Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
Study NCT ID:
NCT06413433
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2024-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056912', 'term': 'Binge-Eating Disorder'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': 450}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2024-05-09', 'studyFirstSubmitQcDate': '2024-05-09', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline to Week 12 in number of binge eating episodes', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Binge eating disorder', 'BED', 'Solriamfetol', 'Sunosi', 'Axsome', 'Non-stimulant therapy', 'Dopamine norepinephrine reuptake inhibitor', 'Trace amine-associated receptor 1 (TAAR1) agonist'], 'conditions': ['Binge-Eating Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.axsome.com', 'label': 'Axsome Therapeutics Website'}, {'url': 'https://www.EngageBED.com', 'label': 'ENGAGE Study Website'}]}, 'descriptionModule': {'briefSummary': 'ENGAGE (Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of binge eating disorder (BED) in adults.', 'detailedDescription': 'Eligible subjects must have a diagnosis of BED according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol (150 or 300 mg) or placebo, once daily for 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary diagnosis of BED according to DSM-5 criteria.\n* Provides written informed consent to participate in the study before the conduct of any study procedures.\n* Male or female, aged 18 to 55 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': 'NCT06413433', 'acronym': 'ENGAGE', 'briefTitle': 'Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Axsome Therapeutics, Inc.'}, 'officialTitle': 'A Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder (BED)', 'orgStudyIdInfo': {'id': 'SOL-BED-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Solriamfetol 150 mg', 'description': 'Up to 12 weeks', 'interventionNames': ['Drug: Solriamfetol 150 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Solriamfetol 300 mg', '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 150 mg']}, {'name': 'Solriamfetol 300 mg', 'type': 'DRUG', 'description': 'Solriamfetol tablets, taken once daily', 'armGroupLabels': ['Solriamfetol 300 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets, taken once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91316', 'city': 'Encino', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Clinical Research Site', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92103', 'city': 'San 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