LANDOVER, Md., April 24, 2018 (GLOBE NEWSWIRE) -- The Epilepsy Foundation today announced the launch of a new Human Epilepsy Project study of focal seizures to better understand the long-term challenges of living with focal seizures and determine biomarkers of epilepsy severity and treatment response. The biomarkers research study, HEP2, will monitor 200 people with treatment-resistant focal seizures over a two-year period to measure changes in seizure frequency, treatments used, presence of comorbidities — such as depression and anxiety — healthcare costs, and quality of life. HEP2 is the second in a group of registry-based studies called the Human Epilepsy Project, a joint initiative of the Epilepsy Foundation and the Epilepsy Study Consortium to improve the care of people with epilepsy.
“This new research study is another step in our efforts to better understand focal epilepsy and uncover data that will help accelerate therapies to help people with epilepsy have seizure-free lives,” said Dr. Brandy Fureman, Vice President for Research & New Therapies, Epilepsy Foundation. “We believe HEP2 could have a major impact on prevention strategies, treatments and cures for those who have not responded to current treatments.”
Approximately 3.4 million people in the United States have epilepsy, a condition in which a person’s brain has electrical and chemical activity that leads to seizures. Focal epilepsy is the most common type of epilepsy and occurs when a person experiences seizures in one part of their brain. One-third of people with epilepsy live with uncontrollable seizures because no available treatment works for them.
“We currently don’t have biomarkers for epilepsy to help us predict what treatments might work best for a specific patient, or when a patient’s seizures might get better or worse,” said Jacqueline French, M.D., Chief Scientific Officer of the Epilepsy Foundation and Professor of Neurology, NYU Langone Health’s Comprehensive Epilepsy Center. “We hope the HEP2 study will help us uncover possible biomarkers by looking for patterns in the molecules that are shared by people who have similar kinds of seizures, or who have similar responses to medication. The goal is to one day develop targeted treatments with the potential to control seizures faster.”
HEP2 is enrolling participants at designated study centers throughout the U.S., including New York, Connecticut, Pennsylvania, Tennessee, Minnesota, and California. The study will also have an international center in Finland. The HEP2 study will follow 200 participants between the ages of 16 and 65 who have a history of focal epilepsy, have four or more seizures per month and have tried four or more drugs to control seizures without success.
Study participants will be asked to track their seizures, symptoms and medications using My Seizure Diary, a self-management web tool developed by the Epilepsy Foundation specifically for seizures and epilepsy. In addition, participants will need to share their medical records with the research investigators and travel to the clinical site two or three times over the course of the study for health visits and blood samples. A participant may enroll in the HEP2 study but continue to receive their standard epilepsy care with their current physician.
HEP2 is sponsored by the Epilepsy Foundation, with funding provided by UCB, a global pharmaceutical company. Recruitment of eligible study participants is expected to be completed by the end of July 2018. For more information, including eligibility requirements for participating in the study, please visit HEPstudy.org or call 1-800-332-1000.
About the Human Epilepsy Project
The Human Epilepsy Project is an international team of more than 300 doctors, researchers, healthcare workers and patients working together at 27 hospitals to study the biomarkers of new-onset focal epilepsy. The first HEP study was initiated in 2012 as a five-year, prospective, observational study to identify clinical characteristics and biomarkers predictive of disease outcome, progression, and treatment response in participants with new onset or recently diagnosed focal epilepsy. Results of the first HEP study are beginning to be released, including a finding that treatment-resistant focal epilepsy is associated with changes to the brain that resemble premature brain aging (Pardoe et al., 2017).
About the Epilepsy Foundation
The Epilepsy Foundation, a national non-profit with more than 50 local organizations throughout the U.S., has led the fight against seizures since 1968. The Foundation is an unwavering ally for individuals and families impacted by epilepsy and seizures. The mission of the Epilepsy Foundation is: to lead the fight to overcome the challenges of living with epilepsy and to accelerate therapies to stop seizures, find cures, and save lives. The Foundation works to ensure that people with seizures have the opportunity to live their lives to their fullest potential. For additional information, please visit epilepsy.com.
About the Epilepsy Study Consortium
The Epilepsy Study Consortium, a non-profit organization, consists of scientific investigators from academic medical research centers who are dedicated to accelerating the development of new therapies in epilepsy to improve patient care. The organization’s goals include building a partnership between academics, industry and regulatory agencies and optimizing clinical trial methodology. The aim of the consortium is to identify the most effective and safest treatments, and bring them to patients as rapidly as possible.
Pardoe HR, Cole JH, Blackmon K, Thesen T, Kuzniecky R; Human Epilepsy Project Investigators. Structural brain changes in medically refractory focal epilepsy resemble premature brain aging. Epilepsy Res. 2017 Jul;133:28-32.
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