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Riluzole in Spinal Cord Injury Study

NCT01597518 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2021-04-19

No results posted yet for this study

Summary

The aim of this study is to evaluate efficacy and safety of riluzole in the treatment of patients with acute SCI. The primary objective is to evaluate the superiority of riluzole, at a dose of 2 x 100 mg the first 24 hours followed by 2 x 50 mg for the following 13 days after injury, as compared to placebo, in change between 180 days and baseline in motor outcomes as measured by International Standards for Neurological Classification of Spinal Cord Injury Examination (ISNCSCI) Motor Score, in patients with acute traumatic SCI, presenting to the hospital less than 12 hours after injury. Secondary objectives are to evaluate the effects of riluzole on overall neurologic recovery, sensory recovery, functional outcomes, quality of life outcomes, health utilities, mortality, and adverse events. The working hypothesis is that the riluzole treated subjects will experience superior motor, sensory, functional, and quality of life outcomes as compared to those receiving placebo, with an acceptable safety profile.

Conditions

  • Spinal Cord Injury

Interventions

DRUG

Riluzole

100mg BID first 24 hours after the injury; 50mg BID 2--14 days following the injury

DRUG

Placebo

Placebo 2x in first 24 hours; Placebo 2x day 2--14

Sponsors & Collaborators

  • AO Foundation, AO Spine

    collaborator OTHER

  • United States Department of Defense

    collaborator FED

  • Rick Hansen Institute

    collaborator OTHER

  • Christopher Reeve Paralysis Foundation

    collaborator OTHER

  • AOSpine North America Research Network

    lead NETWORK

Principal Investigators

  • Michael Fehlings, MD, PhD · University Health Network, Toronto, Canada

  • Branko Kopjar, MD, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2020-10-08
Completion
2020-10-08

Countries

  • United States
  • Australia
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01597518 on ClinicalTrials.gov