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

ConditionsSeizures Primary Motor Cortex Brain Metastases From Non-small Cell Lung Cancer (NSCLC)Brain Metastases, Adult Brain Metastases From Extra-cranial Solid Tumors

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorAyal A. Aizer, MD

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Levetiracetam (Keppra)
Drug
Patients will be randomized to receive levetiracetam/ASM or to receive no ASM therapy

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: Prophylactic LevetiracetamExperimental treatment 1 intervention

Group B: No Prophylactic LevetiracetamNo intervention 0 interventions

Trial outcomes

Primary outcomes

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