Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285350
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2006-01-31
Brief Title:
Mycophenolate Mofetil in Myasthenia Gravis
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
A Trial of Mycophenolate Mofetil in Myasthenia Gravis
Status:
COMPLETED
Status Verified Date:
2007-03
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:
This is a prospective multi-center double-blind placebo-controlled trial to determine the efficacy and safety of mycophenolate mofetil MM in combination with prednisone as the initial form of immunosuppression in patients with acquired myasthenia gravis MG
Detailed Description:
80 patients with seropositive MG at 18 academic centers will be randomized to 3 months of treatment with 25 gm MMday 1250 mg q 12 hours - 2 hours plus 20 mg prednisoneday versus placebo plus 20 mgday prednisone The primary measure of efficacy will be the change from baseline in Quantitative MG QMG score at the end of 3 months Secondary outcome measures include survival analysis for treatment failure MG-related impairment of daily activities functional assessment manual muscle testing SF-36 Health Status and serum concentration of antibodies to the acetylcholine receptor Study completers will have the option of taking open-label MM for an additional 6 months during which prednisone will be reduced to the lowest dose necessary to maintain the optimum clinical response
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