Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 5:06 AM
Study NCT ID:
NCT05029960
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-09
First Post:
2021-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerability and Activity of Brivaracetam (BRV) in Patients With Diffuse Gliomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C482793', 'term': 'brivaracetam'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-06', 'studyFirstSubmitDate': '2021-08-25', 'studyFirstSubmitQcDate': '2021-08-25', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of Brivaracetam', 'timeFrame': '6 Months', 'description': 'Evaluate adverse events'}], 'secondaryOutcomes': [{'measure': 'Voluntariness for study participation', 'timeFrame': '6 Months', 'description': 'Number of people that declined to participate'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain Tumor', 'Brivaracetam', 'Epilepsy'], 'conditions': ['Brain Tumor']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the study medication, brivaracetam, is tolerable and safe for patients with brain tumors.', 'detailedDescription': 'In this study, subjects will receive usual treatment for their brain tumor. In addition, they will be given brivaracetam at a dose of 50 mg twice daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years with pathologic diagnosis of a supratentorial diffuse astrocytic or oligodendroglial tumor\n* Patients must be able to provide informed consent\n\nExclusion Criteria:\n\n* A pre-existing seizure disorder or epilepsy syndrome prior to tumor diagnosis\n* Active maintenance therapy with an antiepileptic seizure drug (AED) prior to diagnosis of tumor\n* Patients who have experienced an epileptic seizure as the presenting symptom of their brain tumor\n* Predicted life expectancy of less than 6 months from the time of screening\n* Pregnancy\n* Patients with clinically significant hepatic disease (elevated aminotransferases \\[bilirubin, alkaline phosphatase\\] \\> 3 times upper limit normal)\n* Patients with stage 4 or greater renal disease (GFR \\<30 mL/min/1.73 m2)\n* Patients who are unable to swallow a tablet\n* Patients with active suicidal ideation or a history of suicide attempt or other serious psychiatric disorder having required hospitalization within the previous 2 years.'}, 'identificationModule': {'nctId': 'NCT05029960', 'briefTitle': 'Tolerability and Activity of Brivaracetam (BRV) in Patients With Diffuse Gliomas', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Tolerability and Activity of Brivaracetam (BRV) in Patients With Diffuse Gliomas', 'orgStudyIdInfo': {'id': 'UBRT21074'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Brivaracetam at a dose of 50 mg twice daily for 6 months', 'interventionNames': ['Drug: Brivaracetam']}], 'interventions': [{'name': 'Brivaracetam', 'type': 'DRUG', 'description': 'Dose of 50 mg twice daily for 6 months', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor - Department of Neurology , Epilepsy (SMD)', 'investigatorFullName': 'Thomas Wychowski', 'investigatorAffiliation': 'University of Rochester'}}}}