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

Stopped early · Early Phase 1

Conditions studied: Brain Tumor

In brief

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

Key facts

Study ID

NCT05029960

Run by

University of Rochester

People needed

3

Starts

2022-05-17

Expected to finish

2024-05-09

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years with pathologic diagnosis of a supratentorial diffuse astrocytic or oligodendroglial tumor
• Patients must be able to provide informed consent

You may not qualify if…

• 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.

Where it is running

• University of Rochester Medical Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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