Riluzole in Spinal Cord Injury Study
Public ClinicalTrials.gov record NCT01597518. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-Center, Randomized, Placebo Controlled, Double-Blinded, Trial of Efficacy and Safety of Riluzole in Acute Spinal Cord Injury
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01597518
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 193 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2013 (Actual)
- Primary completion
- Oct 8, 2020 (Actual)
- Completion
- Oct 8, 2020 (Actual)
- Last update posted
- Apr 19, 2021
2013 – 2020
United States locations
- U.S. sites
- 20
- U.S. states
- 16
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | — |
| Santa Clara Valley Medical Center | San Jose | California | 95128 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Emory University | Atlanta | Georgia | 30303 | — |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Louisiana State University | Baton Rouge | Louisiana | 70803 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| University of Missouri | Columbia | Missouri | 65212 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | — |
| UT Health Center | Houston | Texas | 77030 | — |
| University of Utah | Salt Lake City | Utah | 84112 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
| Swedish Hospital | Seattle | Washington | 98122 | — |
| University of Wisconsin - Madison | Madison | Wisconsin | 53706 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01597518, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 19, 2021 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01597518 live on ClinicalTrials.gov.