Clinical Trials Logo
  1. Home
  2. Myasthenia Gravis, Generalized
  3. NCT03759366

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
See also
  Status Clinical Trial Phase
Completed NCT05039190 - Evaluate the Efficacy and Safety of HBM9161(HL161)Subcutaneous Injection in Patients With Generalized MG Patients Phase 3
Recruiting NCT04561557 - Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System Early Phase 1
Completed NCT01727193 - The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand Thymectomy Phase 3
Completed NCT00285350 - Mycophenolate Mofetil in Myasthenia Gravis Phase 3
Recruiting NCT05890833 - The Risk of Falls Index for Patients With Neuromuscular Disorders
Completed NCT05694234 - Influences of Sugammadex on Postoperative Progress in Patients With Myasthenia Gravis Undergoing Video-assisted Thoracoscopic Thymectomy: Retrospective Study
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Not yet recruiting NCT05095103 - Immune Profiles in Myasthenia Gravis
Not yet recruiting NCT04965987 - Oxaloacetate in Myasthenia Gravis Phase 1
Completed NCT02066519 - Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis N/A
Terminated NCT02102594 - Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB) Phase 2
Completed NCT02774239 - A Pilot Trial To Assess The Feasibility And Efficacy Of SCIG In Patients With MG Exacerbation (SCIG-MG) Phase 3
Completed NCT02118805 - Innovative Measures of Speech and Swallowing Dysfunction in Neurological Disorders
Terminated NCT01828294 - Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis Phase 1
Terminated NCT00727194 - Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis Phase 2
Completed NCT04590716 - Help Build an A.I. Model to Predict Myasthenia Gravis Symptom Patterns and Flares
Recruiting NCT04837625 - Study of Myasthenic Crisis in China
Not yet recruiting NCT01469858 - Perception and Multisensory Integration in Neurological Patients Using fMRI N/A
Completed NCT05408702 - Exercise in Autoimmune Myasthenia Gravis and Myasthenic Syndromes
Completed NCT03205306 - Myasthenia Gravis and Psyche