A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Confirm the Safety,Tolerability, and Efficacy of Zilucoplan in Subjects with Generalized Myasthenia Gravis

Date Added
January 14th, 2020
PRO Number
Pro00093537
Researcher
Katherine Ruzhansky

List of Studies


Keywords
Autoimmune disease
Summary

Myasthenia gravis is an autoimmune disease; a disease that occurs when the immune system attacks the body's own tissues. In generalized myasthenia gravis (gMG), that attack interrupts the connection between nerves and muscles; called the ‘neuromuscular junction.' This study is to study the safety, tolerability and efficacy of a study drug called Zilucoplan in adult participants with gMG.

Participation in this study will last approximately 16 weeks and will include approximately 7 study visits.

Institution
MUSC
Recruitment Contact
Katrina Madden
843-792-9186
Maddenka@musc.edu

An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Eculizumab in Pediatric Patients with Refractory Generalized Myasthenia Gravis

Date Added
June 25th, 2019
PRO Number
Pro00086363
Researcher
Katherine Ruzhansky

List of Studies


Keywords
Autoimmune disease
Summary

The purpose of this study is to evaluate how safe and effective intravenous eculizumab is in pediatric patients 6 to less than 18 years old with generalized Myasthenia gravis (gMG). Eculizumab is already approved for use in adult patients with gMG in the US, Europe and Japan, but currently has not been approved for use in pediatric patients.

The study's duration is approximately 4.7 years with 4 treatment periods consisting of a Screening Period (2 to 4 weeks), Primary Evaluation Treatment Period (26 weeks), Extension Period (up to an additional 208 weeks), and Follow-up Period (8 weeks). All patients who complete Week 26 of Study ECU-MG-303 will continue receiving eculizumab in the Extension Period of this study for up to an additional 208 weeks.

Institution
MUSC
Recruitment Contact
Katrina Madden
843-792-9186
maddenka@musc.edu

PROMISE-MG: Prospective Multicenter Observational Cohort Study of Comparative Effectiveness of Disease-Modifying Treatments for Myasthenia Gravis

Date Added
September 24th, 2018
PRO Number
Pro00077927
Researcher
Katherine Ruzhansky

List of Studies


Keywords
Muscle, Nervous System
Summary

This is an observational study to develop a research registry to collect information from subjects with Myasthenia Gravis (MG) to evaluate the effects of the treatments they receive and to understand how their medical condition and treatment affects their daily life.

Institution
MUSC
Recruitment Contact
Katrina Madden
843-792-9186
maddenka@musc.edu



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