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

University of Rochester

Status and phase

Active, not recruiting

Early Phase 1

Conditions

Brain Tumor

Treatments

Drug: Brivaracetam

Study type

Interventional

Funder types

Other

Identifiers

NCT05029960

UBRT21074

Details and patient eligibility

About

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

Full description

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.