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| Sponsors and Collaborators: |
National Institute of Neurological Disorders and Stroke (NINDS) Yale University |
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004759 |
Purpose
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.
| Condition | Intervention | Phase |
|
Spinal Cord Injury |
Drug: methylprednisolone Drug: tirilazad |
Phase III |
| MedlinePlus related topics: | Spinal Cord Injuries |
| Drug Information available for: | Methylprednisolone Tirilazad Tirilazad mesylate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase III Randomized, Double-Blind Study of Methylprednisolone by 24- Versus 48-Hour Infusion Versus Tirilazad for Acute Spinal Cord Injury |
| Estimated Enrollment: | 497 |
| Study Start Date: | December 1991 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
PROTOCOL OUTLINE:
This is a randomized, double-blind study. Patients are stratified by participating institution.
Patients are randomly assigned to 1 of 3 treatment groups within 6 hours of injury. Treatment begins within 2 hours of randomization.
One group receives a 24-hour methylprednisolone (MePRDL) infusion: a loading dose followed in 45 minutes by a 23-hour continuous infusion. A placebo for tirilazad is also administered.
A second group receives the same MePRDL loading dose but the continuous infusion is maintained for 48 hours. A placebo for tirilazad is also administered.
A third group receives a 48-hour infusion of tirilazad with an initial bolus dose of MePRDL. Eight additional doses of tirilazad are administered by intravenous push. The MePRDL loading dose may be omitted for patients who received a prestudy MePRDL dose.
Patients are followed at 72 hours, 6 weeks, 6 months, and 1 year after the injury.
Eligibility
| Ages Eligible for Study: | 14 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| National Institute of Neurological Disorders and Stroke (NINDS) |
| Yale University |
| Study Chair: | Michael Bracken | Yale University |
More Information
| Study ID Numbers: | 199/11692, YALESM-5908 |
| First Received: | February 24, 2000 |
| Last Updated: | September 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004759 |
| Health Authority: | United States: Federal Government |
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