Brain Tumor Related Epilepsy (BTRE)BALANCENCT07271966
B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy
A study testing Vitamin B6 100 MG in people with Brain Tumor Related Epilepsy (BTRE), run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor Related Epilepsy (BTRE)
- What is being tested?
- Vitamin B6 100 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Active prescription for steroids at the time of enrollment
- Prescription for extended-release levetiracetam
- 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
- Refractory epilepsy requiring second or third line anti-seizure medication in addition to levetiracetam at the time of enrollment
- Patients who are currently pregnant or breastfeeding/chestfeeding
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- Patients with a pre-existing history of neuropathy
- Known history of Vitamin B6 toxicity or deficiency
- Prior history of gastric surgery or colectomy
- Prior history of autoimmune disease, such as Crohn's, Ulcerative Colitis, or Celiac disease
- Prescribed Theophylline (Aquaphyllin, Elixophyllin, Theolair, Truxophyllin) used in the treatment of asthma, chronic bronchitis, and emphysema
- Cognitive impairment that affects the patient's ability to comprehend and provide responses to questionnaires
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy (BALANCE)
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.
Read the detailed description
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 twice per day, for at least 6 weeks and up to 6 months for the prevention of seizures. This study will assess this effect from the perspective of both the patient and the patient's caregiver.
Patients who have been diagnosed with a primary brain tumor and who have been prescribed levetiracetam 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. Patients will undergo study assessments and will complete self-reported questionnaires to evaluate their mood at two different timepoints: one after patient enrollment and the second at the follow-up visit scheduled about 8 to 12 weeks after initiation of VitB6 supplementation .
Additionally, each patient will be asked to identify a designated caregiver, who will complete questionnaires assessing the patient's mood changes at the same time interval as the patient. A caregiver can include any person identified by the patient who is directly involved in their care and support. This includes, but is not limited to, assisting with daily living, meal preparation, transportation, medication management, financial support, coordinating health appointments, and promoting emotional well-being. The identification of a caregiver is optional and is not a requirement for patient participation.
After the patient and their caregiver complete their respective questionnaires, the study will end. Patients may choose to either continue or discontinue taking VitB6 after the study ends.
- Conditions
- Brain Tumor Related Epilepsy (BTRE)
- Being tested
- Vitamin B6 100 MG
- Keywords
- BTRE, Vitamin B6, Levetiracetam, Katherine Peters, Pro00119210, Brain tumor
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B6 100 MGDietary 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 group | Role | What they receive |
|---|---|---|
| Vitamin B6 supplementation | Experimental | Not described Receives: Dietary Supplement: Vitamin B6 100 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: From enrollment (Baseline) to follow-up at 8-12 weeks from the initiation of VitB6 supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start29 May 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Tumor Related Epilepsy (BTRE)Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Peters, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271966
- Sponsor's protocol ID
- Pro00119210
- Acronym
- BALANCE
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy (BALANCE)
- ClinicalTrials.gov ID
- NCT07271966
- Acronym / sponsor ID
- BALANCE / Pro00119210
- Conditions
- Brain Tumor Related Epilepsy (BTRE)
- Keywords
- BTRE, Vitamin B6, Levetiracetam, Katherine Peters, Pro00119210, Brain tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 29 May 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 twice per day, for at least 6 weeks and up to 6 months for the prevention of seizures. This study will assess this effect from the perspective of both the patient and the patient's caregiver.
Patients who have been diagnosed with a primary brain tumor and who have been prescribed levetiracetam 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. Patients will undergo study assessments and will complete self-reported questionnaires to evaluate their mood at two different timepoints: one after patient enrollment and the second at the follow-up visit scheduled about 8 to 12 weeks after initiation of VitB6 supplementation .
Additionally, each patient will be asked to identify a designated caregiver, who will complete questionnaires assessing the patient's mood changes at the same time interval as the patient. A caregiver can include any person identified by the patient who is directly involved in their care and support. This includes, but is not limited to, assisting with daily living, meal preparation, transportation, medication management, financial support, coordinating health appointments, and promoting emotional well-being. The identification of a caregiver is optional and is not a requirement for patient participation.
After the patient and their caregiver complete their respective questionnaires, the study will end. Patients may choose to either continue or discontinue taking VitB6 after the study ends.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin B6 supplementation | Experimental | Dietary Supplement: Vitamin B6 100 MG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (12 listed)
- Active prescription for steroids at the time of enrollment
- Prescription for extended-release levetiracetam
- 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
- Refractory epilepsy requiring second or third line anti-seizure medication in addition to levetiracetam at the time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin B6 100 MGPatients 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. | Dietary supplement | Vitamin B6 supplementation |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine Peters, MD, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin B6 100 MG in people with Brain Tumor Related Epilepsy (BTRE), run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine Peters, MD, PhD (919-684-5301, dukebrain1@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.