Journal
SPINAL CORD
Volume 54, Issue 1, Pages 8-15Publisher
NATURE PUBLISHING GROUP
DOI: 10.1038/sc.2015.95
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Funding
- AOspine North America
- Christopher Reeve Foundation
- Telemedicine and Advanced Technology Research Center (TATRC)
- United States Army Medical Research and Materiel Command (USAMRMC) [W81XWH-13-2-0040 EDMS 3204, W81XWH-10-2-0042]
- Mission Connect (a project of the TIRR Foundation)
- AOSpine International Spinal Cord Injury Knowledge Forum
- Halbert Chair in Neural Repair and Regeneration
- Phillip and Peggy DeZwirek Foundation
- Ontario Neurotrauma Foundation
- Rick Hansen Institute
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Background: Riluzole is a sodium channel-blocking agent used in treating amyotrophic lateral sclerosis. It has been approved by the U.S. Food and Drug Administration, Canadian and Australian authorities, and in many other countries. A phase I trial of riluzole for acute spinal cord injury (SCI) provided safety and pharmacokinetic data and suggested neuroprotective benefits. A phase IIB/III double-blinded randomized controlled trial (RCT) started in January 2014 (https://clinicaltrials.gov, NCT01597518). This article describes the pathophysiological rationale, preclinical experience and design of the phase IIB/III RCT of Riluzole in Acute Spinal Cord Injury Study (RISCIS). Objectives: The primary objective of the trial is to evaluate the superiority of riluzole, at a dose of 100 mg BID in the first 24 h followed by 50 mg BID for the following 13 days post injury, compared with placebo in improving neurological motor outcomes in patients with C4-C8 level, International Standards for Neurological Classification of Spinal Cord Injury Examination (ISNCSCI) grade A, B or C acute (within 12 h post injury) SCI. Setting: Acute trauma centers worldwide Methods: A double-blind, multi-center, placebo-controlled RCT will enroll 351 participants randomized 1: 1 to riluzole and placebo. The primary end point is the change between 180 days and baseline in ISNCSCI Motor Score. This study has 90% power to detect a change of nine points in ISNCSCI Motor Score at one-sided alpha=0.025. Results: Currently enrolling in 11 centers. Conclusion: This study will provide class I evidence regarding the safety and neuroprotective efficacy of riluzole in patients with acute cervical SCI.
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