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A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG)

Myasthenia Gravis Clinical Trial

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

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of eculizumab in the treatment of pediatric refractory gMG based on change from Baseline in the Quantitative Myasthenia Gravis (QMG) score for disease severity.

Clinical Trial Description

The study will consist of an up to 4-week Screening Period, 26-week Primary Evaluation Treatment Period, an additional (up to) to 208-week Extension Period, and an 8-week Safety Follow-up Period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03759366
Study type Interventional
Source Alexion Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 3
Start date December 21, 2018
Completion date November 6, 2023
View Details
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