Levetiracetam for Seizures in Brain Cancer

AA
IB
Overseen ByIvy B Ricca, BA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if levetiracetam, an anti-seizure medication, can prevent seizures in individuals with brain cancer in the primary motor cortex who have not previously experienced seizures. Participants will either receive levetiracetam or continue their usual care routine without it. This trial suits those with brain metastasis in the primary motor cortex who have not had seizures. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

If you are currently taking certain anti-seizure medications at specific doses, you may not be eligible to participate in this trial. The trial does not specify if you need to stop other medications, so it's best to discuss your current medications with the study team.

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

Research has shown that levetiracetam, a medication used to prevent seizures, is generally well-tolerated by people with brain tumors. Studies have found it usually has fewer side effects than other seizure medications. For example, a review of several studies found that levetiracetam effectively prevents seizures and is considered safe.

However, it's important to remember that while levetiracetam appears promising, some studies suggest more research is needed to fully understand its safety and effectiveness. Overall, current evidence suggests that levetiracetam is a safe choice for managing seizures in people with brain tumors.12345

Why do researchers think this study treatment might be promising for seizures?

Levetiracetam is unique because it specifically targets seizures in patients with brain cancer, offering a new approach to managing this challenging condition. Unlike other anti-seizure medications that primarily work by altering neurotransmitter levels, levetiracetam is believed to modulate synaptic vesicle proteins, which may lead to fewer side effects. Researchers are excited about its potential to provide effective seizure control with a potentially better safety profile, making it a promising option for improving the quality of life for brain cancer patients.

What evidence suggests that levetiracetam might be an effective treatment for seizures in brain cancer?

Research has shown that levetiracetam can help prevent seizures in people with brain tumors. Studies have found that this medication reduces the number of seizures after surgery in these patients. In one large study, many patients stopped having seizures while using levetiracetam. Another study showed that 94% of patients with brain tumors had their seizures under control with this medication. In this trial, participants will receive either prophylactic levetiracetam or no anti-seizure medication to evaluate its effectiveness in reducing seizures for brain tumor patients.13567

Who Is on the Research Team?

AA

Ayal A Aizer, MD, MHS

Principal Investigator

Dana-Farber/Brigham and Women's Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with brain metastases located in the primary motor cortex who haven't had seizures. It's not clear what specific conditions exclude someone from participating, as the exclusion criteria are not provided.

Inclusion Criteria

Estimated survival of at least 3-6 months in the opinion of the enrolling clinician and/or study PI
Ability to understand and the willingness to sign a written informed consent document by either ink on paper or a DF/HCC approved eConsent medium
I am 18 years old or older.
See 2 more

Exclusion Criteria

I cannot have MRI contrast agents like gadolinium.
I have never had a seizure.
I am not allergic to levetiracetam.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either prophylactic levetiracetam or no anti-seizure medication

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Levetiracetam
Trial Overview The study is testing whether taking levetiracetam (Keppra) can prevent seizures in these patients compared to standard care without this medication. Participants will be randomly assigned to either receive Keppra or follow standard care.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Prophylactic LevetiracetamExperimental Treatment1 Intervention
Group II: No Prophylactic LevetiracetamActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ayal A. Aizer, MD

Lead Sponsor

Citations

Efficacy and safety of levetiracetam in preventing ...Prophylactic levetiracetam decreases the frequency of postoperative seizures, particularly early postoperative seizures, in individuals with brain tumor.
Study protocol of short versus long-term levetiracetam in brain ...The trial will provide level 1 evidence on the optimal duration of ASM use in primary brain tumors with a history of seizures.
Seizure-Freedom-With-Levetiracetam-Therapy-in-Brain ...This is the largest retrospective study to date that demonstrates excellent seizure freedom rates using LEV for patients with brain tumors. The ...
The efficacy of levetiracetam for patients with supratentorial ...Our results show that LEV is an effective AED for seizure control in brain tumor patients. The subanalysis revealed a CR rate of 94% for LEV during the ...
Levetiracetam Prophylaxis Therapy for Brain Tumor ...Data in the literature highlight that LEV is associated with a favorable outcome in BTRE with a consistent reduction in seizure frequency (4, 8) ...
Association between survival and levetiracetam use in ...LEV use was associated with prolonged survival in patients with GBM treated with concurrent TMZ chemoradiotherapy.
Efficacy and safety of prophylactic levetiracetam in ...Moreover, levetiracetam use demonstrates fewer side effects in brain tumour patients. Nevertheless, high risk of bias and moderate methodological quality must ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security