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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
AOSpine North America Research Network
Collaborators:
AO Foundation, AO Spine AOSpine International Christopher Reeve Paralysis Foundation Rick Hansen Institute United States Department of Defense