drugset / Trial / NCT00814138

Efficacy of Methotrexate in Myasthenia Gravis

NCT00814138 ↗

Phase 2 Completed 50 enrolled University of Kansas Medical Center
RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start
2009-04
Primary completion
2014-01
Completion
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methotrexate Small molecule 20 mg Oral

Indications