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| Sponsor: | The Methodist Hospital System |
|---|---|
| Collaborators: |
Christopher Reeve Paralysis Foundation Department of Defense AO Clinical Investigation and Documentation Ontario Neurotrauma Foundation |
| Information provided by: | The Methodist Hospital System |
| ClinicalTrials.gov Identifier: | NCT00876889 |
Purpose
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).
| Condition | Intervention |
|---|---|
|
Spinal Cord Injury |
Drug: Riluzole |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Safety and Pharmacokinetics of Riluzole in Patients With Traumatic Acute Spinal Cord Injury |
plasma and cerebral spinal fluid
| Estimated Enrollment: | 36 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | April 2012 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Admitted to a NACTN hospital
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Kentucky | |
| University of Louisville Health Sciences Center | |
| Louisville, Kentucky, United States, 40205 | |
| United States, Maryland | |
| University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Pennsylvania | |
| Thomas Jefferson University | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Texas | |
| The Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| The University of Texas | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| University of Virginia Health System | |
| Charlottesville, Virginia, United States, 22903 | |
| Canada, Ontario | |
| University of Toronto/Toronto Western Hospital | |
| Toronto, Ontario, Canada, M5T-2S8 | |
| Study Chair: | Robert G Grossman, MD | The Methodist Hospital, Houston |
| Principal Investigator: | 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 |
| Principal Investigator: | Diana Chow, PhD | University of Houston, College of Pharmacy, Houston |
More Information
| Responsible Party: | Robert G. Grossman, MD, The Methodist Hospital System |
| ClinicalTrials.gov Identifier: | NCT00876889 History of Changes |
| Other Study ID Numbers: | 00002029, W81XWH-07-1-0361 |
| Study First Received: | March 25, 2009 |
| Last Updated: | June 28, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
spinal cord injury riluzole pharmacokinetics Acute Traumatic Spinal Cord Injury |
|
Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries Riluzole Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Neuroprotective Agents Protective Agents Central Nervous System Agents Therapeutic Uses Anticonvulsants |