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

Recruiting
18 years of age
Both
Phase N/A

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Overview

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

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.

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.

Study details

Brain Tumor

NCT05029960

University of Rochester

25 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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