Studies & Trials

Myasthenia Gravis

A Phase 2 Trial of Rituximab in Myasthenia Gravis (HIC #1401013253)

The purpose of this trial is to evaluate the safety and benefit of rituximab in patients with AChR antibody positive generalized myasthenia gravis (MG). This is a prospective, randomized, double-blind, placebo-controlled, multi-center study sponsored by the National Institutes of Health (NIH). The study will be completed within the NeuroNEXT clinical trials network.

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Clinical Trial Details

Efficacy and Safety of IGIV-C in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis (GTI 1306) (HIC #1509016449)

This is a prospective, randomized, double-blind, placebo-controlled, multi-center study sponsored by Grifols Therapeutics, Inc. The primary objective of this study is to evaluate the efficacy of IV infusions of IGIV-C as compared to placebo in reducing the maintenance dosage of corticosteroids in subjects with myasthenia gravis that are dependent on corticosteroids. This phase 2 study will enroll 60 people between the ages of 18 and 85 across the U.S., Canada, and Europe. Participants must be diagnosed with generalized MG, require systemic corticosteroid therapy for at least the preceding three months prior to screening, and meet other study criteria. The study will last 45 weeks.

Clinical Trial Details

A Study to Evaluate the Efficacy and Safety of IGIV-C in Symptomatic Subjects with Generalized Myasthenia Gravis (GTI 1408) (HIC #1508016281)

This is a prospective, randomized, double-blind, placebo-controlled, multi-center study sponsored by Grifols Therapeutics, Inc. This study is designed to look at how well IGIV-C as compared with placebo improves muscle weakness associated with MG symptoms. Eligible participants must be receiving standard of care MG treatment while continuing to have symptoms of MG as demonstrated by a QMG ≥ 10 points. Participants will receive IGIV-C along with their usual MG medications to determine whether IGIV-C can improve MG symptoms compared to maintaining current MG medications without the addition of immunoglobulin. This phase 2 study will enroll 62 people between the ages of 18 and 85 across the U.S., Canada, and Europe. The study will last 24 weeks.

Clinical Trial Details

A Phase 3 Trial of Eculizumab in Refractory Generalized Myasthenia Gravis (HIC #1403013538)

The purpose of this trial is to evaluate the safety and efficacy of eculizumab in patients with refractory generalized myasthenia gravis. This is a prospective, randomized, double-blind, placebo-controlled, multi-center study sponsored by Alexion Pharmaceuticals. The study will be conducted at approximately 100 centers worldwide.

Clinical Trial Details

ECU-MG-302: A Phase 3 Open-Label Extension Trial of ECU-MG-301 (HIC #1501015161)

The purpose of this trial is to determine if eculizumab is safe and effective for the treatment of refractory generalized Myasthenia Gravis (gMG).  This study is an open-label study that will follow the blinded ECU-MG-301 study. After a four-week, blinded induction phase, participants will receive the active study drug, eculizumab.   Only people who have participated in the ECU-MG-301 study will be eligible to join this study.  


Clinical Trial Details

Immunologic Markers of Myasthenia Gravis (HIC# 0911006001)

The purpose of the exploratory research study is to collect blood samples from people with myasthenia gravis (MG).  Through analysis of these specimens, the researcher hope to learn more about the underlying pathophysiology of MG, as well as find unique biological markers, which could be used to develop new therapies.

Efficacy of Prednisone in the Treatment of Ocular Myasthenia: The EPITOME Study (HIC# 1211011140)

The purpose of this study is to determine if prednisone is an effective therapy for newly diagnosed ocular myasthenia gravis (OMG) patients, in addition to pyridostigmine. This is a randomized, double-blind, placebo controlled study.

Immunologic Biomarkers in the Efficacy of Prednisone in the Treatment of Ocular Myasthenia: The IB-EPITOME Study (HIC#1302011501)

This is an ancillary biomarker study for the EPITOME study. Subjects participating in the EPITOME study can also enroll in IB-EPITOME. The purpose of this study is to explore how treatment modifies the immunopathology of ocular myasthenia gravis and to identify markers of disease activity.

Inflammatory Neuropathies

The International Guillain-Barré syndrome Outcome Study (IGOS) (HIC# 1302011440)

IGOS is a worldwide prospective study, conducted by the Inflammatory Neuropathy Consortium (INC), that aims to define biomarkers for disease activity and recovery and to develop prognostic models to predict the clinical course and outcome in individual patients with Guillain-Barré syndrome (GBS). The study will enroll 1000 subjects from over 100 centers.

Clinical Trial Details

Immunologic Markers of Immune Mediated Neuropathies (HIC# 0911006001)

The purpose of the exploratory research study is to collect blood samples from people with chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy (MMN). Through analysis of these specimens, the researchers hope to learn more about the underlying pathophysiology of CIDP/MMN, as well as find unique biological markers, which could be used to develop new therapies and guide treatment strategies.

Inflammatory Myopathies

Immunologic Mechanisms of Inclusion Body Myositis (IBM) (HIC# 0911006001)

The purpose of the exploratory research study is to collect blood samples from people with inclusion body myositis (IBM). Through analysis of these specimens, the researchers hope to learn more about the underlying pathophysiology of IBM, as well as find unique biological markers, which could be used to guide treatment strategies.

What is Myasthenia Gravis?

What is Myasthenia Gravis?

from Kindea Labs