Vitamin B6 Tested for Mood Side Effects of Levetiracetam in Brain Tumor Epilepsy
Tests vitamin B6 for mood side effects of levetiracetam in adults with brain tumor-related epilepsy.
Plain-language title generated from the registry record
Registry title: B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy
Key facts
- Where
- Durham, United StatesSee the site
Where in United States
- Duke University Medical CenterDurham, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Duke University
- Trial code
- NCT07271966
- Record updated
- 29 July 2026
- Original description
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.Read full original descriptionShow less
B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy (BALANCE)
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.
Inclusion: 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; Signed ICF approved by the institutional review board (IRB); Age ≥ 18 years; Patient has indicated that it is acceptable to recruit their caregivers into the study; Able to read and write English; Has access to e-mail where they can receive electronic ICF and questionnaires; Signed ICF approved by the IRB.
Exclusion: Active prescription for steroids at the time of enrollment; 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; Prior history of gastric surgery or colectomy; Prior history of autoimmune disease, such as Crohn's, Ulcerative Colitis, or Celiac disease; Refractory epilepsy requiring second or third line anti-seizure medication in addition to levetiracetam at the time of enrollment; Patients with a pre-existing history of neuropathy; Known history of Vitamin B6 toxicity or deficiency; Cognitive impairment that affects the patient's ability to comprehend and provide responses to questionnaires; Prescription for extended-release levetiracetam; Patients who are currently pregnant or breastfeeding/chestfeeding; Prescribed Theophylline (Aquaphyllin, Elixophyllin, Theolair, Truxophyllin) used in the treatment of asthma, chronic bronchitis, and emphysema.