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Methylprednisolone Given by 24-Hour or 48-Hour Infusion Versus Tirilazad for Acute Spinal Cord Injury

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004759
First Posted: February 25, 2000
Last Update Posted: September 10, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Yale University
Information provided by:
Office of Rare Diseases (ORD)
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase III Randomized, Double-Blind Study of Methylprednisolone by 24- Versus 48-Hour Infusion Versus Tirilazad for Acute Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 497
Study Start Date: December 1991
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004759


Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Yale University
Investigators
Study Chair: Michael Bracken Yale University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00004759     History of Changes
Other Study ID Numbers: 199/11692
YALESM-5908
First Submitted: February 24, 2000
First Posted: February 25, 2000
Last Update Posted: September 10, 2008
Last Verified: September 2008

Keywords provided by Office of Rare Diseases (ORD):
environmental/toxic disorders
neurologic and psychiatric disorders
rare disease
spinal cord injury

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Tirilazad
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action