B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy (BALANCE)

What is the 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.

What is the Condition Being Studied?

Levetiracetam-associated mood changes in patients with brain tumor-related epilepsy.

Who Can Participate in the Study?

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 Group
Adults

What is Involved?

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.

Study Details

Full Title
B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy (BALANCE)
Principal Investigator
Professor of Neurosurgery
Protocol Number
IRB: PRO00119210
NCT: NCT07271966
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
INSTITUTIONAL APPROVAL SIGNOFF
More Information