Tolerability and Activity of Brivaracetam (BRV) in Patients With Diffuse Gliomas

Conditions: Brain Tumor

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: EARLY_PHASE1

Enrollment: 3

Sponsor: University of Rochester

Location: University of Rochester Medical Center Rochester New York

Summary

The purpose of this study is to determine whether the study medication, brivaracetam, is tolerable and safe for patients with brain tumors.

Eligibility Criteria

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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05029960). StuddyBuddy aggregates publicly available trial information.