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Spinal Cord. 2016 Jan;54(1):8-15. doi: 10.1038/sc.2015.95. Epub 2015 Jun 23.

Rationale, design and critical end points for the Riluzole in Acute Spinal Cord Injury Study (RISCIS): a randomized, double-blinded, placebo-controlled parallel multi-center trial.

Author information

1
Division of Neurosurgery and Spinal Program, Department of Surgery, University of Toronto, Toronto Western Hospital, Toronto, Ontario, Canada.
2
Department of Orthopedic Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
3
Department of Orthopaedic Surgery, Keio University School of Medicine, Tokyo, Japan.
4
Department of Pharmacological and Pharmaceutical Sciences, University of Houston, Houston, TX, USA.
5
Department of Neurosurgery, Houston Methodist Hospital,Houston,TX,USA.
6
Department of Health Services, University of Washington, Seattle, WA, USA.

Abstract

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 worldwideMethods: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 α=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.

PMID:
26099215
PMCID:
PMC5399137
DOI:
10.1038/sc.2015.95
[Indexed for MEDLINE]
Free PMC Article

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