Purpose of this Study
This study includes a screening visit, a treatment period lasting 8 to 12 weeks, and a follow-up. During the screening, you will have a medical exam, and information about your health and background will be collected from your hospital records.
If you qualify and choose to join, you will take Vitamin B6 once a day for 8 to 12 weeks. You and a caregiver will receive study questionnaires electronically. These will be sent within 7 days after you join the study, before you start taking Vitamin B6, and again after your follow-up visit. You will have up to 14 days to complete each set of questionnaires.
There is no special visit at the end of treatment. The study ends once you finish the final set of questionnaires after taking Vitamin B6.
Who Can Participate?
Eligibility
To join this study, people must be 18 years old or older and have been diagnosed with a primary brain tumor. They must have had one or more seizures or similar events that suggest a type of epilepsy needing treatment with anti-seizure medicine.
Participants must be currently taking immediate-release levetiracetam and must have been on it for at least 6 weeks but no more than 6 months before the study begins. They cannot be taking the extended-release version of levetiracetam.
People cannot join if they have epilepsy that does not respond to treatment and requires more than one anti-seizure medicine, or if they have had certain types of stomach or bowel surgery.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is looking at how well Vitamin B6 works to help with mood changes that may happen when people with brain tumor-related epilepsy take a medicine called levetiracetam. These mood changes can include feeling sad, angry, or anxious. The study is part of supportive care, which means it is meant to help people feel better while they are being treated for other health problems. Researchers hope that Vitamin B6 might make these mood changes less severe and improve how people feel overall.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy (BALANCE)
Principal Investigator
Katherine
Peters
Protocol Number
PRO00119210
NCT ID
NCT07271966
Phase
N/A
Enrollment Status
Pending Open to Enrollment