The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies. Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments. The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.


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 Criteria:

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

Study Design: