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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05029960
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Rochester
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Tumor
Additional Details

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.

Arms & Interventions

Arms

Experimental: Experimental

Brivaracetam at a dose of 50 mg twice daily for 6 months

Interventions

Drug: - Brivaracetam

Dose of 50 mg twice daily for 6 months

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Thomas Wychowski

Thomas_Wychowski@URMC.Rochester.edu

585-275-4401

For additional contact information, you can also visit the trial on clinicaltrials.gov.