Back to resultsTolerability and Activity of Brivaracetam (BRV) in Patients With Diffuse Gliomas
Primary Purpose
Brain Tumor
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Brivaracetam
Sponsored by
About this trial
This is an interventional treatment trial for Brain Tumor focused on measuring Brain Tumor, Brivaracetam, Epilepsy
Eligibility Criteria
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.
Sites / Locations
- University of Rochester Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Brivaracetam at a dose of 50 mg twice daily for 6 months
Outcomes
Primary Outcome Measures
Safety of Brivaracetam
Evaluate adverse events
Secondary Outcome Measures
Voluntariness for study participation
Number of people that declined to participate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05029960
Brief Title
Tolerability and Activity of Brivaracetam (BRV) in Patients With Diffuse Gliomas
Official Title
Tolerability and Activity of Brivaracetam (BRV) in Patients With Diffuse Gliomas
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor
Keywords
Brain Tumor, Brivaracetam, Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Brivaracetam at a dose of 50 mg twice daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Brivaracetam
Intervention Description
Dose of 50 mg twice daily for 6 months
Primary Outcome Measure Information:
Title
Safety of Brivaracetam
Description
Evaluate adverse events
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Voluntariness for study participation
Description
Number of people that declined to participate
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Wychowski
Phone
585-275-4401
Email
Thomas_Wychowski@URMC.Rochester.edu
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Tolerability and Activity of Brivaracetam (BRV) in Patients With Diffuse Gliomas
We'll reach out to this number within 24 hrs