- April 25, 2018
- Posted by: PharmaScroll
- Category:
The Epilepsy Foundation 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 at 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.
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News Source: Epilepsy Foundation
Image source: http://thechurchinmalta.org/en/posts/75506/epilepsy-more-than-just-seizures