B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy (NCT07271966) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy
50 participantsStarted 2026-05-29
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 years
✓. Diagnosed with a primary brain tumor
✓. Karnofsky Performance Status ≥ 70%
✓. Have one or more documented seizures or transient events concerning for localization-related epilepsy requiring anti-seizure medication prophylaxis
✓. Have an active immediate release levetiracetam prescription
✓. Taking levetiracetam for ≥ 6 weeks and ≤ 6 months before screening
✓. Baseline patient-reported mood symptoms and/or National Comprehensive Cancer Network distress thermometer score ≥ 3
✓. Has access to e-mail where they can receive electronic informed consent form (ICF) and questionnaires
Exclusion criteria
✕. Active prescription for steroids at the time of enrollment
✕. Prescription for extended-release levetiracetam
What they're measuring
1
Efficacy of VitB6 supplementation on LEV-associated mood changes in patients with BTRE, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) anger questionnaire
Timeframe: From enrollment (Baseline) to follow-up at 8-12 weeks from the initiation of VitB6 supplementation
✕. Previous history of suicidal ideation, homicidal ideation, hallucinations, psychosis, depression leading to hospitalization, or mood disturbance leading to hospitalization
✕. Prior history of alcohol use disorder or substance use disorder
✕. Refractory epilepsy requiring second or third line anti-seizure medication in addition to levetiracetam at the time of enrollment
✕. Patients who are currently pregnant or breastfeeding/chestfeeding
✕. Patients with a pre-existing history of neuropathy
✕. Known history of Vitamin B6 toxicity or deficiency