Prophylactic Anti-Seizure Medication vs No Anti-Seizure Medication for Patients With Primary Motor Cortex Brain Metastases

Last updated: March 17, 2026
Sponsor: Ayal A. Aizer, MD
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasm Metastasis

Treatment

Levetiracetam (Keppra)

Clinical Study ID

NCT07130786
25-189
  • Ages > 18
  • All Genders

Study Summary

This is a randomized trial for patients with brain metastases in the primary motor cortex who have not had seizures to receive either the prophylactic anti-seizure medication levetiracetam (also known by its trade name Keppra) or proceed with standard of care management, which does not currently include prophylactic levetiracetam. Patients who enroll to this trial will be randomized to receive prophylactic levetiracetam or not receive prophylactic levetiracetam.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants must have a biopsy proven solid malignancy with at least oneintracranial lesion radiographically consistent with or pathologically proven to bea brain metastasis located in the primary motor cortex measuring 0.5 cm or larger inmaximal 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 clinicianand/or study PI

  5. Ability to understand and the willingness to sign a written informed consentdocument by either ink on paper or a DF/HCC approved eConsent medium

Exclusion

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 prophylacticanti-seizure medication under study

  3. Participants concurrently taking (i.e. at enrollment) an ASM for non-seizureindications 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/ dayor 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 thebrain, which is required to determine the presence of and follow the course of brainmetastases under study

  5. Participants who cannot receive gadolinium as MRI of the brain with contrast isrequired

  6. Participants with end stage renal disease due to risk of nephrogenic systemicfibrosis in this patient population after exposure to gadolinium-based contrastagents

  7. Participants with widespread, definitive leptomeningeal disease given thatleptomeningeal disease and brain metastases are different entities

  8. Pregnant women are excluded from this study because levetiracetam crosses theplacenta. In addition, the potential deleterious effects of gadolinium on thedeveloping fetus are not completely known

  9. Women who are breastfeeding are excluded from this study because levetiracetamenters breast milk. In addition, the potential deleterious effects of gadolinium inbreast milk remain unknown

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Levetiracetam (Keppra)
Phase: 2
Study Start date:
December 23, 2025
Estimated Completion Date:
February 28, 2030

Study Description

Brain metastases (BrM) impact 10%-40% of patients with solid malignancies and are associated with significant clinical sequelae, including development of seizures. The development of seizures has the potential for significant detriment on patient quality of life. The goal of this study is to evaluate the role of levetiracetam as primary prophylaxis in seizure-naïve patients with metastases in primary motor cortex, an area at high risk of seizures. Patients will be randomized to receive levetiracetam/ASM or to receive no ASM therapy.

Connect with a study center

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

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