Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT03539393
Status:
AVAILABLE
Last Update Posted:
2025-07-23
First Post:
2018-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fremanezumab Compassionate Use Program for Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Canada', 'Czechia', 'Italy', 'Spain', 'Sweden', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000604315', 'term': 'fremanezumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}, 'nPtrsToThisExpAccNctId': 3}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2018-05-15', 'studyFirstSubmitQcDate': '2018-05-15', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': "This is a Compassionate Use Program (CUP) based on a licensed physician's unsolicited request. Specifically, this CUP is for male and female pediatric patients 6 to 17 years with a diagnosis of either episodic or chronic migraine who have successfully completed the Teva sponsored study TV48125-CNS-30084 (SPACE study).", 'detailedDescription': 'Patients must have successfully completed the clinical trial according to the 30084 protocol, without any major protocol violations or tolerability issues, or who are anticipated to complete this trial within the next 2months, and whose Requesting/Treating Physician is requesting continued supply of the investigational medicinal product (IMP) known as TEV-48125 (fremanezumab) on behalf of the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible patients may enter this CUP after successfully completing TV48125-CNS-30084 and all End of Study procedures\n* In the opinion of your physician/investigator are able to continue IMP (fremanezumab) in a safe and compliant way.\n\nExclusion Criteria:\n\n* Additional criteria may apply, please contact your physician/investigator for more information.'}, 'identificationModule': {'nctId': 'NCT03539393', 'briefTitle': 'Fremanezumab Compassionate Use Program for Pediatric Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'Fremanezumab (TEV-48125) Compassionate Use Program for Pediatric Patients (6 to 17 Years) With Chronic or Episodic Migraine', 'orgStudyIdInfo': {'id': 'TV48125-CNS-80005'}, 'secondaryIdInfos': [{'id': 'TV48125-MH-80011', 'type': 'OTHER', 'domain': 'Sponsor'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Fremanezumab', 'type': 'DRUG', 'otherNames': ['TEV-48125'], 'description': "For patients who enter this program, the monthly dose of fremanezumab to be administered will be confirmed or adjusted, as appropriate, based on the patient's weight every 3 months."}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Teva Medical Expert, MD', 'role': 'CONTACT', 'email': 'USMedInfo@tevapharm.com', 'phone': '1-888-483-8279'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}