B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy
Recruiting now · Not applicable
Conditions studied: Brain Tumor Related Epilepsy (BTRE)
In brief
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.
Key facts
- Study ID
- NCT07271966
- Run by
- Duke University
- People needed
- 50
- Starts
- 2026-05-29
- Expected to finish
- 2028-05-31
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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