Brain Tumor
Conditions
Keywords
Brain Tumor, Brivaracetam, Epilepsy
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.
Interventions
DRUGBrivaracetam
Dose of 50 mg twice daily for 6 months
Sponsors
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Brivaracetam | 6 Months | Evaluate adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Voluntariness for study participation | 6 Months | Number of people that declined to participate |
Countries
United States
Outcome results
None listed