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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Ayal A Aizer, MD, MHS
aaaizer@partners.org
(617) 732-7560
Backup
Ivy B Ricca, BA
iricca@mgb.org
(617) 582-8927
Time Frame
Start Date: 2025-12-23
Estimated Completion Date: 2030-02
Participants
Target number of participants: 150
Treatments
Experimental: Prophylactic Levetiracetam
Levetiracetam Anti-Seizure Medication
No_intervention: No Prophylactic Levetiracetam
No Anti-Seizure Medication
Sponsors
Leads: Ayal A. Aizer, MD
Collaborators: Dana-Farber Cancer Institute

This content was sourced from clinicaltrials.gov