Riluzole in Spinal Cord Injury Study
Stopped early · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Spinal Cord Injury
In brief
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.
Key facts
- Study ID
- NCT01597518
- Run by
- AOSpine North America Research Network
- People needed
- 193
- Starts
- 2013-10-01
- Expected to finish
- 2020-10-08
- Last updated by the study team
- 2021-04-19
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Barrow Neurological Institute — Phoenix, Arizona, United States
- Santa Clara Valley Medical Center — San Jose, California, United States
- University of Miami — Miami, Florida, United States
- Emory University — Atlanta, Georgia, United States
- Kansas University Medical Center — Kansas City, Kansas, United States
- University of Louisville — Louisville, Kentucky, United States
- Louisiana State University — Baton Rouge, Louisiana, United States
- University of Maryland — Baltimore, Maryland, United States
- Mayo Clinic — Rochester, Minnesota, United States
- University of Missouri — Columbia, Missouri, United States
- Washington University — St Louis, Missouri, United States
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States
- Brooke Army Medical Center — Fort Sam Houston, Texas, United States
- UT Health Center — Houston, Texas, United States
- University of Utah — Salt Lake City, Utah, United States
- University of Virginia — Charlottesville, Virginia, United States
- Swedish Hospital — Seattle, Washington, United States
- University of Wisconsin - Madison — Madison, Wisconsin, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
- John Hunter Hospital — Newcastle, New South Wales, Australia
- Prince of Wales Hospital — Randwick, New South Wales, Australia
- Royal Rehab — Ryde, New South Wales, Australia
- Royal North Shore Hospital — St Leonards, New South Wales, Australia
- Royal Adelaide Hospital — Adelaide, South Australia, Australia
Full record on ClinicalTrials.gov
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