B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy (BALANCE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Tumor Related Epilepsy (BTRE)
• Intervention / Treatment: Dietary supplement: Vitamin B6 100 MG

Detailed 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 twice per day, for at least 6 weeks and up to 6 months for the prevention of seizures. This study will assess this effect from the perspective of both the patient and the patient's caregiver.

Patients who have been diagnosed with a primary brain tumor and who have been prescribed levetiracetam 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. Patients will undergo study assessments and will complete self-reported questionnaires to evaluate their mood at two different timepoints: one after patient enrollment and the second at the follow-up visit scheduled about 8 to 12 weeks after initiation of VitB6 supplementation .

Additionally, each patient will be asked to identify a designated caregiver, who will complete questionnaires assessing the patient's mood changes at the same time interval as the patient. A caregiver can include any person identified by the patient who is directly involved in their care and support. This includes, but is not limited to, assisting with daily living, meal preparation, transportation, medication management, financial support, coordinating health appointments, and promoting emotional well-being. The identification of a caregiver is optional and is not a requirement for patient participation.

After the patient and their caregiver complete their respective questionnaires, the study will end. Patients may choose to either continue or discontinue taking VitB6 after the study ends.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine Peters, MD, PhD; Phone Number: 919-684-5301; Email: dukebrain1@duke.edu
• Study Contact Backup: Name: Stevie Threatt, MS; Phone Number: 919-684-5301; Email: dukebrain1@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria for Patients:

1. Age ≥ 18 years
2. Diagnosed with a primary brain tumor
3. Karnofsky Performance Status ≥ 70%
4. Have one or more documented seizures or transient events concerning for localization-related epilepsy requiring anti-seizure medication prophylaxis
5. Have an active immediate release levetiracetam prescription
6. Taking levetiracetam for ≥ 6 weeks and ≤ 6 months before screening
7. Baseline patient-reported mood symptoms and/or National Comprehensive Cancer Network distress thermometer score ≥ 3
8. Has access to e-mail where they can receive electronic informed consent form (ICF) and questionnaires
9. Signed ICF approved by the institutional review board (IRB)

Inclusion Criteria for Caregivers:

1. Age ≥ 18 years
2. Patient has indicated that it is acceptable to recruit their caregivers into the study
3. Able to read and write English
4. Has access to e-mail where they can receive electronic ICF and questionnaires
5. Signed ICF approved by the IRB

Exclusion Criteria for Patients:

1. Active prescription for steroids at the time of enrollment
2. Prescription for extended-release levetiracetam
3. Previous history of suicidal ideation, homicidal ideation, hallucinations, psychosis, depression leading to hospitalization, or mood disturbance leading to hospitalization
4. Prior history of alcohol use disorder or substance use disorder
5. Refractory epilepsy requiring second or third line anti-seizure medication in addition to levetiracetam at the time of enrollment
6. Patients who are currently pregnant or breastfeeding/chestfeeding
7. Patients with a pre-existing history of neuropathy
8. Known history of Vitamin B6 toxicity or deficiency
9. Prior history of gastric surgery or colectomy
10. Prior history of autoimmune disease, such as Crohn's, Ulcerative Colitis, or Celiac disease
11. Prescribed Theophylline (Aquaphyllin, Elixophyllin, Theolair, Truxophyllin) used in the treatment of asthma, chronic bronchitis, and emphysema
12. Cognitive impairment that affects the patient's ability to comprehend and provide responses to questionnaires

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin B6 supplementation	Dietary supplement: Vitamin B6 100 MG; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Katherine Peters, MD, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Estimated): May 29, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 9, 2025

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Brain tumor; Vitamin B6; Levetiracetam; Katherine Peters; BTRE; Pro00119210
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Picolines; Vitamin B 6
• Other Study ID Numbers: Pro00119210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No