This clinical trial evaluates whether vitamin B6 supplementation improves levetiracetam-associated mood side effects in patients taking levetiracetam for brain tumor related epilepsy. Seizures are a common and debilitating complication of primary brain tumors. Thus, anti-seizure medications like levetiracetam are initiated after the first seizure according to recommendations. Mood-related side effects such as agitation, irritability, depression, and insomnia may occur while patients are on levetiracetam, leading to medication discontinuation or transition to an alternative medication. Some research has shown that vitamin B6 supplementation may reduce these side effects in pediatric epilepsy patients. Vitamin B6 is a vitamin naturally occurring in certain food groups. It affects cognitive development through the production of chemicals like serotonin and dopamine. Vitamin B6 may improve mood-related side effects in patients taking levetiracetam for brain tumor related epilepsy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07271966.
Locations matching your search criteria
United States
North Carolina
Durham
Duke University Medical CenterStatus: Active
Contact: Katherine Barnett Peters
Phone: 919-684-5301
PRIMARY OBJECTIVE:
I. To evaluate the efficacy of pyridoxine hydrochloride (VitB6) supplementation on levetiracetam (LEV)-associated mood changes in patients with brain tumor related epilepsy (BTRE), as measured by the patient-reported Patient-Reported Outcomes Measurement Information System (PROMIS) anger questionnaire.
EXPLORATORY OBJECTIVES:
I. To explore changes in patient-reported mood symptoms, as measured by the patient-reported PROMIS anxiety questionnaire, at baseline and follow-up.
II. To explore changes in patient mood symptoms as perceived by the caregiver, as measured by the PROMIS-irritability-Parent/Guardian short form (addendum for adults), at baseline and follow-up.
III. To explore the correlation between changes in mood symptoms as reported by the patient and perceived by the caregiver using the PROMIS questionnaires.
IV. To explore clinical or sociodemographic factors that may be predictive of LEV-associated mood changes in patients with primary BTRE who receive VitB6 supplementation.
V. To explore clinical or sociodemographic factors that may be predictive of baseline mood changes in patients with primary BTRE.
OUTLINE:
Patients receive VitB6 orally (PO) once daily (QD) for 8 to 12 weeks in the absence of unacceptable toxicity.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDuke University Medical Center
Principal InvestigatorKatherine Barnett Peters
