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SeizuresPhase 2NCT07130786

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

A Phase 2 study testing Levetiracetam (Keppra) in people with Seizures and Primary Motor Cortex, run by Ayal A. Aizer, MD at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Levetiracetam (Keppra)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
23 Dec 2025to Feb 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ayal A Aizer, MD, MHS contact

(617) 732-7560

aaaizer@partners.org

Marciana F Johnson, MPH contact

(617) 582-8335

mjohnson71@mgb.org

United States1 site, 1 recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Ayal A Aizer, MD, MHS, (617) 732-7560, aaaizer@partners.org

    Recruiting

Other trials in United States

About this study

Official title: A Phase II Randomized Open-Label Trial of Levetiracetam for Prevention of Seizures in Patients With Brain Metastases in Primary Motor Cortex

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.

Read the detailed 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.

Being tested
Levetiracetam (Keppra)
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
Medical subject headings
Seizures, Brain Neoplasms, Necrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Levetiracetam (Keppra)Drug

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

Study groups in NCT07130786
Study groupRoleWhat they receive
Prophylactic LevetiracetamExperimentalLevetiracetam Anti-Seizure Medication
Receives: Drug: Levetiracetam (Keppra)
No Prophylactic LevetiracetamNo interventionNo Anti-Seizure Medication

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Duration of time on study (estimated 1 year)

Secondary outcomes (15)

  1. Overall survival

    Clinical parameter

    Measured: Duration of time on study (estimated 1 year)

  2. Death due to neurologic disease progression

    Clinical parameter to be assessed via review of study visits and medical records indicating cause of death (neurologic versus non-neurologic)

    Measured: Duration of time on study (estimated 1 year)

  3. Progression free survival

    Clinical assessment time to first progression after baseline

    Measured: Duration of time on study (estimated 1 year)

  4. Performance status

    Karnofsky performance status (KPS). Assessed longitudinally. Higher scores on 0-100 scale represent better functional status and less dependence on others.

    Measured: Duration of time on study (estimated 1 year)

  5. Time to detection of new brain metastases

    Radiographic assessment showing first appearance of new brain metastases after baseline

    Measured: Duration of time on study (estimated 1 year)

  6. Time to development of radiation necrosis

    Radiographic assessment of first appearance of radiation necrosis after baseline

    Measured: Duration of time on study (estimated 1 year)

  7. Time to development of leptomeningeal disease

    Radiographic assessment of first appearance of leptomeningeal disease after baseline

    Measured: Duration of time on study (estimated 1 year)

  8. Time to local recurrence

    Radiographic assessment of first local recurrence after baseline in brain metastases treated with radiation

    Measured: Duration of time on study (estimated 1 year)

  9. Time to craniotomy

    Clinical assessment of first use of neurosurgical resection as salvage therapy after baseline

    Measured: Duration of time on study (estimated 1 year)

  10. Time to radiotherapeutic treatments after initial management

    Clinical assessment of first use of salvage brain-directed radiation after baseline

    Measured: Duration of time on study (estimated 1 year)

  11. Quality of life/symptom burden and interference

    Questionnaire - MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) - Items assessed on a 0-10 scale with 10 being the highest severity. Cumulative scores with higher values reflect greater interference/severity of symptoms.

    Assessed longitudinally.

    Questionnaire - Quality of Life in Epilepsy Inventory - 31(QOLIE-31)

    • Final score from 0-100 with higher scores reflecting greater quality of life. Higher T scores similarly reflect greater quality of life.

    Assessed longitudinally.

    Measured: Duration of time on study (estimated 1 year)

  12. Seizure type

    Clinical determination of type of seizure (if present) after baseline. Type of seizure: focal preserved consciousness, focal impaired consciousness, focal to bilateral-tonic-clonic, each adjudicated with or without observable manifestations and with semiology incorporated including elementary motor phenomena

    Measured: Duration of time on study (estimated 1 year)

  13. Time to seizure

    Time to clinical determination of presence of primary seizure after baseline

    Measured: Duration of time on study (estimated 1 year)

  14. Seizure rate in the week following brain-directed local therapy such as brain-directed surgery or radiation

    Clinical determination of presence and number of seizure(s) in the week following brain-directed surgery or radiation after baseline

    Measured: Duration of time on study (estimated 1 year)

  15. Time to secondary seizures

    Clinical determination of presence of secondary seizures after baseline

    Measured: Duration of time on study (estimated 1 year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2025
  2. Study start23 Dec 2025
  3. Primary completionFeb 2029 (estimated)
  4. Study completionFeb 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07130786
Sponsor's protocol ID
25-189
Status last verified
Aug 2026
First submitted
4 Aug 2025
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Levetiracetam (Keppra) in people with Seizures and Primary Motor Cortex, run by Ayal A. Aizer, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ayal A Aizer, MD, MHS ((617) 732-7560, aaaizer@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seizure Rate (time frame: Duration of time on study (estimated 1 year)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07130786.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.

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