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Contrast Enhanced Ultrasound Imaging for Assessment of Spinal Cord Blood Flow in Experimental Spinal Cord Injury
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Safety and Efficacy of Riluzole in Acute Spinal Cord Injury Study (RISCIS): A Multi-Center, Randomized,

Michael G Fehlings1,2, Ali Moghaddamjou1, James S Harrop3

  • 1Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.

Journal of Neurotrauma
|June 6, 2023
PubMed
Summary

Riluzole did not meet its primary endpoint for treating acute cervical traumatic spinal cord injury (tSCI). However, secondary analyses indicated functional recovery benefits across all American Spinal Injury Association Impairment Scale (AIS) grades A-C.

Keywords:
clinical trialglutamate antagonistneuroprotectionneurotraumasodium channel blockerspinal cord injury

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Area of Science:

  • Neuroscience
  • Clinical Trials
  • Spinal Cord Injury Research

Background:

  • Riluzole, a sodium-glutamate antagonist, shows promise in neurodegenerative conditions like ALS and pre-clinical models of spinal cord injury.
  • Early clinical trials suggest potential benefits for traumatic spinal cord injury (tSCI).

Purpose of the Study:

  • To evaluate the efficacy and safety of riluzole in patients with acute cervical tSCI.
  • To assess riluzole's impact on motor function recovery in a Phase III clinical trial setting.

Main Methods:

  • A multi-center, randomized, double-blinded, placebo-controlled Phase III trial (NCT01597518) involving 193 patients with acute cervical tSCI (AIS A-C).
  • Patients received either riluzole or placebo, with the primary endpoint being the change in Upper Extremity Motor (UEM) scores at 180 days.
  • The trial was adaptive and halted early due to the COVID-19 pandemic, with enrollment at 54.9% of the planned 351 patients.

Main Results:

  • The primary efficacy analysis did not reach statistical significance, likely due to insufficient sample size.
  • Secondary analyses revealed significant improvements in total motor scores and UEM scores at 180 days for the AIS C subgroup.
  • AIS B patients showed improved independence and mental health, while AIS A patients demonstrated a higher average gain in neurological levels with riluzole treatment.

Conclusions:

  • While the primary endpoint was not met, riluzole demonstrated potential functional recovery benefits in secondary analyses across all cervical tSCI subgroups (AIS A-C).
  • The findings suggest that riluzole may warrant further investigation for treating acute cervical tSCI, particularly considering the lack of established neuroprotective treatments.
  • Guideline development groups may consider the clinical relevance of these secondary outcome analyses for this rare orphan disorder.