Aurora St. Luke’s Medical Center in Milwaukee is the first site in Wisconsin to join a global clinical trial that is testing an investigational drug to treat a neurological condition called focal epilepsy.
“People with focal epilepsy experience spontaneous focal seizures, which are surges of electrical activity that start in a small part of the brain but may spread and may be clinically reflected in the opposite side of the body,” said Veronica Sosa, MD, a neurologist and Advocate Aurora Research Institute’s principal investigator for the study. “Seizures can present in complex ways that may include motor, sensory, cognitive or perceptual changes in a patient. They may also be silent or without obvious signs, what are referred to as subclinical seizures.”
This clinical trial is evaluating whether an oral medication can safely reduce the frequency of focal seizures, which account for about 60% of seizures in people with epilepsy, according to the National Institute of Neurological Disorders and Stroke.
“Over time, uncontrolled seizures from epilepsy can lead to memory problems and other cognitive issues, as well as an increased likelihood of mood disorders,” Dr. Sosa said. “Unfortunately, focal seizures can be very difficult to treat, and many patients with focal epilepsy continue to have seizures despite multiple medication trials.”
About half of all cases of epilepsy have no known cause and the remainder can be caused by infection, brain injury, strokes, autoimmune disorders, genetics, metabolic issues and more.
This study is randomized, double-blind and placebo-controlled, meaning participants will be randomly assigned to receive either an oral pill containing active drug or a placebo pill (that contains no active drug). Double-blind means that neither the participants nor their doctors know which pill was taken.
“Many people with epilepsy require multiple anti-seizure medications to manage symptoms, and many are also considered drug-resistant to existing medications, meaning they have not responded with complete seizure control after trying multiple medications,” said Melissa Kadar, Director of Advocate Aurora Research Institute’s Center of Excellence in Neuroscience Research. “This is why clinical trials to find new anti-seizure drugs that work differently in the brain are so important.”
Approximately 360 patients worldwide will be enrolled in the study, “A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE2),” which is sponsored by Xenon Pharmaceuticals Inc.
XEN1101 is considered investigational because it is not approved for use in the U.S. outside of a clinical trial.
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