B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy

Conditions

• Brain Tumor Related Epilepsy (BTRE)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

First listed

Dec 9, 2025

Start date

May 29, 2026

Status verified

Nov 2025

Primary completion

May 31, 2027

Completion

May 31, 2028

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Vitamin B6 supplementation

Primary Outcome Measure

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 [ Time Frame: From enrollment (Baseline) to follow-up at 8-12 weeks from the initiation of VitB6 supplementation ]

Central Contacts

• Katherine Peters, MD, PhD
  919-684-5301
  [email protected]
• Stevie Threatt, MS
  919-684-5301
  [email protected]

Locations (1)

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