Brain Tumor Clinical Trial
Official title:
Tolerability and Activity of Brivaracetam (BRV) in Patients With Diffuse Gliomas
The purpose of this study is to determine whether the study medication, brivaracetam, is tolerable and safe for patients with brain tumors.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years with pathologic diagnosis of a supratentorial diffuse astrocytic or oligodendroglial tumor - Patients must be able to provide informed consent Exclusion Criteria: - A pre-existing seizure disorder or epilepsy syndrome prior to tumor diagnosis - Active maintenance therapy with an antiepileptic seizure drug (AED) prior to diagnosis of tumor - Patients who have experienced an epileptic seizure as the presenting symptom of their brain tumor - Predicted life expectancy of less than 6 months from the time of screening - Pregnancy - Patients with clinically significant hepatic disease (elevated aminotransferases [bilirubin, alkaline phosphatase] > 3 times upper limit normal) - Patients with stage 4 or greater renal disease (GFR <30 mL/min/1.73 m2) - Patients who are unable to swallow a tablet - Patients with active suicidal ideation or a history of suicide attempt or other serious psychiatric disorder having required hospitalization within the previous 2 years. |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester Medical Center | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of Brivaracetam | Evaluate adverse events | 6 Months | |
Secondary | Voluntariness for study participation | Number of people that declined to participate | 6 Months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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