Ortho/neuro-spine clinical trial reaches milestone
AOSpine North America, a non-profit surgeon community aimed at advancing spine care through research and education, announced the enrollment of its 50th subject in the clinical trial titled “A multi-center, randomized, placebo controlled, double-blinded, trial of efficacy and safety of riluzole in acute spinal cord injury”, also known as RISCIS.
The trial is the world’s largest spinal cord injury clinical research effort with more than 20 top-ranked Australian, Canadian and American universities participating. It is funded by awards from the US government, AO Foundation, Christopher and Dana Reeve Foundation, Ontario Neurotrauma Foundation and Rick Hansen Institute. The study is led by Michael G. Fehlings, MD, PhD, Professor and Vice-Chairman of Neurosurgery at the University of Toronto and Robert Grossman, MD, Professor of Neurosurgery, Institute for Academic Medicine at Houston Methodist Hospital. The trial is evaluating the safety and effectiveness of riluzole, an FDA-approved drug for the treatment of amyotrophic lateral sclerosis (ALS), to see if it improves recovery following a spinal cord injury compared to placebo.
The trial builds upon a successful Phase I study that evaluated the safety of the drug in 36 spinal cord injury patients. That early-stage trial showed that the drug is safe and welltolerated in this patient population when administered in an acute setting. For more information about this Phase II/III clinical trial, please visit ClinicalTrials.gov and use the identifier NCT01597518. Or you may contact the study operations team by emailing RISCIS@norconsult.com
