Overview

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

Status:
Not yet recruiting
Trial end date:
2022-12-31
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether the study medication, brivaracetam, is tolerable and safe for patients with brain tumors.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Rochester
Treatments:
Brivaracetam
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 <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.