Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT06413420
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SUNOSI® (Solriamfetol) Pregnancy Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009290', 'term': 'Narcolepsy'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], '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'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000623308', 'term': 'solriamfetol'}, {'id': 'D000697', 'term': 'Central Nervous System Stimulants'}], 'ancestors': [{'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1731}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2029-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-09', 'studyFirstSubmitDate': '2024-05-09', 'studyFirstSubmitQcDate': '2024-05-09', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-term Safety', 'timeFrame': 'Baseline up to 12 months after pregnancy outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Solriamfetol', 'SUNOSI', 'Axsome', 'Narcolepsy', 'Obstructive Sleep Apnea', 'Non-stimulant therapy', 'Dopamine norepinephrine reuptake inhibitor', 'Pregnancy outcomes', 'Infant outcomes'], 'conditions': ['Narcolepsy', 'Obstructive Sleep Apnea', 'Pregnant Women and Their Offspring']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.axsome.com', 'label': 'Axsome Therapeutics Website'}, {'url': 'https://sunosipregnancyregistry.com', 'label': 'Sunosi Pregnancy Registry Recruitment Website'}]}, 'descriptionModule': {'briefSummary': 'The SUNOSI (solriamfetol) Pregnancy Registry is a prospective, multi-country, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep apnea (OSA).', 'detailedDescription': "The goal of the registry is to provide information on the safety of solriamfetol during pregnancy so that patients and physicians can weigh the benefits and risks of exposure during pregnancy and make informed treatment decisions.\n\nThe study collects health information from enrolled pregnant women and their healthcare providers related to their pregnancies and developing babies up to 1 year of age. The registry is strictly observational. Only data that are routinely documented in patients' medical records during the course of usual care will be collected."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include pregnant women of any age who reside in a country where solriamfetol is available for the treatment of narcolepsy or OSA, provide consent to participate as well as medical releases for their healthcare providers (HCPs) to provide data to the registry, and meet the criteria for inclusion into 1 of the 5 cohorts.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women of any age\n* Diagnosed with narcolepsy or obstructive sleep apnea OR has taken solriamfetol or other wake promoting medications or stimulants during pregnancy\n* Resident of a country where solriamfetol is available for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy or OSA\n* Provides written informed consent to participate in the study\n* Authorization for her HCP(s) to provide data to the registry\n\nExclusion Criteria:\n\n* Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC)\n* Inclusion of a prior pregnancy in the main analysis population'}, 'identificationModule': {'nctId': 'NCT06413420', 'briefTitle': 'SUNOSI® (Solriamfetol) Pregnancy Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Axsome Therapeutics, Inc.'}, 'officialTitle': 'SUNOSI® (Solriamfetol) Pregnancy Registry: An Observational Study on the Safety of Solriamfetol Exposure in Pregnant Women and Their Offspring', 'orgStudyIdInfo': {'id': 'JZP110-402'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA', 'description': 'Pregnant women with a diagnosis of narcolepsy or OSA', 'interventionNames': ['Drug: Sunosi (solriamfetol)']}, {'label': 'Cohort 2: Unexposed participants with narcolepsy or OSA', 'description': 'Pregnant women with a diagnosis of narcolepsy or OSA', 'interventionNames': ['Other: No treatment']}, {'label': 'Cohort 3: Other-exposed participants with narcolepsy or OSA', 'description': 'Pregnant women with a diagnosis of narcolepsy or OSA', 'interventionNames': ['Drug: Other prescription wake-promoting medications or stimulants']}, {'label': 'Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA', 'description': 'Pregnant women without a diagnosis of narcolepsy or OSA', 'interventionNames': ['Drug: Sunosi (solriamfetol)']}, {'label': 'Cohort 5: Other-exposed participants without narcolepsy or OSA', 'description': 'Pregnant women without a diagnosis of narcolepsy or OSA', 'interventionNames': ['Drug: Other prescription wake-promoting medications or stimulants']}], 'interventions': [{'name': 'Sunosi (solriamfetol)', 'type': 'DRUG', 'description': 'Exposure to at least 1 dose of solriamfetol at any time during pregnancy.', 'armGroupLabels': ['Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA', 'Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA']}, {'name': 'Other prescription wake-promoting medications or stimulants', 'type': 'DRUG', 'description': 'Exposure to at least 1 dose of a prescription wake-promoting medication or stimulant at any time during pregnancy.', 'armGroupLabels': ['Cohort 3: Other-exposed participants with narcolepsy or OSA', 'Cohort 5: Other-exposed participants without narcolepsy or OSA']}, {'name': 'No treatment', 'type': 'OTHER', 'description': 'No treatment', 'armGroupLabels': ['Cohort 2: Unexposed participants with narcolepsy or OSA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27560', 'city': 'Morrisville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Evidera, a PPD business unit', 'geoPoint': {'lat': 35.82348, 'lon': -78.82556}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'PPD, Inc.', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}], 'centralContacts': [{'name': 'Study Director', 'role': 'CONTACT', 'email': 'sunosipregnancyregistry@ppd.com', 'phone': '1-877-283-6220'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Axsome Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}