Recruiting
Phase 2

Levetiracetam

Sponsor:

Ayal A. Aizer, MD

Code:

NCT07130786

Conditions

Seizures

Primary Motor Cortex

Brain Metastases From Non-small Cell Lung Cancer (NSCLC)

Brain Metastases, Adult

Brain Metastases From Extra-cranial Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Levetiracetam (Keppra)

Study Details

Brief 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.

Conditions

Seizures

Primary Motor Cortex

Brain Metastases From Non-small Cell Lung Cancer (NSCLC)

Brain Metastases, Adult

Brain Metastases From Extra-cranial Solid Tumors

Study ID

NCT07130786

Start date

Dec 23, 2025

Status verified date

Aug, 2026

Completion date

Feb, 2030

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Prophylactic Levetiracetam

Levetiracetam Anti-Seizure Medication

no intervention: No Prophylactic Levetiracetam

No Anti-Seizure Medication

Interventions

Levetiracetam (Keppra)

Patients will be randomized to receive levetiracetam/ASM or to receive no ASM therapy

Primary outcome measure

  • Seizure Rate [ Time Frame: Duration of time on study (estimated 1 year) ]

Central Contacts and Locations

Central contacts

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

More Information

Sponsor

Ayal A. Aizer, MD

Last update posted

Sep 8, 2026

Last verified

Aug, 2026

Keywords

  • brain metastases
  • seizure
  • levetiracetam
  • seizure-naive
  • keppra
  • motor
  • primary motor cortex
  • motor strip
  • prophylaxis
  • Anti-Seizure Medication
  • ASM
  • SRS
  • SRT
  • necrosis
  • local recurrence
  • quality of life
  • focal aware
  • focal impaired awareness
  • focal to bilateral tonic clonic
  • generalized
  • focal preserved consciousness
  • focal impaired consciousness
  • FPC
  • FIC
  • FTBC
  • tonic
  • clonic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ayal A. Aizer, MD on 2026-09-08.