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NCT07271966

B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy

Sponsor: Duke University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-03-30

Completion Date

2027-05-31

Last Updated

2026-02-20

Healthy Volunteers

Conditions

Brain Tumor Related Epilepsy (BTRE)

Interventions

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.

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