Spinal Cord Injury Clinical Trial
Official title:
Phase III Randomized, Double-Blind Study of Methylprednisolone by 24- Versus 48-Hour Infusion Versus Tirilazad for Acute Spinal Cord Injury
Verified date | September 2008 |
Source | Office of Rare Diseases (ORD) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
OBJECTIVES:
I. Compare the efficacy and safety of 24- versus 48-hour infusion of methylprednisolone
(MePRDL) versus tirilazad for patients with acute spinal cord injury.
II. Compare neurologic recovery following 24- and 48-hour MePRDL infusions.
Status | Completed |
Enrollment | 497 |
Est. completion date | |
Est. primary completion date | August 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 14 Years and older |
Eligibility |
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Acute spinal cord injury; diagnosis confirmed by study physician using National Acute Spinal Cord Injury Study neurologic exam Glasgow Coma Score greater than 9 Randomization within 6 hours of injury required; treatment must begin within 8 hours of injury No root involvement only; no cauda equina only --Prior/Concurrent Therapy-- Methylprednisolone bolus (20-40 mg/kg) prior to hospital admission allowed --Patient Characteristics-- Hematopoietic: No hematologic contraindication to protocol therapy Cardiovascular: No vascular contraindication to protocol therapy Other: No diabetes; No gunshot wound; No gastrointestinal bleeding; No life-threatening co-morbidity; No other medical contraindication to protocol therapy; No pregnant women; No patients under indictment or incarcerated; No conditions that would complicate follow-up, e.g.: out-of-state residency or illegal alien status |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Institute of Neurological Disorders and Stroke (NINDS) | Yale University |
Bracken MB, Shepard MJ, Holford TR, Leo-Summers L, Aldrich EF, Fazl M, Fehlings M, Herr DL, Hitchon PW, Marshall LF, Nockels RP, Pascale V, Perot PL Jr, Piepmeier J, Sonntag VK, Wagner F, Wilberger JE, Winn HR, Young W. Administration of methylprednisolone for 24 or 48 hours or tirilazad mesylate for 48 hours in the treatment of acute spinal cord injury. Results of the Third National Acute Spinal Cord Injury Randomized Controlled Trial. National Acute Spinal Cord Injury Study. JAMA. 1997 May 28;277(20):1597-604. — View Citation
Bracken MB, Shepard MJ, Holford TR, Leo-Summers L, Aldrich EF, Fazl M, Fehlings MG, Herr DL, Hitchon PW, Marshall LF, Nockels RP, Pascale V, Perot PL Jr, Piepmeier J, Sonntag VK, Wagner F, Wilberger JE, Winn HR, Young W. Methylprednisolone or tirilazad mesylate administration after acute spinal cord injury: 1-year follow up. Results of the third National Acute Spinal Cord Injury randomized controlled trial. J Neurosurg. 1998 Nov;89(5):699-706. — View Citation
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