Preventing first seizures with levetiracetam in patients with motor cortex brain metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with biopsy-proven solid tumor metastases located in the primary motor cortex who are seizure‑naïve will be randomized to prophylactic levetiracetam or to no anti-seizure medication, which reflects current standard care. This is a Phase 2 randomized trial that will track new-onset seizures, adverse effects, and impacts on function and quality of life. Levetiracetam (Keppra) is the anti-seizure medication being tested for primary prophylaxis in this high‑risk cortical location. The study is conducted at Dana‑Farber/Brigham and Women's Hospital and enrolls patients who meet predefined performance status and survival estimates.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants must have a biopsy proven solid malignancy with at least one intracranial lesion radiographically consistent with or pathologically proven to be a brain metastasis located in the primary motor cortex measuring 0.5 cm or larger in maximal unidimensional size
2. Age of at least 18 years
3. Karnofsky performance status of at least 60
4. Estimated survival of at least 3-6 months in the opinion of the enrolling clinician and/or study PI
5. 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

Exclusion Criteria:

1. Participants with prior seizures as this is a study for seizure naïve patients
2. Participants with an allergy to levetiracetam as levetiracetam is the prophylactic anti-seizure medication under study
3. Participants concurrently taking (i.e. at enrollment) an ASM for non-seizure indications at clinically relevant doses (gabapentin 1800 mg/day or higher, pregabalin 300 mg/ day or higher, lamotrigine 150 mg/ day or higher, valproic acid 1000 mg/ day or higher, topiramate 200 mg/ day or higher, carbamazepine 200 mg/ day or higher, oxcarbazepine 300 mg/ day or higher, primidone 100 mg/day or higher) because use of these medications could bias the study toward the null
4. Participants who cannot tolerate a magnetic resonance imaging (MRI) study of the brain, which is required to determine the presence of and follow the course of brain metastases under study
5. Participants who cannot receive gadolinium as MRI of the brain with contrast is required
6. Participants with end stage renal disease due to risk of nephrogenic systemic fibrosis in this patient population after exposure to gadolinium-based contrast agents
7. Participants with widespread, definitive leptomeningeal disease given that leptomeningeal disease and brain metastases are different entities
8. Pregnant women are excluded from this study because levetiracetam crosses the placenta. In addition, the potential deleterious effects of gadolinium on the developing fetus are not completely known
9. Women who are breastfeeding are excluded from this study because levetiracetam enters breast milk. In addition, the potential deleterious effects of gadolinium in breast milk remain unknown

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Ayal A Aizer, MD, MHS — Dana-Farber/Brigham and Women's Cancer Center
• Study coordinator: Ayal A Aizer, MD, MHS
• Email: aaaizer@partners.org
• Phone: (617) 732-7560

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.