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  • Efficacy and Safety of Riluzole in Acute Spinal Cord Injury (SCI). Rationale and Design of AOSpine Phase III Multi-center Double Blinded Randomized Controlled Trial. (RISCIS)

    Final Number:
    736

    Authors:
    Michael G. Fehlings MD, PhD, FRCS(C), FACS; Branko Kopjar MD; Robert G. Grossman MD

    Study Design:
    Clinical Trial

    Subject Category:

    Meeting: Congress of Neurological Surgeons 2015 Annual Meeting

    Introduction: There is convincing evidence from the preclinical realm that the pharmacologic agent riluzole attenuates certain aspects of the secondary injury cascade leading to diminished neurological tissue destruction in animal SCI models. The safety and pharmacokinetic profile of riluzole have been studied in a multicenter pilot study in 36 patients. Efficacy of riluzole in acute human SCI has not been established.

    Methods: This ongoing multi-center, international double-blinded phase III RCT will enroll 351 patients with acute C4—C8 SCI and ASIA Impairment Grade A, B or C randomized 1:1 to riluzole and placebo. Primary outcome is the change in ASIA Motor Score (AMS) between baseline and 180 days. Other outcmes include ASIA Upper and Lower Extremity MS; ASIA Sensory Score; ASIA grade; SCIM); SF-36v2; EQ-5D and GRASSP. Two-stage sequential adaptive trial statistical design has 90% power to detect 9 points difference in the ASIA Motor Score at one-sided alpha = .025. change in ASIA Motor Score (AMS) between baseline and 180 days. Other outcmes include ASIA Upper and Lower Extremity MS; ASIA Sensory Score; ASIA grade; SCIM); SF-36v2; EQ-5D and GRASSP. Two-stage sequential adaptive trial statistical design has 90% power to detect 9 points difference in the ASIA Motor Score at one-sided alpha = .025.

    Results: A matched cohort analysis performed in the Phase I study showed that riluzole treated cervical SCI patients experienced an additional 15.5 points in AMS recovery at 90 days post injury. Although the phase I study was underpowered to investigate efficacy the current phase II/III study is poised to definitive address this question. Subject enrollment for this trial began on October 1, 2013 in 11 international centers.

    Conclusions: This is a Phase III study of riluzole in acute SCI.

    Patient Care: To determine the efficacy and safety of riluzole in acute human SCI.

    Learning Objectives: To evaluate the efficacy and safety of riluzole in acute human SCI.

    References:

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