Brivaracetam for Brain Tumor

Overseen By Thomas Wychowski

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Rochester

Must not be taking: Antiepileptic drugs

Disqualifiers: Seizure disorder, Pregnancy, Hepatic disease, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the medication brivaracetam is safe and tolerable for individuals with certain brain tumors. Participants take brivaracetam as a pill twice daily for six months to assess its effects on the body. The trial seeks adults diagnosed with specific brain tumors (supratentorial diffuse astrocytic or oligodendroglial tumors) who have not experienced seizures before their tumor diagnosis and are not on seizure medications. Participants must be able to provide their own consent and should not have severe liver or kidney problems. As an Early Phase 1 trial, this research aims to understand how brivaracetam works in people, offering participants a chance to be among the first to receive this treatment.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on active maintenance therapy with an antiepileptic seizure drug before your tumor diagnosis.

Is there any evidence suggesting that brivaracetam is likely to be safe for humans?

Research has shown that brivaracetam is usually well-tolerated by patients. One study found that patients with conditions like brain tumors who took brivaracetam experienced fewer seizures, suggesting the medication could be effective and safe, particularly for those with epilepsy related to brain tumors. Another study confirmed this, demonstrating that brivaracetam worked well for patients with various health issues, including brain tumors, and was well-tolerated.

This trial is in an early phase, so there is limited safety data specifically for brain tumor patients. However, since brivaracetam is already approved for treating epilepsy, it indicates some level of safety in humans. Each person's experience may vary, and this trial aims to learn more about its safety for brain tumor patients specifically. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Brivaracetam is unique because it targets specific pathways in the brain to potentially improve outcomes for brain tumor patients, unlike the standard options that typically include surgery, radiation, and chemotherapy. Most treatments for brain tumors focus on directly removing or shrinking the tumor, but Brivaracetam, traditionally an anti-seizure medication, works differently by stabilizing electrical activity in the brain. Researchers are excited about this treatment because it offers a novel approach by reducing tumor-related seizures and possibly enhancing quality of life for patients.

What evidence suggests that brivaracetam might be an effective treatment for brain tumors?

Research has shown that brivaracetam, the investigational treatment in this trial, may help treat seizures caused by brain tumors. In some studies, up to 83.3% of patients with these seizures became seizure-free after 12 months of treatment. Additionally, brivaracetam significantly reduced seizures, with over 35% of patients experiencing at least a 50% decrease in seizure frequency. Early lab studies suggest that brivaracetam might also help fight cancer by stopping cancer cells from growing and spreading. While these results are promising, more research is needed to confirm its effectiveness and safety specifically for brain tumors. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7466736/

Effect of Brivaracetam on Efficacy and Tolerability in Patients ... Conclusion: Our results showed that BRV could be a new therapeutic option effective in reducing seizures in BTRE patients, taking into account ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11633701/

BRIVA‐ONE study: 12‐month outcomes of brivaracetam ... The percentage of seizure‐free patients at 3, 6, and 12 months was 75%, 77.8% and 83.3%, respectively, in those with brain‐tumor related ...

3. link.springer.com link.springer.com/article/10.1007/s00415-024-12253-z

Effectiveness and tolerability of brivaracetam in patients ... At 12 months, ≥ 50% seizure reduction was achieved in 35.6% and 37.4% of patients with and without CLD, respectively (mFAS) (Fig. 1a); seizure ...

4. jeccr.biomedcentral.com jeccr.biomedcentral.com/articles/10.1186/s13046-017-0546-9

In vitro antineoplastic effects of brivaracetam and lacosamide ... Brivaracetam and lacosamide showed a dose-dependent cytotoxic and anti-migratory effects. Cytotoxicity was not related to apoptosis.

5. surgonco.ru surgonco.ru/jour/article/view/857?locale=en_US

The Effect of Treatment for Epilepsy Associated with ... Brivaracetam has shown high efficacy in cancer patients as an additional line of therapy for uncontrolled focal seizures, while a fairly low incidence of ...

6. withpower.com withpower.com/trial/early-phase-1-brain-neoplasms-11-2021-cf918

Brivaracetam for Brain Tumor · Info for Participants Brivaracetam. Trial Overview The study is testing the tolerability and safety of Brivaracetam, a medication potentially useful for patients with brain tumors.

7. researchgate.net researchgate.net/publication/343739019_Effect_of_Brivaracetam_on_Efficacy_and_Tolerability_in_Patients_With_Brain_Tumor-Related_Epilepsy_A_Retrospective_Multicenter_Study

(PDF) Effect of Brivaracetam on Efficacy and Tolerability in ... A retrospective multicenter study of 33 patients with brain tumors of heterogenous pathologies reported seizure freedom in 60% at mean follow-up ...