MedTrace Logo

B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy

NCT07271966 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-05

No results posted yet for this study

Summary

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.

Conditions

  • Brain Tumor Related Epilepsy (BTRE)

Interventions

DIETARY_SUPPLEMENT

Vitamin B6 100 MG

Patients will be prescribed 100 mg of Vitamin B6 as a supplement to take daily in the morning, by mouth for 8 to 12 weeks, in addition to the already prescribed levetiracetam.

Sponsors & Collaborators

Principal Investigators

  • Katherine Peters, MD, PhD · Duke University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-29
Primary Completion
2026-05-31
Completion
2027-05-31

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07271966 on ClinicalTrials.gov