1) agonist'], 'conditions': ['Excessive Sleepiness', 'Shift-work Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.SustainSWD.com', 'label': 'SUSTAIN Study Website'}, {'url': 'http://axsome.com', 'label': 'Axsome Therapeutics Website'}]}, 'descriptionModule': {'briefSummary': 'SUSTAIN (Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with excessive sleepiness associated with shift work disorder (SWD).', 'detailedDescription': 'Eligible subjects must meet the International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria for Shift Work Disorder (SWD). Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol titrated to either 150 mg, 300 mg, or placebo once per night shift for 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria for Shift Work Disorder (SWD)\n* Provides written informed consent to participate in the study before the conduct of any study procedures.\n* Male or female, aged 18 to 65 inclusive.\n\nExclusion Criteria:\n\n* Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription.\n* Unable to comply with study procedures.\n* Medically inappropriate for study participation in the opinion of the investigator.'}, 'identificationModule': {'nctId': 'NCT06568367', 'briefTitle': 'Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Axsome Therapeutics, Inc.'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Solriamfetol in Excessive Sleepiness Associated With Shift Work Disorder', 'orgStudyIdInfo': {'id': 'SOL-SWD-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Solriamfetol 150mg', 'description': 'Up to 12 weeks', 'interventionNames': ['Drug: Solriamfetol 150 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Solriamfetol 300mg', 'description': 'Up to 12 weeks', 'interventionNames': ['Drug: Solriamfetol 300 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Up to 12 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Solriamfetol 150 mg', 'type': 'DRUG', 'description': 'Solriamfetol tablets, taken once daily', 'armGroupLabels': ['Solriamfetol 150mg']}, {'name': 'Solriamfetol 300 mg', 'type': 'DRUG', 'description': 'Solriamfetol tablets, taken once daily', 'armGroupLabels': ['Solriamfetol 300mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets, taken once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35055', 'city': 'Cullman', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United 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