B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy (NCT07271966)
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (15 items) and avoid the listed exclusions (13 items).
Location: Duke University Medical Center — Durham, North Carolina
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria for Patients:
- Active prescription for steroids at the time of enrollment
- Prescription for extended-release levetiracetam
- 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
- Prior history of gastric surgery or colectomy
- Prior history of autoimmune disease, such as Crohn's, Ulcerative Colitis, or Celiac disease
- Prescribed Theophylline (Aquaphyllin, Elixophyllin, Theolair, Truxophyllin) used in the treatment of asthma, chronic bronchitis, and emphysema
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Duke University Medical Center — Durham, North Carolina
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.