NCT00285350

Mycophenolate Mofetil in Myasthenia Gravis

A Trial of Mycophenolate Mofetil in Myasthenia Gravis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (planned)
• Sponsor: FDA Office of Orphan Products Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 2.5 gm MM/day (1,250 mg q 12 hours, +/- 2 hours) plus 20 mg prednisone/day versus placebo plus 20 mg/day 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.

Conditions

• Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	mycophenolate mofetil

Timeline

• Start date: 2002-09-01
• Completion: 2007-03-01
• First posted: 2006-02-02
• Last updated: 2015-03-25