Evidence map›Paper›PMID 26099215›Full record

Trial reportSpinal cord2016

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.

M G Fehlings, H Nakashima, N Nagoshi, D S L Chow, R G Grossman, B Kopjar

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Spinal cord, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01597518 (A Multi-Center, Randomized, Placebo Controlled, Double-Blinded, Trial of Efficacy and Safety of Riluzole in Acute Spinal Cord Injury), which is not on this map. Cited by 62 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 1 pooled it
8.2field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01597518 phase2 / phase3terminatednot on this map

A Multi-Center, Randomized, Placebo Controlled, Double-Blinded, Trial of Efficacy and Safety of Riluzole in Acute Spinal Cord Injury

TypeinterventionalSponsorAOSpine North America Research NetworkRan2013 to 2020Enrolled193ConditionsSpinal Cord InjuryArmsRiluzole, Placebo
3 · Its place in the literature

Who cites it

62 citing papers in PubMed, 1 synthesis or guideline pooled it, 135 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Review
  8. Article
  9. Review
  10. Review
  11. Exploring the Landscape of Biomarkers in Spinal Cord Injury.Topics in spinal cord injury rehabilitation · 2025
    Review
  12. Review
  13. Article
  14. Review
  15. Review
  16. Article
  17. Neuroplasticity and regeneration after spinal cord injury.North American Spine Society journal · 2023
    Article
  18. Article
  19. Edema after CNS Trauma: A Focus on Spinal Cord Injury.International journal of molecular sciences · 2023
    Review
  20. Review

2 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 3 countries.

M G FehlingsDivision of Neurosurgery and Spinal Program, Department of Surgery, University of Toronto, Toronto Western Hospital, Toronto, Ontario, Canada.
H NakashimaDivision of Neurosurgery and Spinal Program, Department of Surgery, University of Toronto, Toronto Western Hospital, Toronto, Ontario, Canada.
N NagoshiDivision of Neurosurgery and Spinal Program, Department of Surgery, University of Toronto, Toronto Western Hospital, Toronto, Ontario, Canada.
D S L ChowDepartment of Pharmacological and Pharmaceutical Sciences, University of Houston, Houston, TX, USA.
R G GrossmanDepartment of Neurosurgery, Houston Methodist Hospital,Houston,TX,USA.
B KopjarDepartment of Health Services, University of Washington, Seattle, WA, USA.
Toronto Western Hospital · CAKeio University · JPUniversity of Houston · USUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRiluzole 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).

objectivesThe 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.

settingAcute 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.

resultsCurrently enrolling in 11 centers.

conclusionThis study will provide class I evidence regarding the safety and neuroprotective efficacy of riluzole in patients with acute cervical SCI.

Indexed as

Acute DiseaseAdolescentAdultAgedDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedNeuroprotective AgentsRiluzoleSeverity of Illness IndexSpinal Cord InjuriesTime FactorsTreatment OutcomeNeuroprotective AgentsRiluzole

Identifiers

PMID26099215
PMCPMC5399137
OpenAlexW836150979

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.