Clinical Trial: Mycophenolate Mofetil in Myasthenia Gravis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Trial of Mycophenolate Mofetil in Myasthenia Gravis

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 Summary: 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.
Sponsor: FDA Office of Orphan Products Development

Current Primary Outcome: QMGS

Original Primary Outcome:

Current Secondary Outcome: Multiple

Original Secondary Outcome:

Information By: FDA Office of Orphan Products Development

Dates:
Date Received: January 31, 2006
Date Started: September 2002
Date Completion:
Last Updated: March 24, 2015
Last Verified: March 2007