Vitamin B6 added to levetiracetam for mood changes in brain tumor patients
Official title: B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy (BALANCE)
Run by Duke University · NCT07271966 · Data updated 2026-11-12
This study tests whether daily Vitamin B6 can help improve mood side effects in adults with brain tumors who are already taking levetiracetam for seizure prevention.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | May 29, 2026 |
| Main results expected | May 31, 2027 |
| Study ends | May 31, 2028 |
| Registry record updated | July 29, 2026 |
| Trial ID | NCT07271966 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with a primary brain tumor who are on levetiracetam for seizure prevention and meet mood/ distress criteria.
✕Probably not a fit
Patients who do not experience mood-related side effects or do not respond to Vitamin B6 may not see benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with primary brain tumors who are on levetiracetam will take 100 mg of Vitamin B6 daily for 8 to 12 weeks in addition to their current medication. The study uses patient and caregiver questionnaires to track mood changes at two timepoints: after enrollment and at about 8 to 12 weeks. Caregivers identified by the patient will also complete mood assessments. The goal is to see if Vitamin B6 supports mood and well-being in this setting.
Why it matters
Potential benefit: If successful, Vitamin B6 could help reduce mood-related side effects for patients taking levetiracetam.
How similar studies have gone: Prior research in similar contexts has explored vitamin supplementation for mood symptoms, with mixed but informative results.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Duke University Medical Center
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Katherine Peters, MD, PhD — Duke University
- Study coordinator: Katherine Peters, MD, PhD
- Email: dukebrain1@duke.edu
- Phone: 919-684-5301
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.