Riluzole in Spinal Cord Injury Study

24-Nov-2015

Name:
Dr Ralph Stanford (Lead Principal Investigator in Australia)

Organisation:
Prince of Wales Hospital, Royal North Shore Hospital, Royal Adelaide Hospital

Location:
United States, Canada and Australia (various locations)

Address:

Email:

ACTRN:
NCT01597518

Sponsor Name:

Start Date:

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

Description:
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.

Click here to view the trial at ANZCTR website.
Click here to view the trial at the Clinical Trials Gov website.




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