Background:
Buspirone is a drug that is approved for the treatment of anxiety in adults. Studies suggest
that buspirone might act on parts of the brain that can increase certain levels of brain
activity. Increasing this brain activity may help decrease epileptic seizures that come from
certain parts of the brain. Researchers want to see if buspirone can reduce seizure frequency
in people with seizures who are already taking antiseizure medication.
Objectives:
To test whether buspirone can reduce the frequency of seizures in people whose seizures seem
to start from one part of the brain.
Eligibility:
Individuals between 18 and 65 years of age who have seizures coming from one or more places
in the brain.
Participants must have tried at least two different antiseizure medications.
Participants must also have had at least three seizures during a 1-month observation period
while on current medicines.
Design:
Participants will have a screening visit with a physical exam and medical history.
Participants will complete mood and memory testing scales. Blood, urine, and saliva samples
will be collected.
Participants will have a magnetic resonance imaging scan to evaluate brain structures that
relate to epilepsy. They will also have a positron emission tomography scan to look at parts
of the brain that are affected by buspirone.
Participants will start taking a study drug (either buspirone or placebo) twice daily. They
will keep a calendar of seizures and record any side effects. Treatment will be monitored
with clinic visits and blood samples.
After 12 weeks on the study drug, participants will gradually stop taking either the placebo
or buspirone over two weeks. They will stay off the drug for another 2 weeks.
After 2 weeks, participants will start taking a study drug that is the opposite of the one
they had before. They will keep a calendar of seizures and record any side effects. Treatment
will be monitored with clinic visits and blood samples.
After 12 weeks on the study drug, participants will gradually stop taking either the placebo
or buspirone.
Participants will have a final followup visit with additional blood tests, mood and memory
testing scales and imaging studies.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)