B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy

NCT07271966 | Not Yet Recruiting

• 1 other identifier: Pro00119210
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

BTRE; Vitamin B6; Levetiracetam; Katherine Peters; Pro00119210; Brain tumor

Outcome Measures

Primary Outcomes (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

  Mean change in patient-reported PROMIS anger T-scores between baseline and the 8 to 12-week follow-up visit among patients who complete questionnaires at both timepoints. Each item on the PROMIS Anger Short Form is rated on a 5-point scale. The total score can range from 5 to 25, with higher scores indicating greater severity of anger.

  From enrollment (Baseline) to follow-up at 8-12 weeks from the initiation of VitB6 supplementation

Study Arms (1)

Vitamin B6 supplementation

EXPERIMENTAL

Dietary Supplement: Vitamin B6 100 MG

Interventions

Vitamin B6 100 MG DIETARY_SUPPLEMENT

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.

Vitamin B6 supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Cognitive impairment that affects the patient's ability to comprehend and provide responses to questionnaires

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Vitamin B 6

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Katherine Peters, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Peters, MD, PhD

CONTACT

919-684-5301; dukebrain1@duke.edu

Stevie Threatt, MS

CONTACT

919-684-5301; dukebrain1@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start (Estimated): May 29, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 5, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share