The Autoimmune Encephalitis Alliance and Option Care Enterprises, Inc. are co-sponsoring a clinical trial at Mayo Clinic to evaluate intravenous immunoglobulin (IVIG) treatment in patients with autoimmune epilepsy who fail to benefit from standard epilepsy medications.
This study, the first of its kind, builds on Mayo Clinic research advances identifying new approaches to the diagnosis and treatment of autoimmune epilepsy.1 Despite the introduction of many new antiseizure drugs in the last few decades, approximately one-third of patients with epilepsy have seizures that do not respond to antiepileptic drugs.2 Many of them are suspected to have autoimmune epilepsy, one type of autoimmune encephalitis. For these patients, the implications of a potential alternate treatment approach are significant.
Autoimmune encephalitis, a severe inflammation of the brain, is an increasingly recognized condition in which the immune system attacks the brain, impairing function. It can cause a wide range of symptoms, including epileptic seizures. While preliminary research suggests IVIG may be beneficial for those with suspected autoimmune epilepsy, this will be the first randomized, double-blind, placebo-controlled trial to rigorously assess whether five weeks of treatment can reduce or stop seizures and improve cognitive performance in these patients. The study also will follow patients for a period of one year following IVIG therapy to evaluate post-treatment response.
AEA provided money for patient travel and committed to recruiting patients. The trial will include a total of 30 patients and the first patients have been enrolled. Option Care, a leading national provider of home and alternate treatment site infusion services, is donating its clinical home infusion services and nursing care for patients participating in the trial.
“We’re honored to support the first randomized controlled trial for a promising therapy for patients who have limited options, and we are equally pleased to work with the Autoimmune Encephalitis Alliance, the leading U.S.-based patient advocacy organization working on behalf of this group of patients and their families,” said Gretchen Ayer, Director of Business Development for the Option Care IG program.
“The life-altering and sometimes tragic consequences faced by patients with autoimmune encephalitis compel the AE Alliance to find an alternate treatment for this disease. The AE Alliance is proud to work with Mayo Clinic and Option Care by providing critical funding to support this important study,” said John Spencer, executive director of the AE Alliance. “This is a critical research step toward scientific assessment of a therapy that early studies suggest holds real promise for patients with AE.”
Sean J. Pittock, M.D., a neurologist at Mayo Clinic, is one of the co-authors of ground-breaking 2014 research on autoimmune epilepsy and will serve as the principal investigator for the trial. Dr. Pittock is the director of Mayo Clinic’s Center for Multiple Sclerosis and Autoimmune Neurology and the director of the Neuroimmunology Laboratory at Mayo Clinic.
About Option Care
Option Care Enterprises, Inc. (Option Care) is one of the nation’s largest and most trusted providers of home and alternate treatment site infusion services. An industry leader, the company draws on nearly 40 years of clinical care experience to offer patient-centered therapy management. Option Care’s signature Home Infusion Plus services include the clinical management of infusion medicines, nursing support and care coordination. Option Care’s multidisciplinary team of more than 1,800 clinicians – including pharmacists, nurses and dietitians – are able to provide home infusion service coverage for nearly all patients across the United States needing treatment for complex and chronic conditions. Learn more at www.OptionCare.com.
About the Autoimmune Encephalitis Alliance
The Autoimmune Encephalitis Alliance (AEA) improves the lives of patients with autoimmune encephalitis by promoting collaboration in clinical and basic research and by creating a community of patients, families, and caregivers so that no one faces autoimmune encephalitis alone.
The AE Alliance strives to find a cure for autoimmune encephalitis through multi-disciplinary, collaborative research, and clinical care. The AE Alliance is a 501(c)(3) non-profit and all services are free of charge. For more information visit www.aealliance.org.
1 Toledano M, et al. Utility of an immunotherapy trial in evaluating patients with presumed autoimmune epilepsy. Neurology. 2014;82:1578.
2 Ruegg S and Panzer, JA. Immune therapy for pharmacoresistant epilepsy. Neurology. 2014. 82:1572-1573.