A Phase 2 interventional study of Levetiracetam (Keppra) in Seizures, Primary Motor Cortex and Brain Metastases From Non-small Cell Lung Cancer (NSCLC), sponsored by Ayal A. Aizer, MD. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Ayal A. Aizer, MD · Phase 2, Interventional, and Supportive care
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.
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.
766 studies on the registry are indexed under Seizures; 136 are open to participants now.
This study's planned enrollment of 150 is above the median of 64 across 519 interventional studies indexed under Seizures.
Browse Seizures studies →Ayal A. Aizer, MD is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Levetiracetam Anti-Seizure Medication
Drug: Levetiracetam (Keppra)
No Anti-Seizure Medication
Patients will be randomized to receive levetiracetam/ASM or to receive no ASM therapy
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.
Time frame: Duration of time on study (estimated 1 year)
Overall survival
Clinical parameter
Time frame: Duration of time on study (estimated 1 year)
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)
Time frame: Duration of time on study (estimated 1 year)
Progression free survival
Clinical assessment time to first progression after baseline
Time frame: Duration of time on study (estimated 1 year)
Performance status
Karnofsky performance status (KPS). Assessed longitudinally. Higher scores on 0-100 scale represent better functional status and less dependence on others.
Time frame: Duration of time on study (estimated 1 year)
Time to detection of new brain metastases
Radiographic assessment showing first appearance of new brain metastases after baseline
Time frame: Duration of time on study (estimated 1 year)
Time to development of radiation necrosis
Radiographic assessment of first appearance of radiation necrosis after baseline
Time frame: Duration of time on study (estimated 1 year)
Time to development of leptomeningeal disease
Radiographic assessment of first appearance of leptomeningeal disease after baseline
Time frame: Duration of time on study (estimated 1 year)
Time to local recurrence
Radiographic assessment of first local recurrence after baseline in brain metastases treated with radiation
Time frame: Duration of time on study (estimated 1 year)
Time to craniotomy
Clinical assessment of first use of neurosurgical resection as salvage therapy after baseline
Time frame: Duration of time on study (estimated 1 year)
Time to radiotherapeutic treatments after initial management
Clinical assessment of first use of salvage brain-directed radiation after baseline
Time frame: Duration of time on study (estimated 1 year)
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.
Time frame: Duration of time on study (estimated 1 year)
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
Time frame: Duration of time on study (estimated 1 year)
Time to seizure
Time to clinical determination of presence of primary seizure after baseline
Time frame: Duration of time on study (estimated 1 year)
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
Time frame: Duration of time on study (estimated 1 year)
Time to secondary seizures
Clinical determination of presence of secondary seizures after baseline
Time frame: Duration of time on study (estimated 1 year)
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Feb 2029, 38 months after the start.
Of 35 phase 2 interventional studies under Seizures, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 58. This study's planned 38 months is close to that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Levetiracetam
Ayal A. Aizer, MD