NCT07130786 Prophylactic Anti-Seizure Medication vs No Anti-Seizure Medication for Patients With Primary Motor Cortex Brain Metastases
| NCT ID | NCT07130786 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ayal A. Aizer, MD |
| Condition | Seizures |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-12-23 |
| Primary Completion | 2029-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2025-12-23 with a primary completion date of 2029-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Ayal A Aizer, MD, MHS
PRINCIPAL INVESTIGATOR
Dana-Farber/Brigham and Women's Cancer Center
Frequently Asked Questions
Who can join the NCT07130786 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Seizures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07130786 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07130786 currently recruiting?
Yes, NCT07130786 is actively recruiting participants. Contact the research team at aaaizer@partners.org for enrollment information.
Where is the NCT07130786 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07130786 clinical trial?
NCT07130786 is sponsored by Ayal A. Aizer, MD. The principal investigator is Ayal A Aizer, MD, MHS at Dana-Farber/Brigham and Women's Cancer Center. The trial plans to enroll 150 participants.