Clinical Trials Logo
  1. Home
  2. Guillain-Barre Syndrome
  3. NCT04752566

A Study to Evaluate the Efficacy and Safety of Eculizumab in Guillain-Barré Syndrome

Guillain-Barre Syndrome Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial Description

Eligible participants will be randomized to receive intravenous (IV) infusion of eculizumab or placebo at a 2:1 ratio. All participants will be on concomitant IV immunoglobulin G (Ig) therapy as per standard of care. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04752566
Study type Interventional
Source Alexion Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 3
Start date March 8, 2021
Completion date August 3, 2022
View Details
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04053452 - Peripheral Nerve Ultrasound for Diagnosis and Prognosis of Guillain-Barre Syndrome N/A
Recruiting NCT02582853 - sCD163 as a Potential Biomarker in Guillain- Barré Syndrome N/A
Completed NCT00056810 - Assessment of Chronic Guillain-Barre Syndrome Improvement With Use of 4-aminopyridine Phase 2
Completed NCT05104762 - IVIG Versus Plasmapheresis in the Treatment of Guillian Barrie Syndrome Patients Phase 2/Phase 3
Recruiting NCT05630313 - Gene Sequencing as a Strategy for Identifying Genetic Factors Associated With Serious Adverse Events After Covid-19 Vaccines in Use in Brazil
Recruiting NCT03801135 - Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation N/A
Active, not recruiting NCT01655394 - Change of Nerve Conduction Properties in IVIg Dependent Neuropathies N/A
Completed NCT04927598 - Predictors and Prognostic Factors of Gullian Barrie Syndrome Outcome
Completed NCT06334796 - Artificial Intelligence-powered Virtual Assistant for Emergency Triage in Neurology Early Phase 1
Not yet recruiting NCT04092140 - Neuromuscular Ultrasound in Correlation to Neurophysiological Findings
Not yet recruiting NCT04550611 - Mini-pool Intravenous Immunoglobulin (MP-IVIG) in Guillain-Barré Syndrome N/A
Withdrawn NCT03268304 - Feasibility of Two New Software Modules for the Rehabilitation of Patients With Neuromuscular Upper Limb Impairments
Not yet recruiting NCT05701189 - Evaluating Efgartigimod in Patients With Guillain-Barré Syndrome Phase 2
Withdrawn NCT02459808 - Gastrointestinal Transit Time in Patients With Guillain-Barré Syndrome N/A
Completed NCT05292690 - An Assistive Powered Wheelchair: Stage 2 Trial
Not yet recruiting NCT06300359 - Prognostic Indicators of Gullian-Barre Syndrome
Completed NCT00575653 - Safety Study of GBS Following Menactra Meningococcal Vaccination N/A
Completed NCT05491096 - Effects of Proprioceptive Neuromuscular Training on Sensory and Motor Function in Guillain Barre Syndrome N/A
Not yet recruiting NCT05114941 - Comparison of the Efficacy and Safety of Immunoadsorption and Intravenous Immunoglobulin for Guillain-Barre Syndrome N/A
Completed NCT05945784 - Exploring Accessible Beauty for Individuals With Upper Extremity Deficits