Tilray, Canada's leading licensed producer of high quality medical cannabis, today announced its support for a clinical trial at The Hospital for Sick Children in Toronto (SickKids) to evaluate the safety and tolerability of a combination cannabinoid preparation as an adjunct treatment for refractory (treatment-resistant) epilepsy in children.
The Phase II trial, designed by researchers at SickKids will examine a combination cannabinoid therapy for children with Dravet Syndrome, a rare and debilitating form of epilepsy that begins in infancy and is characterized by frequent seizures, poor seizure control, and developmental delays. It will be conducted by Dr. Bláthnaid McCoy and her team in the Division of Neurology at SickKids.
The study will involve 20 participants and is the first-ever clinical trial of its kind using a plant extract containing a concise preparation of cannabinoids in an oral liquid formulation. The objectives of the study are to identify and document a safe starting dose and titration schedule, and to uncover any potential side effects, drug interactions, adverse events, and change in EEG patterns (electrical activity of the brain).
Tilray is proud to support this important safety and tolerability study, with the desired outcome of arming physicians and parents with significant dosing and tolerability data on a combination cannabinoid product for treatment of seizures in a pediatric population, and expanding the research knowledge base to inform future efficacy trials with formulations containing multiple cannabinoids.
"We need to understand the safety of this novel formulation in order to proceed with larger clinical trials which will continue to advance the scientific research and understanding of the efficacy of cannabinoid treatment for disease management," explains Dr. Catherine Jacobson, Director of Clinical Research at Tilray. "If it is found that a certain CBD/THC combination is well-tolerated and safe, and we can begin to understand dosing parameters, further research can be conducted to examine the efficacy of this combination drug in treating seizures to help physicians and families manage their child's condition properly and safely."
This trial is a critical step to uncovering an effective way to alleviate the seizure burden in this population of children with a rare, difficult-to-treat disease. Each day in Canada, an average of 42 people learn that they have epilepsy, with approximately 15,500 people diagnosed annually; 44% are diagnosed before the age of 5, 55% before the age of 10, 75-85% before age 18 and 1% of children will have recurrent seizures before age 14.
This first-of-its-kind pediatric epilepsy clinical trial is one of several research efforts underway at Tilray, a global leader in medical cannabis research, production and cultivation. Earlier this year, Tilray announced two additional ground-breaking clinical research collaborations: Canada's first clinical trial to evaluate the therapeutic potential of medical cannabis as treatment for symptoms associated with post-traumatic stress disorder (PTSD) in partnership with the University of British Columbia, as well as a partnership in Australia with the New South Wales (NSW) Government, the University of Sydney and Chris O`Brien Lifehouse to develop a novel medical cannabis treatment for chemotherapy-induced nausea and vomiting (CINV). In the coming months, the company is poised to announce additional scientific trials to continue examining the efficacy of medical cannabis treatment for a subset of medical conditions and diseases.
The SickKids trial is expected to start in early 2017.
Tilray is a global leader in medical cannabis research and production dedicated to advancing the science, efficacy and safety of cannabinoid medicine for patients with a diverse range of conditions. The company operates one of the largest and most sophisticated federally licensed medical cannabis cultivation facilities in the world, offering a range of products to patients, pharmacies and researchers in Canada, Australia, the European Union and the Americas.