Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00418145
Status:
TERMINATED
Last Update Posted:
2017-05-18
First Post:
2007-01-02
Brief Title:
Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis Attacks
Sponsor:
Fred Lublin
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Oral Megadose Corticosteroid Therapy of Acute Exacerbations of Multiple Sclerosis OMEGA
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low enrollment - data was not analyzed for this study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial compares the relative efficacy of treating acute exacerbations of relapsing forms of Multiple Sclerosis with equivalent doses of oral and intravenous IV methylprednisolone This is a randomized blinded multi-center study
Detailed Description:
Intravenous methylprednisolone has been the standard of care for treating acute MS flares However the IV administration is cumbersome inconvenient and expensive A true comparison of these different approaches has not been undertaken in rigorous fashion Prior studies have demonstrated the safety of such high doses of oral steroid For this proposal we employ equivalent oral dosing 1400 mgday and compare that to 1000 mgday IV therapy in patients seen within seven days of an acute exacerbation of MS
In addition there are 2 arms to this double-blind placebo controlled randomized trial One arm has an active IV and an oral placebo while the second arm has an IV placebo and an active oral dose Therefore each subject will receive an active treatment
In addition there are 2 arms to this double-blind placebo controlled randomized trial One arm has an active IV and an oral placebo while the second arm has an IV placebo and an active oral dose Therefore each subject will receive an active treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RG 3363A8 | None | None | None |