Riluzole in Acute Spinal Cord Injury study—RISCIS reaches significant milestone with 100 patients enrolled

23. November 2017

A major clinical trial by AOSpine Knowledge Forum Spinal Cord (KFSCI) has just surpassed its 100-mark of patients enrolled. "This is a significant milestone", principal investigator (PI) Dr. Michael Fehlings congratulates Drs. Christopher Shaffrey, Karl Schmitt and James D. Guest, whose latest patient enrollments brought the total up to 102 patients.

KFSCI Steering Committee meeting in Milan, Italy, 2017 setting new milestones also for the RISCIS trial. Back row: Jeff Wilson (associate member), Vafa Rahimi-Movaghar (AOSpine Research Commission member, Middle East), Mark Kotter, Shekar Kurpad, James Harrop, Brian Kwon. Front row: Bizhan Aarabi, Knowledge Forum Manager María Alvarez Sánchez, Chairperson Michael Fehlings and KF Trauma Chairperson Cumhur Öner.

​Dr. Fehlings expects the multi-center, randomized, placebo controlled, double-blinded trial on the efficacy and safety of the drug Riluzole to reach its final enrollment target in five years. Fehlings trusts the study will ultimately lead to improved outcomes for patients with spinal cord injury (SCI), with an effective therapeutic treatment to complement surgery.

SCI results in devastating physical impairment and is associated with significant costs to the individual and to society. "The trial shows considerable promise to enhance the neurological outcomes and quality of life and reduce the costs of care for individuals with acute SCI”, Fehlings summarizes. Riluzole is a sodium-glutamate antagonist, approved as treatment to attenuate the rate of nerve cell degeneration in Amyotrophic Lateral Sclerosis (ALS). KFSCI was convinced by the promise Riluzole had shown earlier in preclinical models of traumatic and non-traumatic SCI. Since the initiation of the RISCIS trial in 2013, the study has grown to include 22 sites across the United States, Canada and southeastern Australia, and clinician-scientists from Europe, Asia and the Middle East have expressed their interest in joining this collaborative international research effort.

The willingness of the participating sites and principal investigators to contribute their time and funds has made this a study with more than 25 sponsoring organizations possible. Many of the sites have initiated SCI sub-studies, including efforts to research MRI biomarkers in SCI, the pharmacokinetic properties of the study drug and quality assurance comparisons for patients presenting with SCI to two separate hospitals in the same health system.

The RISCIS trial is supported by AOSpine International, AOSpine North America, Christopher and Dana Reeve Foundation’s North American Clinical Trial Network (NACTN), Ontario Neurotrauma Foundation, U.S. Department of Defense and Rick Hansen Institute. AOSpine and the collaborating partners would like to take this opportunity to thank all the investigators, study coordinators and AO members for their continued efforts in promoting world-class research through their participation in the RISCIS trial.

For more information about the Knowledge Forum SCI see http://www.aospine.org/kf-sci.

More information about the trial can be found on https://clinicaltrials.gov/ct2/show/NCT01597518, or please email RISCIS@nor-consult.com.



Images

Icon RISCIS core group making plans to launch the study in Houston, TX, USA 2012.