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Winchester Neurologist & Valley Health Collaborate To Offer New Drug for Children with Treatment-Resistant Epilepsy

The Virginia Comprehensive Epilepsy Program and Valley Health’s Clinical Research Department are conducting a clinical trial using Epidiolex® for two children with catastrophic forms of epilepsy who were not responding to other drugs. Eight weeks after beginning the drug trial in November, the team is optimistic.

Epidiolex is a liquid formulation of pure Cannabidiol (CBD) derived from the cannabis plant. Pioneered by GW Pharmaceuticals, Epidiolex is the first-of-its-kind form of CBD which contains no tetrahydrocannabinol (THC), the major psychoactive ingredient in marijuana. GW Pharmaceuticals, headquartered in the UK, is providing Epidiolex under an “expanded access program” authorized by the Food & Drug Administration (FDA). It is the only company in the world that produces pharmaceutical grade pure plant-derived CBD, which can administered orally as a suspension or via feeding tube.

Initial trials of Epidiolex have shown promising signs of efficacy and safety in children with treatment-resistant epilepsy.

“We are excited to be involved in research that will further determine if these patients will experience a reduction in their seizures and an improved quality of life,” said Paul D. Lyons, MD, PhD, adult and pediatric epileptologist with Winchester Neurological Consultants and principal investigator for the study. “Children with refractory epilepsy face particular challenges as their seizures are extremely difficult or impossible to control. This significantly impacts the child's ability to lead a normal life and is a challenge for the entire family.”

An attending physician at Winchester Medical Center, Dr. Lyons is Medical Director of the Virginia Comprehensive Epilepsy Program, one of the country’s few Level 4 epilepsy programs within a community hospital. The program incorporates neurosurgery, nutrition support and other services.

Beginning in October 2014, another clinical trial began enrolling at a select number of hospital sites to determine the correct dosages for Epidiolex in patients with Dravet syndrome. This syndrome occurs in about one in every 30,000 births. Children with Dravet face a diminished quality of life and may experience dozens or even hundreds of seizures per day. These patients are also prone to prolonged life-threatening seizures called status epilepticus. Seizures in children with Dravet syndrome are often not responsive to currently available medications and are difficult to control. These children often struggle with developmental delays, a variety of health problems and have an increased risk of Sudden Unexplained Death in Epilepsy (SUDEP).

Beginning in the first quarter of 2015, Dr. Lyons and his research team will participate in the next phase of this program, evaluating Epidiolex in treating Dravet syndrome and Lennox Gastaut syndrome (LGS).

The upcoming Epidiolex trials are accepting pediatric and adult patients with confirmed Dravet or LGS syndrome. To learn more, please visit clinical trials.gov or call Jennifer Stanford, RN, MSN, Director, Valley Health Clinical Research Department, at 540-536-8978.

About GW Pharmaceuticals plc
Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 27 countries outside the United States. Sativex is also in Phase 3 clinical development as a potential treatment of pain associated with advanced cancer. GW is also advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex®, which is in Phase 2/3 clinical development for the treatment of Dravet syndrome and which is also expected to enter Phase 3 clinical trials in the treatment of Lennox-Gastaut syndrome. GW has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 clinical development for glioma, ulcerative colitis, type 2 diabetes, and schizophrenia. For further information, please visit www.gwpharm.com.

About Virginia Comprehensive Epilepsy Program
The Virginia Comprehensive Epilepsy Program (VCEP), designated a Level 4 program by the National Association of Epilepsy Centers, is a partnership between Winchester Medical Center, Winchester Neurological Consultants and Virginia Brain & Spine. VCEP provides care for children and adults, with epileptologists Paul Lyons, MD, and J. Craig Henry, MD; neurosurgeon Lee Selznick, MD; ketogenic diet specialist Laila Hammer, RD; and other support services. Winchester Medical Center, a 445-bed regional referral facility, is the largest of the six hospitals of the not-for-profit Valley Health System. Over 350 physicians provide a full range of medical, surgical, diagnostic and rehabilitation services to a tri-state area of more than 400,000 residents. Since 2004 the Valley Health Clinical Research Department has managed more than 100 clinical trials to investigate the efficacy of new drugs and devices before they are approved for use in the U.S. Current trials focus on neurology, cardiology and infectious disease. For more information on epilepsy care, visit www.valleyhealthlink.com/epilepsy.