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

Early Phase 1

Active, not recruiting

• Conditions: Brain Tumor
• Interventions: Drug: Brivaracetam

• Registration Number: NCT05029960
• Lead Sponsor: University of Rochester

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-08-25
• Study First Posted: 2021-09-01
• Study Start: 2022-05-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Brivaracetam	Brivaracetam at a dose of 50 mg twice daily for 6 months

Primary Outcome Measures

Name	Time	Method
Safety of Brivaracetam	6 Months	Evaluate adverse events

Secondary Outcome Measures

Name	Time	Method
Voluntariness for study participation	6 Months	Number of people that declined to participate

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States