Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-29 @ 7:21 PM
Study NCT ID:
NCT04437004
Status:
AVAILABLE
Last Update Posted:
2020-06-18
First Post:
2020-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004831', 'term': 'Epilepsies, Myoclonic'}], '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': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'treatment': True}}, 'statusModule': {'overallStatus': 'AVAILABLE', 'statusVerifiedDate': '2020-06', 'lastUpdateSubmitDate': '2020-06-16', 'studyFirstSubmitDate': '2020-02-21', 'studyFirstSubmitQcDate': '2020-06-16', 'lastUpdatePostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Dravet Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to (1) provide access to fenfluramine for patients with intractable epilepsy associated with Dravet syndrome, and (2) evaluate the safety of fenfluramine.', 'detailedDescription': 'The purpose of this research study is to (1) provide access to fenfluramine for patients with intractable epilepsy associated with Dravet syndrome, and (2) evaluate the safety of fenfluramine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Genetic diagnosis of Dravet syndrome with intractable seizures despite failing all available medications for seizures.'}, 'identificationModule': {'nctId': 'NCT04437004', 'acronym': 'Dravet', 'briefTitle': 'Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol)', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol)', 'orgStudyIdInfo': {'id': 'ZX008-1800'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fenfluramine', 'type': 'DRUG', 'otherNames': ['Fenfluramine Hydrochloride'], 'description': 'The treatment plan for this Expanded Access Protocol is for patients with Dravet syndrome who do not qualify for participation in one of the ongoing ZX008 (fenfluramine hydrochloride) clinical trials.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-1752', 'city': 'Los Angeles', 'state': 'California', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Shaun Hussain, MD', 'role': 'CONTACT', 'phone': '310-206-4037'}, {'name': 'Angela L. Martinez', 'role': 'CONTACT', 'email': 'angelamartinez@mednet.ucla.edu', 'phone': '310-206-4037'}], 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Angela Martinez', 'role': 'CONTACT', 'email': 'angelamartinez@mednet.ucla.edu', 'phone': '310-206-4037'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Shaun Hussain, MD', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}