NCT00727194

Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis

A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study of Eculizumab in Patients With Generalized Myasthenia Gravis (gMG) Who Have Moderate to Severe Muscle Weakness Despite Treatment With Immunosuppressants

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of patients with generalized myasthenia gravis despite treatment with various immunosuppressants, such as prednisone, methotrexate, Cellcept, cyclosporine, and cyclophosphamide, that are currently available.

Conditions

• Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	eculizumab	eculizumab 600 mg IV weekly for 4 doses followed by eculizumab 900 mg IV every two weeks for 7 doses
DRUG	Placebo	Placebo IV weekly for 4 doses then every two weeks for 7 doses

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-03-01
• Completion: 2011-07-01
• First posted: 2008-08-01
• Last updated: 2019-09-24
• Results posted: 2016-12-12

Locations

25 sites across 3 countries: United States, Canada, United Kingdom