Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
Study NCT ID:
NCT01533506
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2013-02-28
First Post:
2012-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stiripentol in Dravet Syndrome
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': 'C021092', 'term': 'stiripentol'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'startDateStruct': {'date': '2012-02'}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-02-26', 'studyFirstSubmitDate': '2012-02-09', 'studyFirstSubmitQcDate': '2012-02-14', 'lastUpdatePostDateStruct': {'date': '2013-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['treatment with stiripentol'], 'conditions': ['Dravet Syndrome']}, 'descriptionModule': {'briefSummary': 'The patient has failed all other available agents and has intractable epilepsy due to Dravet Syndrome. Stiripentol is highly efficacious in Dravet Syndrome. The overall goals of therapy with Stiripentol are primarily to significantly reduce the frequency and severity of seizures.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Genetic diagnosis of Dravet syndrome with intractable seizures despite failing all available medications for seizures'}, 'identificationModule': {'nctId': 'NCT01533506', 'briefTitle': 'Stiripentol in Dravet Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Compassionate Use of Stiripentol in Intractable Epilepsy Due to Dravet Syndrome', 'orgStudyIdInfo': {'id': '12-000690'}}, 'armsInterventionsModule': {'interventions': [{'name': 'stiripentol', 'type': 'DRUG', 'otherNames': ['Diacomit'], 'description': 'Stiripentol up to 30 mg/kg/day to control seizures'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Elaine Wirrell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Elaine C. Wirrell', 'investigatorAffiliation': 'Mayo Clinic'}}}}