Brivaracetam for Brain Tumor

Overseen By Thomas Wychowski

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Rochester

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for adults over 18 with a specific type of brain tumor (diffuse astrocytic or oligodendroglial). Participants must be able to consent and not have had seizures before their diagnosis, nor can they be on seizure drugs. They should expect to live more than 6 months, not be pregnant, and have no severe liver or kidney disease.

Inclusion Criteria

Patients must be able to provide informed consent

I am over 18 and have been diagnosed with a specific brain tumor.

Exclusion Criteria

Pregnancy

My first sign of a brain tumor was a seizure.

I cannot swallow pills.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive brivaracetam at a dose of 50 mg twice daily for 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Brivaracetam

Trial Overview The study is testing the tolerability and safety of Brivaracetam, a medication potentially useful for patients with brain tumors. It aims to see if people can handle the drug without significant issues.

Participant Groups

Group I: Experimental Experimental Treatment 1 Intervention

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

Brivaracetam is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Briviact for:

• Partial-onset seizures with or without secondary generalisation

Approved in United States as Briviact for:

• Focal (partial) onset seizures in epilepsy patients 1 month of age and older

Approved in Canada as Brivlera for:

• Partial-onset seizures with or without secondary generalisation

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+