Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-01 @ 6:27 AM
Study NCT ID:
NCT03196934
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2024-02-02
First Post:
2017-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Use of Cannabidiol Oral Solution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069279', 'term': 'Drug Resistant Epilepsy'}], 'ancestors': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002185', 'term': 'Cannabidiol'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'intermediate': True}}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2017-03-21', 'studyFirstSubmitQcDate': '2017-06-20', 'lastUpdatePostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Refractory Epilepsy']}, 'descriptionModule': {'briefSummary': 'To allow subjects who have completed Insys 030 extension study to continue to take Cannabidiol oral solution.', 'detailedDescription': 'To allow subjects who have completed Insys 030 extension study (A multicenter, open-label, flexible dose study to assess the long-term safety of pharmaceutical Cannabidiol Oral Solution as an adjunctive treatment for pediatric subjects with a treatment-resistant seizure disorder who complete INS011-14-029 or Part A of INS011-15-054) to continue to take Cannabidiol oral solution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Completed the Insys 030 protocol\n2. Compliant in drug study procedures\n3. Non-pregnant females of child bearing age, willing to utilize a double-barrier method of birth control during treatment and for 30 days after treatment has ended\n\nExclusion Criteria:\n\n1. Failure to follow study procedures in Insys 030\n2. Pregnant females'}, 'identificationModule': {'nctId': 'NCT03196934', 'briefTitle': 'Expanded Use of Cannabidiol Oral Solution', 'organization': {'class': 'OTHER', 'fullName': 'MultiCare Health System Research Institute'}, 'officialTitle': 'A Multicenter, Open-label, Flexible Dose Study to Assess the Long-term Safety of Pharmaceutical Cannabidiol Oral Solution as an Adjunctive Treatment for Pediatric Subjects With a Treatment-resistant Seizure Disorder Who Complete INS011-14-029 or Part A of INS011-15-054', 'orgStudyIdInfo': {'id': 'MulticareHSRI'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cannabidiol oral solution', 'type': 'DRUG', 'description': 'Cannabidiol; Pharmacological class of drug'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MultiCare Health System Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}