Clinical trial · Interventional
B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy
B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy (BALANCE)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor Related Epilepsy (BTRE) | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vitamin B6 100 MG | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vitamin B6 supplementation
- interventionNames
- Dietary Supplement: Vitamin B6 100 MG
Primary outcomes (1)
- 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
- timeFrame
- From enrollment (Baseline) to follow-up at 8-12 weeks from the initiation of VitB6 supplementation
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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