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Sponsors and Collaborators: |
The Methodist Hospital System Christopher Reeve Paralysis Foundation The University of Texas Health Science Center, Houston University of Virginia University of Louisville University of Toronto University of Maryland Thomas Jefferson University University of Miami |
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Information provided by: | The Methodist Hospital System |
ClinicalTrials.gov Identifier: | NCT00876889 |
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 spinal cord injury (SCI).
Condition | Intervention |
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Spinal Cord Injury |
Drug: Riluzole |
Study Type: | Observational |
Study Design: | 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: | May 2009 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | April 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 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 spinal cord injury.
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:
Contact: Elizabeth Toups, MS, RN | 713-441-3897 | etoups@tmhs.org |
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: | Christopher Shields, MD | University of Louisville, Louisville |
Principal Investigator: | Bizhan Aarabi, MD | University of Maryland Medical Center, Baltimore |
Principal Investigator: | James Harrop, MD | Thomas Jefferson University |
Principal Investigator: | James Guest, MD, PhD | University of 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 |
Principal Investigator: | Branko Kopjar, MD, PhD | University of Washington, School of Public Health, Seattle |
Responsible Party: | The Methodist Hospital System ( Robert G. Grossman, MD ) |
Study ID Numbers: | 00002029, W81XWH-07-1-0361 |
Study First Received: | March 25, 2009 |
Last Updated: | April 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00876889 History of Changes |
Health Authority: | United States: Institutional Review Board |
spinal cord injury riluzole pharmacokinetics Acute Traumatic Spinal Cord Injury |
Riluzole Excitatory Amino Acids Spinal Cord Injuries Neurotransmitter Agents Spinal Cord Diseases Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System Neuroprotective Agents Anticonvulsants |
Riluzole Neurotransmitter Agents Spinal Cord Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Excitatory Amino Acid Agents |
Trauma, Nervous System Protective Agents Neuroprotective Agents Pharmacologic Actions Spinal Cord Injuries Therapeutic Uses Central Nervous System Agents Anticonvulsants Excitatory Amino Acid Antagonists |