B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy

This is a supportive care study to assess the effect of Vitamin B6 supplementation on mood-related side effects of levetiracetam in patients with brain tumors, who have already been prescribed levetiracetam for the prevention of seizures. This study will assess this effect from the perspective of both the patient and the patient's caregiver. Patients will receive Vitamin B6 as a supplement to take daily for 8 to 12 weeks, in addition to the already prescribed levetiracetam and will undergo study assessments as well as complete self-reported questionnaires to evaluate their mood during the course of the study. Additionally, each patient will be asked to optionally identify a designated caregiver, who will complete questionnaires assessing the patient's mood changes, at the same time interval as the patient.

NCT Number	NCT07271966
Lead Sponsor	Duke University
Conditions	Brain Tumor Related Epilepsy (BTRE)
Enrollment	50 participants
Start Date	2026-05-29
Primary Completion	2027-05-31 (estimated)
Study Completion	2028-05-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-29