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Myasthenia Gravis clinical trials

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NCT ID: NCT04728425 Recruiting - Myasthenia Gravis Clinical Trials

Subcutaneous Immunoglobulin for Myasthenia Gravis

MG_SCIG
Start date: August 28, 2020
Phase: Phase 2
Study type: Interventional

This is a prospective open-label, randomized, parallel arm clinical trial. The primary objective of the study is to evaluate the safety and efficacy of Cuvitru 20% subcutaneous immunoglobulin in patients with myasthenia gravis (MG). The secondary objective is to evaluate patient preferences and effects on quality of life when treating MG patients with SCIG. Exploratory objectives are to compare de novo administration starting SCIG directly with those starting with a loading dose of IVIG followed by SCIG administration. Patients over age 18 with moderate to severe MG with MGFA Class II-IV without contraindications to immunoglobulin will be considered for the study. All patients will be eligible to enter either arm of the study, Arm 1: 10% Gammagard IVIG followed by 20% Cuvitry SCIG and Arm 2: Cuvitru 20% SCIG alone.

NCT ID: NCT04695379 Completed - Myasthenia Gravis Clinical Trials

Follow-up of a Cohort of Patients With Myasthenic Syndrome and COVID-19 Infection

CO-MY-COVID
Start date: April 27, 2020
Phase:
Study type: Observational

Coronavirus disease 2019 (COVID-19), declared by the World Health Organization (WHO) as a "public health emergency of international concern" (January 31, 2020), has posed a significant threat to global health. This infectious disease, caused by the 'severe acute respiratory syndrome coronavirus-2'(SARS-CoV-2), was first reported in China at the end of 2019. As other coronaviruses, SARS-CoV-2 primarily targets the human respiratory system. The most common symptoms are fever, fatigue, and dry cough. During the second week of the disease, part of patients may progress to shortness of breath, then hypoxemia and severe pneumonia. Acute respiratory distress syndrome (ARDS), linked to some risk factors such as advanced age and underlying comorbidities (hypertension, diabetes, cardiovascular disease, and cerebrovascular disease), may be fatal and needs early supportive therapy and monitoring. Some patients with COVID-19 experienced neurological complications including headache, dizziness, hypogeusia and/or anosmia, altered level of consciousness, strokes, seizures, and ataxia, less frequently neuromuscular disorders (NMD) such as acute inflammatory polyradiculoneuropathy. Among NMD, myasthenia gravis (MG) patients, particularly susceptible to infections causing crises, could be of special risk of COVID-19 ARDS. Some general recommendations were established for the management of NMD during the COVID-19 pandemic,with also specific recommendations for MG. However, only data on a small number of patients who were managed in hospital are currently available;in addition, only two cases of myasthenic crisis following COVID-19 were reported. For this reason, the French neuromuscular rare disease network (FILNEMUS: 'FILière NEuroMUSculaire') has created the 'CO-MY-COVID register' to describe the clinical course and prognosis of patients with COVID-19 and pre-existing myasthenic syndrome.

NCT ID: NCT04678115 Active, not recruiting - Stroke Clinical Trials

Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis

Start date: June 1, 2021
Phase: N/A
Study type: Interventional

This clinical trial will evaluate two non-surgical devices designed to improve eye lid opening for patients with severe Blepharoptosis (incomplete opening of the eyelids).

NCT ID: NCT04674605 Recruiting - Myasthenia Gravis Clinical Trials

A Prospective Cohort Study Of Myasthenia Gravis

Start date: December 31, 2020
Phase:
Study type: Observational [Patient Registry]

The average annual incidence of Myasthenia gravis is up to (8.0-20.0) / 100,000 people. Myasthenia gravis is an acquired autoimmune disease. All skeletal muscles of patients may be involved. When ocular muscles are involved, ptosis, diplopia and other symptoms may occur. When the laryngopharyngeal muscles are involved, the patient may develop dysarthria, dysphagia and other symptoms. However, when the respiratory muscles are involved, patients will have difficulty in breathing, and some patients may develope myasthenia crisis, and artificial assisted respiratory therapy is often needed. This study is a prospective observational study, in which patients are continuously enrolled, basic information of patients is collected, and biological samples are collected. The purpose of this study is to improve the diagnosis and prognosis of myasthenia gravis patients.

NCT ID: NCT04667650 Completed - Clinical trials for Ocular Myasthenia Gravis

Ocular Mysathenia Gravis Generalization

MYASTEN
Start date: January 2017
Phase:
Study type: Observational

Secondary ocular myasthenia gravis (OMG) generalization represents a pejorative evolution and no validated generalization prevention strategy exists. The aim of this observational study was to determine the percentage of patients with OMG generalization and identify factors predictive of that pejorative evolution. Data from patients with OMG registered in the Fondation Hospital A. de Rothschild database between January 1990 and January 2017 were collected. Among the 183 patients registered in this database, 151 patients with available informations were analyzed.

NCT ID: NCT04650854 Completed - Clinical trials for Generalized Myasthenia Gravis

A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis

Start date: February 3, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and efficacy of additional 6-week treatment cycles with rozanolixizumab in study participants with generalized myasthenia gravis (gMG).

NCT ID: NCT04590716 Completed - Myasthenia Gravis Clinical Trials

Help Build an A.I. Model to Predict Myasthenia Gravis Symptom Patterns and Flares

Start date: October 2, 2020
Phase:
Study type: Observational

There are limited objective measurements of MG symptoms as well as a dearth of data at a granular level of MG (myasthenia gravis) symptoms and triggers occurring longitudinally. This study is designed to use the strengths of mobile smartphones which enable participant-driven real time capture of data manually and through augmented sensors such as video and audio, in order to better characterize MG symptoms and flares. The study aims to enroll approximately 200 participants for approximately 9 months until analyzable data is available from at least 100 participants. Participants will complete in-app surveys for 3 months with, audiovisual recording of symptoms. This will take approximately 35 minutes per week after the initial survey.

NCT ID: NCT04561557 Recruiting - Multiple Sclerosis Clinical Trials

Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System

CARTinNS
Start date: September 22, 2020
Phase: Early Phase 1
Study type: Interventional

Antibody-mediated inflammatory diseases of the nervous system (also known as autoimmune diseases of the nervous system) are autoimmune diseases in which autoimmune cells and immune molecules attack the nervous system as the main pathogenic mechanism. In the immune response, pathogenic antibodies acting on autoantigens of the nervous system are collectively referred to as autoantibodies of the nervous system, and antibody-mediated inflammatory diseases of the nervous system can occur in the central nervous system, peripheral nervous system, and neuromuscular junctions, and muscles. In this study, we will recruit eight kinds of autoimmune diseases of nervous system including Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathyand (IIM), multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) and POEMS Syndrome. B-cell maturation antigen (BCMA) is expressed on the surface of plasma cells, thus making it an ideal target for targeted therapies. Chimeric antigen receptor (CAR) T cells against BCMA offers another potential therapeutic option to eliminate plasma cells in patients with neurological autoimmune diseases driven by abnormal antibody who still suffer recurrent attacks from conventional treatments. In the current study, the safety and efficacy of a novel CAR-T cell therapy using CT103A cells, are evaluated in patients with relapsed/refractory antibody-mediated idiopathic inflammatory diseases.

NCT ID: NCT04541875 Withdrawn - Cystic Fibrosis Clinical Trials

Medication Adherence and Non-adherence in Adults With Rare Disease

Start date: January 2021
Phase:
Study type: Observational

The purpose of this study is to use the Medication Adherence Reasons Scale (MAR-Scale) to determine the extent of non-adherence to specific medications indicated to treat cystic fibrosis, hemophilia (A or B), idiopathic pulmonary fibrosis, myasthenia gravis, and sickle cell disease, and to identify the top patient-reported reasons for non-adherence. Internal reliability of the MAR-Scale will also be assessed in each condition.

NCT ID: NCT04535843 Recruiting - Myasthenia Gravis Clinical Trials

Precision Diagnosis and Prospective Cohort Study for Myasthenia Gravis: Multicenter Analysis in China

Start date: February 1, 2024
Phase:
Study type: Observational [Patient Registry]

The present study is a prospective cohort study aiming to improve the clinical capacity in the diagnosis and natural history of Chinese patients with myasthenia gravis (MG). 300 MG patients are planned to recruit, document and prospectively follow up. Management of screening test and cohort manifestation are studied.