Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07130786

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

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
150 (estimated)
Sponsor
Ayal A. Aizer, MD · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
DRUGLevetiracetam (Keppra)Patients will be randomized to receive levetiracetam/ASM or to receive no ASM therapy

Timeline

Start date
2025-12-23
Primary completion
2029-02-01
Completion
2030-02-01
First posted
2025-08-19
Last updated
2026-03-19

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07130786. Inclusion in this directory is not an endorsement.