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

Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05029960
• Other study ID #: UBRT21074
• Status: Recruiting
• Phase: Early Phase 1
• Start date: May 17, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: University of Rochester
• Contact: Thomas Wychowski
• Phone: 585-275-4401
• Email: Thomas_Wychowski[@]URMC.Rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

Intervention

Drug:
• Brivaracetam
Dose of 50 mg twice daily for 6 months

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Brivaracetam	Evaluate adverse events	6 Months
Secondary	Voluntariness for study participation	Number of people that declined to participate	6 Months