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

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

Study Overview

• Status: Terminated
• Conditions: Brain Tumor
• Intervention / Treatment: Drug: Brivaracetam

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Brivaracetam at a dose of 50 mg twice daily for 6 months	Drug: Brivaracetam; Dose of 50 mg twice daily for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Brivaracetam	Evaluate adverse events	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Voluntariness for study participation	Number of people that declined to participate	6 Months

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2022
• Primary Completion (Actual): May 9, 2024
• Study Completion (Actual): May 9, 2024

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Epilepsy; Brain Tumor; Brivaracetam
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms; Epilepsy; Anticonvulsants; brivaracetam
• Other Study ID Numbers: UBRT21074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes