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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05029960
Other study ID # UBRT21074
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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