Preventing first seizures with levetiracetam in patients with motor cortex brain metastases
A Phase II Randomized Open-Label Trial of Levetiracetam for Prevention of Seizures in Patients With Brain Metastases in Primary Motor Cortex
This test will try giving levetiracetam to adults with motor cortex brain metastases who have never had a seizure to see if it prevents a first seizure compared with not giving the drug.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07130786 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with biopsy-proven solid tumor brain metastasis ≥0.5 cm located in the primary motor cortex who have never had a seizure, have a Karnofsky score ≥60, an estimated survival of at least 3–6 months, and are not taking anti-seizure medications.
Not a fit: Patients with prior seizures, an allergy to levetiracetam, metastases outside the primary motor cortex, or who are already taking therapeutic doses of anti-seizure medications are unlikely to qualify or benefit from this intervention.
Why it matters
Potential benefit: If successful, prophylactic levetiracetam could reduce the risk of a first seizure and help preserve function and quality of life for affected patients.
How similar studies have performed: Routine prophylactic anti-seizure medication for seizure‑naïve patients with brain metastases lacks strong randomized evidence, and while levetiracetam is commonly used and well tolerated, randomized data in this exact setting are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.