NCT00814138

Efficacy of Methotrexate in Myasthenia Gravis

Phase II Trial of Methotrexate in Myasthenia Gravis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Myasthenia gravis is a rare neuromuscular disorder characterized by weakness and fatigability of ocular, bulbar, and extremity musculature. The specific aim of this study is to determine if oral methotrexate is an effective therapy for myasthenia gravis (MG) patients who are prednisone dependent. Patients will be randomized to receive either methotrexate or placebo and those who are entered onto this trial will have symptoms and signs of the disease while on prednisone therapy. The hypothesis is that adding methotrexate therapy in these patients will improve the MG manifestations so that the prednisone dose can be reduced and clinical measures of MG severity will improve. Funding Source - FDA OOPD

Conditions

• Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	Methotrexate	10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
OTHER	Placebo	Weekly

Timeline

• Start date: 2009-04-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2008-12-24
• Last updated: 2016-05-26
• Results posted: 2015-12-23

Locations

16 sites across 2 countries: United States, Canada