Prophylactic Anti-Seizure Medication vs No Anti-Seizure Medication for Patients With Primary 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
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2025
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2025
CompletedFirst Posted
Study publicly available on registry
August 19, 2025
CompletedStudy Start
First participant enrolled
December 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2030
March 19, 2026
March 1, 2026
3.1 years
August 4, 2025
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Seizure Rate
To determine whether seizure rate is lower in seizure-naïve patients with brain metastases in primary motor cortex with levetiracetam prophylaxis versus usual care of no ASM therapy.
Duration of time on study (estimated 1 year)
Secondary Outcomes (15)
Overall survival
Duration of time on study (estimated 1 year)
Death due to neurologic disease progression
Duration of time on study (estimated 1 year)
Progression free survival
Duration of time on study (estimated 1 year)
Performance status
Duration of time on study (estimated 1 year)
Time to detection of new brain metastases
Duration of time on study (estimated 1 year)
- +10 more secondary outcomes
Study Arms (2)
Prophylactic Levetiracetam
EXPERIMENTALLevetiracetam Anti-Seizure Medication
No Prophylactic Levetiracetam
NO INTERVENTIONNo Anti-Seizure Medication
Interventions
Patients will be randomized to receive levetiracetam/ASM or to receive no ASM therapy
Eligibility Criteria
You may qualify if:
- 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
- Age of at least 18 years
- Karnofsky performance status of at least 60
- 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
You may not qualify if:
- Participants with prior seizures as this is a study for seizure naïve patients
- Participants with an allergy to levetiracetam as levetiracetam is the prophylactic anti-seizure medication under study
- 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
- 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
- Participants who cannot receive gadolinium as MRI of the brain with contrast is required
- Participants with end stage renal disease due to risk of nephrogenic systemic fibrosis in this patient population after exposure to gadolinium-based contrast agents
- Participants with widespread, definitive leptomeningeal disease given that leptomeningeal disease and brain metastases are different entities
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ayal A. Aizer, MDlead
- Dana-Farber Cancer Institutecollaborator
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ayal A Aizer, MD, MHS
Dana-Farber/Brigham and Women's Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director, Central Nervous System Radiation Oncology; Associate Professor, Harvard Medical School
Study Record Dates
First Submitted
August 4, 2025
First Posted
August 19, 2025
Study Start
December 23, 2025
Primary Completion (Estimated)
February 1, 2029
Study Completion (Estimated)
February 1, 2030
Last Updated
March 19, 2026
Record last verified: 2026-03