At a glance
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A Phase 3, Prospective, Multicenter, Double Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of Eculizumab in Patients With Guillain-Barré Syndrome (GBS)
In Brief
A Phase 3 clinical trial evaluating Eculizumab and Placebo for Guillain-Barre Syndrome. Completed, enrolled 57 participants across 22 sites.
Detailed Summary
This is a Phase 3, prospective, multicenter, placebo controlled, double blind, randomized study to investigate the efficacy and safety of eculizumab in participants with severe GBS, defined using the Hughes Functional Grade (FG) scale as progressively deteriorating FG3 or FG4/FG5 within 2 weeks from onset of weakness due to GBS. This study will be conducted only at sites in Japan.
Study Details
Timeline
Interventions
Eculizumab will be administered via IV infusion once a week for 4 weeks.
Placebo will be administered via IV infusion once a week for 4 weeks.