NCT07271966Recruiting
B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy
B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy (BALANCE)
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 26 Nov 2025
- Start date
- 29 May 2026
- Primary completion date
- 31 May 2027
- Lead sponsor
- Duke University
- Diseases
- Epilepsy
- NCT number
- NCT07271966
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 29 May 2026 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active prescription for steroids at the time of enrollment
- Previous history of suicidal ideation, homicidal ideation, hallucinations, psychosis, depression leading to hospitalization, or mood disturbance leading to hospitalization
- Prior history of alcohol use disorder or substance use disorder
- Prior history of gastric surgery or colectomy
- Prior history of autoimmune disease, such as Crohn's, Ulcerative Colitis, or Celiac disease
Other illness
- Refractory epilepsy requiring second or third line anti-seizure medication in addition to levetiracetam at the time of enrollment
- Patients with a pre-existing history of neuropathy
- Known history of Vitamin B6 toxicity or deficiency
- Cognitive impairment that affects the patient's ability to comprehend and provide responses to questionnaires
Other
- Prescription for extended-release levetiracetam
- Patients who are currently pregnant or breastfeeding/chestfeeding
- Prescribed Theophylline (Aquaphyllin, Elixophyllin, Theolair, Truxophyllin) used in the treatment of asthma, chronic bronchitis, and emphysema
Who the study is looking for
- Age ≥ 18 years
- Diagnosed with a primary brain tumor
- Karnofsky Performance Status ≥ 70%
- Have one or more documented seizures or transient events concerning for localization-related epilepsy requiring anti-seizure medication prophylaxis
- Have an active immediate release levetiracetam prescription
- Taking levetiracetam for ≥ 6 weeks and ≤ 6 months before screening
- Baseline patient-reported mood symptoms and/or National Comprehensive Cancer Network distress thermometer score ≥ 3
- Has access to e-mail where they can receive electronic informed consent form (ICF) and questionnaires
- Signed ICF approved by the institutional review board (IRB)
- Age ≥ 18 years
- Patient has indicated that it is acceptable to recruit their caregivers into the study
- Able to read and write English
- Has access to e-mail where they can receive electronic ICF and questionnaires
- Signed ICF approved by the IRB
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.