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

Spinal Cord

Volumn 54, Issue 1, 2016, Pages 8-15

  Fehlings, M G ^a   Nakashima, H ^a,b   Nagoshi, N ^a,c   Chow, D S L ^d   Grossman, R G ^e   Kopjar, B ^f  

^a UNIVERSITY OF TORONTO   (Canada)

^b NAGOYA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^c KEIO UNIVERSITY   (Japan)

^d UNIVERSITY OF HOUSTON   (United States)

^e HOUSTON METHODIST HOSPITAL   (United States)

^f UNIVERSITY OF WASHINGTON   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; RILUZOLE; NEUROPROTECTIVE AGENT;

ACUTE DISEASE; ADULT; AGED; ARTICLE; ASSESSMENT OF HUMANS; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; EMERGENCY HEALTH SERVICE; FEMALE; HUMAN; INTERNATIONAL STANDARD FOR NEUROLOGICAL CLASSIFICATION OF SPINAL CORD INJURY EXAMINATION SCORE; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MOTOR ACTIVITY; MULTICENTER STUDY; PARALLEL DESIGN; PATHOPHYSIOLOGY; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SPINAL CORD INJURY; TREATMENT OUTCOME; ADOLESCENT; CLINICAL TRIAL; FOLLOW UP; MIDDLE AGED; SEVERITY OF ILLNESS INDEX; SPINAL CORD INJURIES; TIME FACTOR; YOUNG ADULT;

ACUTE DISEASE; ADOLESCENT; ADULT; AGED; DOUBLE-BLIND METHOD; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; NEUROPROTECTIVE AGENTS; RILUZOLE; SEVERITY OF ILLNESS INDEX; SPINAL CORD INJURIES; TIME FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84983171493     PISSN: 13624393     EISSN: 14765624     Source Type: Journal    
DOI: 10.1038/sc.2015.95     Document Type: Article

References (20)

1. Sekhon LH, Fehlings MG. Epidemiology, demographics, and pathophysiology of acute spinal cord injury. Spine 2001; 26: S2-S12.
2. Baptiste DC, Fehlings MG. Pharmacological approaches to repair the injured spinal cord. J Neurotrauma 2006; 23: 318-334.
3. Miller RG, Mitchell J, Moore DH. Riluzole for amyotrophic lateral sclerosis (ALS)/motor neuron disease (MND). Cochrane Database Syst Rev 2012; 3: CD001447.
4. Schwartz G, Fehlings MG. Evaluation of the neuroprotective effects of sodium channel blockers after spinal cord injury: improved behavioral and neuroanatomical recovery with riluzole. J Neurosurg 2001; 94: 245-256.
5. Wu Y, Satkunendrarajah K, Teng Y, DS-L Chow, Buttigieg J, Fehlings MG. Delayed postinjury administration of riluzole is neuroprotective in a preclinical rodent model of cervical spinal cord injury. J Neurotrauma 2013; 30: 441-452.
6. Grossman RG, Fehlings MG, Frankowski RF, Burau KD, Chow DS, Tator C et al. A prospective, multicenter, phase I matched-comparison group trial of safety, pharmacokinetics, and preliminary efficacy of riluzole in patients with traumatic spinal cord injury. J Neurotrauma 2014; 31: 239-255.
7. Tator CH, Fehlings MG. Review of the secondary injury theory of acute spinal cord trauma with emphasis on vascular mechanisms. J Neurosurg 1991; 75: 15-26.
8. Bracken MB. Steroids for acute spinal cord injury. Cochrane Database Syst Rev 2012; 1: Cd001046.
9. Geisler FH, Coleman WP, Grieco G, Poonian D. Sygen Study Group The Sygen® multicenter acute spinal cord injury study. Spine 2001; 26: S87-S98.
10. Fehlings MG, Vaccaro A, Wilson JR, Singh A, Cadotte DW, Harrop JS et al. Early versus delayed decompression for traumatic cervical spinal cord injury: results of the Surgical Timing in Acute Spinal Cord Injury Study (STASCIS). PLoS one 2012; 7: e32037.
11. Agrawal SK, Fehlings MG. Mechanisms of secondary injury to spinal cord axons in vitro: role of Na+, Na(+)-K(+)-ATPase, the Na(+)-H+ exchanger, and the Na(+)-Ca2+exchanger. J Neurosci 1996; 16: 545-552.
12. Tietze KJ, Putcha L. Factors affecting drug bioavailability in space. J Clin Pharmacol 1994; 34: 671-676.
13. Stys PK. General mechanisms of axonal damage and its prevention. J Neurol Sci 2005; 233: 3-13.
14. Fehlings MG, Wilson JR, Karadimas SK, Arnold PM, Kopjar B. Clinical evaluation of a neuroprotective drug in patients with cervical spondylotic myelopathy undergoing surgical treatment: design and rationale for the CSM-protect trial. Spine 2013; 38: S68-S75.
15. Kretschmer BD, Kratzer U, Schmidt WJ. Riluzole a glutamate release inhibitor, and motor behavior. Naunyn Schmiedebergs Arch Pharmacol 1998; 358: 181-190.
16. Fumagalli E, Funicello M, Rauen T, Gobbi M, Mennini T. Riluzole enhances the activity of glutamate transporters GLAST, GLT1 and EAAC1. Eur J Pharmacol 2008; 578: 171-176.
17. Chow DS, Teng Y, Toups EG, Aarabi B, Harrop JS, Shaffrey CI et al. Pharmacology of riluzole in acute spinal cord injury. J Neurosurg 2012; 17: 129-140.
18. Kirshblum SC, Burns SP, Biering-Sorensen F, Donovan W, Graves DE, Jha A et al. International standards for neurological classification of spinal cord injury (revised 2011). J Spinal Cord Med 2011; 34: 535-546.
19. Catz A. Spinal Cord Independence Measure. In: Kreutzer JS, DeLuca J, Caplan B (eds) Encyclopedia of Clinical Neuropsychology. Springer: New York, NY, 2011, pp 2351-2353.
20. Kalsi-Ryan S, Curt A, Verrier MC, Fehlings MG. Development of the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP): reviewing measurement specific to the upper limb in tetraplegia. J Neurosurg 2012; 17: 65-76.