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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-07-0042 | Other Identifier | Department of Defense |
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| Name | Class |
|---|---|
| Christopher Reeve Paralysis Foundation | OTHER |
| United States Department of Defense | FED |
| AO Clinical Investigation and Publishing Documentation | OTHER |
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The purpose of the study is to find out if the use of the drug Riluzole is both safe and improves outcome in patients with acute traumatic spinal cord injury (SCI).
The primary aim of the study is to develop acute care safety and pharmacokinetic profiles of riluzole in patients who have sustained a acute traumatic spinal cord injury. Secondary objectives are to conduct exploratory analyses of functional outcomes for purposes of planning a subsequent Phase II randomized study of the efficiency of Riluzole for the treatment of acute traumatic spinal cord injury.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riluzole | Drug | 50mg PO (by mouth) every 12 hours starting within 12 hours of injury and continuing for 14 days (28 doses). |
|
| Measure | Description | Time Frame |
|---|---|---|
| American Spinal Injury Association Impairment Scale | Neurological assessment and classification of spinal cord injury | Baseline, days 3 and 14, 6 weeks, 3 and 6 months and unscheduled follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Admitted to a NACTN hospital
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| Name | Affiliation | Role |
|---|---|---|
| Robert G Grossman, MD | The Methodist Hospital Research Institute | Study Chair |
| Michael Fehlings, MD, PhD | University of Toronto/Toronto Western Hospital, Toronto | Principal Investigator |
| Michele M Johnson, MD | the University of Houston/Memorial HermannHospital, Houston | Principal Investigator |
| Christopher Shaffery, MD | University of Virginia Health System, Charlottesville | Principal Investigator |
| Susan Harkema, PhD | University of Louisville, Louisville | Principal Investigator |
| Bizhan Aarabi, MD | University of Maryland Medical Center, Baltimore | Principal Investigator |
| James Harrop, MD | Thomas Jefferson University, Philadelphia | Principal Investigator |
| James Guest, MD, PhD | University of Miami, Miami | Principal Investigator |
| Ralph Frankowski, PhD | The University of Texas School of Public Health, Houston |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States | ||
| University of Louisville Health Sciences Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39446982 | Derived | Carroll AH, Fakhre E, Quinonez A, Tannous O, Mesfin A. An Update on Spinal Cord Injury and Current Management. JBJS Rev. 2024 Oct 24;12(10). doi: 10.2106/JBJS.RVW.24.00124. eCollection 2024 Oct 1. | |
| 37130044 | Derived | Chow DS, Nguyen A, Park J, Wu L, Toups EG, Harrop JS, Guest JD, Schmitt KM, Aarabi B, Fehlings MG, Boakye M, Grossman RG. Riluzole in Spinal Cord Injury Study (RISCIS)-Pharmacokinetic (PK) Sub-Study: An Analysis of Pharmacokinetics, Pharmacodynamics, and Impact on Axonal Degradation of Riluzole in Patients With Traumatic Cervical Spinal Cord Injury Enrolled in the RISCIS Phase III Randomized Controlled Trial. J Neurotrauma. 2023 Sep;40(17-18):1889-1906. doi: 10.1089/neu.2022.0499. |
| Label | URL |
|---|---|
| The Reeve Foundation is dedicated to curing spinal cord injury by funding innovative research, and improving the quality of life for people living with paralysis through grants, information and advocacy. Click here for more information about the network. | View source |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D019782 | Riluzole |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D052160 | Benzothiazoles |
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| Ontario Neurotrauma Foundation |
| OTHER |
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plasma and cerebral spinal fluid
| Principal Investigator |
| Diana Chow, PhD | University of Houston, College of Pharmacy, Houston | Principal Investigator |
| Louisville |
| Kentucky |
| 40205 |
| United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| The University of Texas | Houston | Texas | 77030 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22903 | United States |
| University of Toronto/Toronto Western Hospital | Toronto | Ontario | M5T-2S8 | Canada |
| 25939067 | Derived | Nagoshi N, Nakashima H, Fehlings MG. Riluzole as a neuroprotective drug for spinal cord injury: from bench to bedside. Molecules. 2015 Apr 29;20(5):7775-89. doi: 10.3390/molecules20057775. |
| 22985381 | Derived | Fehlings MG, Wilson JR, Frankowski RF, Toups EG, Aarabi B, Harrop JS, Shaffrey CI, Harkema SJ, Guest JD, Tator CH, Burau KD, Johnson MW, Grossman RG. Riluzole for the treatment of acute traumatic spinal cord injury: rationale for and design of the NACTN Phase I clinical trial. J Neurosurg Spine. 2012 Sep;17(1 Suppl):151-6. doi: 10.3171/2012.4.AOSPINE1259. |
| 22985379 | Derived | Chow DS, Teng Y, Toups EG, Aarabi B, Harrop JS, Shaffrey CI, Johnson MM, Boakye M, Frankowski RF, Fehlings MG, Grossman RG. Pharmacology of riluzole in acute spinal cord injury. J Neurosurg Spine. 2012 Sep;17(1 Suppl):129-40. doi: 10.3171/2012.5.AOSPINE12112. |
| D014947 | Wounds and Injuries |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |