Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004759
Status:
COMPLETED
Last Update Posted:
2008-09-10
First Post:
2000-02-24
Brief Title:
Methylprednisolone Given by 24-Hour or 48-Hour Infusion Versus Tirilazad for Acute Spinal Cord Injury
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
Phase III Randomized Double-Blind Study of Methylprednisolone by 24- Versus 48-Hour Infusion Versus Tirilazad for Acute Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| YALESM-5908 | None | None | None |