Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-27 @ 5:01 AM
Study NCT ID:
NCT04289467
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2020-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Refractory Infantile Spasms With Fenfluramine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013036', 'term': 'Spasms, Infantile'}], 'ancestors': [{'id': 'D004829', 'term': 'Epilepsy, Generalized'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000073376', 'term': 'Epileptic Syndromes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005277', 'term': 'Fenfluramine'}], 'ancestors': [{'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2020-02-21', 'studyFirstSubmitQcDate': '2020-02-26', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electroclinical response (Efficacy)', 'timeFrame': '12 months', 'description': 'Number of participants with resolution of epileptic spasms and hypsarrhythmia (if present at baseline) after 21 days of treatment, as determined by overnight video-electroencephalography (EEG) evaluation and caregiver seizure diary.'}], 'secondaryOutcomes': [{'measure': 'Computational electroencephalography response (Efficacy)', 'timeFrame': '12 months', 'description': 'Median and range of response quantified using the probability-weighted response index (PWRI), a novel computational electroencephalography measure of hypsarrhythmia burden.'}, {'measure': 'Incidence of treatment emergent adverse events (Safety and tolerability)', 'timeFrame': '12 months', 'description': 'Detailed accounting of all treatment-emergent adverse events, including number of participants with clinically-significant valvulopathy and/or pulmonary hypertension, as determined by echocardiography.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infantile Spasm']}, 'descriptionModule': {'briefSummary': 'This is a phase II clinical trial in which children with refractory infantile spasms (also called epileptic spasms or West syndrome) will be treated with fenfluramine, to evaluate efficacy, safety, and tolerability. Patients with infantile spasms that have not responded to treatment with vigabatrin and ACTH we will be invited to participate. Study participants will undergo baseline video-EEG, receive treatment with fenfluramine for 21 days, and then undergo repeat video-EEG to determine effectiveness. Patients with favorable response will have the opportunity to continue treatment for up to 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children ages 12 to 36 months, inclusive\n* Clinical diagnosis of infantile spasms\n* Continued epileptic spasms despite adequate treatment with ACTH and vigabatrin.\n\nExclusion Criteria:\n\n* Significant preexisting cardiovascular disease\n* Exposure to any cannabinoid product within 14 days of screening\n* Initiation or dose-titration of any second-line treatment for infantile spasms in the 14 days prior to screening.\n* Implantation of a vagal nerve simulator within 14 days of screening\n* Initiation and maintenance of the ketogenic diet within 3 months of screening'}, 'identificationModule': {'nctId': 'NCT04289467', 'briefTitle': 'Treatment of Refractory Infantile Spasms With Fenfluramine', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Orange County"}, 'officialTitle': 'A Phase II Study of Fenfluramine for Treatment of Refractory Infantile Spasms', 'orgStudyIdInfo': {'id': 'ZX008-IS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fenfluramine treatment', 'description': 'Open label treatment with fenfluramine. Dosage will be titrated to 0.8 mg/kg/day, for an initial duration of 21 days. Patients with favorable response will have an option to continue treatment for up to 6 months.', 'interventionNames': ['Drug: Fenfluramine']}], 'interventions': [{'name': 'Fenfluramine', 'type': 'DRUG', 'otherNames': ['Fenfluramine Hydrochloride'], 'description': 'Open-label', 'armGroupLabels': ['Fenfluramine treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Angela L. Martinez', 'role': 'CONTACT', 'email': 'angelamartinez@mednet.ucla.edu', 'phone': '310-206-7630'}, {'name': 'Shaun A Hussain, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCLA Health', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daniel Shrey, MD', 'role': 'CONTACT', 'email': 'dshrey@choc.org'}, {'name': 'Angelyque Lorenzana', 'role': 'CONTACT', 'email': 'alorenzana@choc.org', 'phone': '714-509-8972'}], 'facility': "Children's Hospital of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'centralContacts': [{'name': 'Angelyque Lorenzana, MA', 'role': 'CONTACT', 'email': 'alorenzana@choc.org', 'phone': '714-509-8972'}, {'name': 'Virginia Allhusen, PhD', 'role': 'CONTACT', 'email': 'vallhusen@choc.org'}], 'overallOfficials': [{'name': 'Daniel Shrey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Orange County"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Orange County", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Daniel Shrey', 'investigatorAffiliation': "Children's Hospital of Orange County"}}}}