Overview

ECU-MG-302: A Phase III, Open-Label, Extension Trial of ECU-MG-301 to Evaluate the Safety and Efficacy of Eculizumab in Subjects with Refractory Generalized Myasthenia Gravis
(status: not yet recruiting)
Trial ECU-MG-301, a phase III clinical trial, has been initiated to evaluate the safety and efficacy of eculizumab in the treatment of refractory generalized myasthenia gravis. The ECU-MG-302 extension trial is designed to provide the subjects who have participated in the ECU-MG-301 trial an opportunity to receive eculizumab and to collect clinical data that will provide long-term safety and efficacy information on eculizumab in subjects with refractory generalized myasthenia gravis. Study visits will be performed at the University of Miami and study participation will extend over a period of up to 4 years.

ECU-MG-301: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis
(status: currently recruiting)
The goal of this international phase III trial is to determine whether eculizumab is a safe and effective therapy for patients with generalized myasthenia gravis and whose symptoms have proven refractory to other treatments. Patients will be randomized to receive intravenous infusions of either eculizumab or placebo. Study visits will be performed at the University of Miami and study participation will extend over a period of about 34 weeks.

A Phase II Trial of Rituximab in Myasthenia Gravis
(status: currently recruiting)
The purpose of the research study is to learn whether rituximab vs. placebo is a safe therapy and helpful for people with MG. Fifty people will be enrolled and will take part in the study for 52 weeks. 25 participants will receive rituximab and 25 participants will receive placebo (an inactive salt-water substance). Neither participants nor the study team will know if who is receiving the study drug or the placebo.

Efficacy of Prednisone in the Treatment of Ocular Myasthenia (EPITOME)
(status: ongoing, not recruiting)
This is a randomized, controlled trial of adjustable dose prednisone in patients with ocular myasthenia gravis. Ocular myasthenia patients whose symptoms have not responded adequately to treatment with pyridostigmine (mestinon) are eligible to participate. Our goals are to investigate the safety and efficacy of prednisone, to identify the optimal dose of prednisone for treating patients with ocular myasthenia and to begin to learn something about whether treatment with prednisone reduces the risk of progression to generalized disease.

Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy (MGTX)
(status: ongoing, not recruiting)
This is an international multi-center randomized controlled trial of thymectomy in patients with myasthenia gravis. Patients with generalized myasthenia gravis and anti-acetylcholine receptor antibodies are eligible to participate. All study participants will receive prednisone. Half of the study population will also undergo thymectomy. Study visits are performed at the University of Miami and study participation will extend over a period of about three years.

Phase II Trial of Methotrexate in Myasthenia Gravis
(status: ongoing, not recruiting)
The goal of this phase II trial is to determine if oral methotrexate is an effective therapy for myasthenia gravis patients who are prednisone-dependent. Patients will be randomized to receive either methotrexate or placebo and will continue to receive prednisone. After a period of several months, efforts will be made to reduce the dosage of prednisone. The hypothesis is that adding methotrexate therapy in these patients will alleviate the symptoms of myasthenia and permit a reduction in the dosage of prednisone.

Cochrane Collaboration
(status: ongoing, not recruiting)
The Cochrane Collaboration develops systematic reviews and meta-analyses of important medical topics. In 2009 Benatar et al published a review of treatments for ocular myasthenia, which is currently in the process of being updated. We are also in the midst of preparing reviews on the topics of the treatment of orthostatic hypotension, as well as the accuracy of tests for the diagnosis of myasthenia gravis.

Myasthenia Gravis Genome Wide Association Study (GWAS)
(status: closed to enrollment)
This is a multi-center collaborative study in which we aim to collect DNA samples from approximately 1100 people with seropositive generalized myasthenia gravis. These DNA samples will be used to perform a genome wide association study with the goal of identifying genetic factors that contribute to myasthenia gravis.

Safety & Efficacy Study of Eculizumab in Patients with Refractory Generalized Myasthenia Gravis (Eculizumab)
(status: closed to enrollment)
This is a multi-center randomized, controlled trial on Eculizumab in patients with generalized myasthenia that has been refractory to immune-suppressive therapy. This is a cross-over study, which means that all participants will receive active drug at some point in the study. This trial is sponsored by Alexion Pharmaceuticals.

(information last updated: January 14, 2014 )