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

Journal of Neurotrauma, 2023 · DOI: 10.1089/neu.2023.0163 · Published: September 1, 2023

Spinal Cord Injury Neurology Research Methodology & Design

Simple Explanation

This study investigated riluzole's effectiveness in patients with acute cervical traumatic spinal cord injury (tSCI). Riluzole is a drug used for ALS that might protect nerve cells after a spinal cord injury. Patients were given either riluzole or a placebo within 12 hours of their injury and monitored for improvements in motor function. The trial was stopped early due to the COVID-19 pandemic. While the main goal of the study wasn't fully met, some secondary analyses suggested that riluzole may offer benefits in functional recovery for certain subgroups of patients with spinal cord injuries.

Study Duration

October 2013 to April 2021

Participants

193 patients with acute cervical tSCI (C4-C8), AIS A-C

Evidence Level

Level III, Randomized, Double-Blinded, Placebo-Controlled Trial

Key Findings

1
The primary analysis did not achieve the predetermined end-point of efﬁcacy for riluzole, likely related to insufﬁcient power.
2
AIS C patients treated with riluzole showed signiﬁcant improvement in total motor scores and upper extremity motor scores at 6 months.
3
AIS B patients had higher reported independence and change in mental health scores at 180 days.

Research Summary

The RISCIS trial evaluated riluzole's safety and efﬁcacy in acute cervical tSCI but was terminated early due to the COVID-19 pandemic. The primary endpoint was not met, but subgroup analyses showed potential benefits in functional recovery for AIS A, B, and C patients. Riluzole demonstrated an excellent safety profile, suggesting it may be a viable option for managing tSCI, an orphan disorder lacking accepted neuroprotective treatment.

Practical Implications

Further Investigation Warranted

The study's secondary outcome analyses suggest the need for further research to validate riluzole's potential benefits in specific SCI subgroups.

Guideline Reassessment

Guideline development groups may consider the clinical relevance of the secondary outcome analyses, particularly given the limited treatment options for SCI.

Trial Design Innovation

The challenges faced highlight the need for innovative trial designs, such as MAMS trials and personalized outcome measures, to address the complexities of SCI research.

Study Limitations

1
Premature termination of the trial due to the COVID-19 pandemic resulted in a smaller sample size.
2
The study cohort was predominately composed of high severity injuries (AIS A) and upper cervical injuries, which tend to have diminished recovery potential.
3
The trial did not reach its recruitment targets, the conclusion of this trial concerning the pre-speciﬁed superiority criteria needs to be interpreted in context.

Your Feedback

Was this summary helpful?

Back to Spinal Cord Injury