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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
| Sponsor |
Alexion Pharmaceuticals, Inc. |
| Site-PI |
Michael Benatar, MD, PhD |
| Summary |
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 gMG. 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. |
| Eligibility criteria |
- Subjects who have completed the ECU-MG-301 trial.
- No pregnancy or breast-feeding
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| Funding agency |
Alexion Pharmaceuticals, Inc. |
| Project manager |
Sara-Claude Michon |
| Contact information |
Email:
Phone: (305) 243-6481
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| Links |
http://clinicaltrials.gov/ct2/show/NCT01997229?term=eculizumab+and+myasthenia&rank=2 |
| Presentations / Publications |
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