Not yet recruiting

ClinicalTriails.gov ID: NCT07224386

Sponsor: BioSensics

Evaluate the feasibility of using digital health technologies to monitor symptoms in myasthenia gravis (MG).

Study subjects will be screened and enrolled at Massachusetts General Brigham Hospital to participate in this 12 month observational study. Study subjects will be asked to wear multiple wearable sensors to monitor their physical activity and PPG during daily activities. Participants will also complete speech, video, and ePRO and eCOA digital assessments at home and during study visits.

The primary objective for this observational study is to measure the correlation of sensor-derived measures of physical activity to MG-specific ratings of MG-ADL, QMG, MGC, and Neuro-QoL Fatigue

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Recruiting

ClinicalTriails.gov ID: NCT07250750

Sponsor: ImmunAbs Inc.

The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and potential efficacy of IM-101 in adult participants with AChR antibody-positive gMG. Subsequently, the safety and efficacy of the selected IM-101 dose-regimen will be tested in participants with AChR antibody-negative gMG and participants with AChR antibody-positive or AChR antibody-negative oMG.

A Phase 1b/2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate A) the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of IM-101 in Adult Participants With Generalized Myasthenia Gravis, and B) the Efficacy and Safety of Treatment of IM-101 in Adult Participants With Generalized Myasthenia Gravis and Ocular Myasthenia Gravis.

Current Locations: United States

Florida Locations

Altamonte Springs, Florida, United States, 32714

Recruiting

Neurology of Central Florida Research Center, LLC

Boca Raton, Florida, United States, 33487

Recruiting

SFM Clinical Research, LLC

Texas Locations

Houston, Texas, United States, 77030

Recruiting

Nerve & Muscle Center of Texas

Houston, Texas, United States, 77070

Not yet recruiting

Houston Methodist Neurological Institute

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Recruiting

ClinicalTriails.gov ID: NCT06414954

Sponsor: NMD Pharma A/S

This Phase 2 proof-of-concept, dose range finding study aims to evaluate the safety and efficacy of 3 dose levels of NMD670 vs placebo in adult patients with MG with antibodies against AChR or MuSK, administered twice a day (BID) for 21 days.

A Phase 2b, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 3 Dose Levels of NMD670 Over 21 Days in Adult Patients With AChR/MuSK-Ab+ Myasthenia Gravis

Current Locations: United States

California Locations

Irvine, California, United States, 92868

Recruiting

University of California Irvine Medical Center

Aurora, Colorado, United States, 80045

Recruiting

University of Colorado Neuromuscular Division

Recruiting

ClinicalTriails.gov ID: NCT06193889

Sponsor: Kyverna Therapeutics

A Study of the Anti-CD 19 Chimeric Antigen Receptor T Cell Therapy for Patients with Myasthenia Gravis.

Myasthenia gravis (MG) is a chronic autoimmune disease that affects the neuromuscular junction and is characterized by muscle weakness. B cells play a role in MG, and the disease is characterized by the presence of autoantibodies such as anti-AChR and anti-MuSK antibodies. CD-19 target chimeric antigen receptor (CAR) T cells harness the ability of cytotoxic T cells to directly and specifically lyse target cells to effectively deplete both normal and autoreactive B cells in the circulation as well as impacted lymphoid and potentially non-lymphoid tissues. KYV-101, a fully human anti-CD19 CAR T-cell therapy, will be investigated in adult subjects with myasthenia gravis (MG).

KYSA-6: A Phase 2/3, Open-Label, Randomized, Controlled, Multicenter Study of KYV-101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T-cell (CD19 CAR T) Therapy, Versus Ongoing Standard-Of-Care Immunosuppressive Therapy in Patients With Generalized Myasthenia Gravis

United States Locations

California Locations

Orange, California, United States, 92868

Recruiting

University of California, Irvine

Recruiting

ClinicalTriails.gov ID: NCT06491238

Sponsor: HealthPartners Institute

The overall purpose of this pilot study is to examine the feasibility, acceptability, and tolerability of light and moderate intensity exercise in adults with MGeffect of light vs. moderate intensity exercise on health outcomes. Participants will be enrolled into the NeuroWell exercise program, which is geared toward individuals with neurological disorders or injuries and led by Certified Exercise Physiologists (CEPs) at the HealthPartners Neuroscience Center. A total of 20 people with MG will be enrolled in this study and participate in a small group exercise program 3 times a week for 12 weeks. Participants will be randomized into two exercise groups: 1) Light intensity or 2) Moderate intensity. We hypothesize that light and moderate intensity exercise will be feasible, acceptable, and tolerable in adults with MG and that individuals in the light intensity exercise group will be able to achieve the same improvement in health outcomes as the moderate intensity group.

Light vs. Moderate Intensity Exercise in Individuals With Myasthenia Gravis

United States Locations

Minnesota Locations

Saint Paul, Minnesota, United States, 55130

Recruiting

HealthPartners Neuroscience Center

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Unknown Status 

ClinicalTriails.gov ID: NCT06277830

Sponsor: Massachusetts General Hospital

The goal of this observational study is to evaluate the feasibility of using wearable sensor and digital technologies to measure motor and speech function in adults with autoimmune Myasthenia Gravis (MG).

The main question[s] it aims to answer are:

• To measure the correlation of sensor-based measures of motor function with existing outcome measures including the MG-ADL, MGQOL15r, QMG, MGComposite, and Neuro-QOL Fatigue scales.
• To develop and validate tablet-based digital assessments of speech and facial expression and to compare with existing outcome measures.

Participants will wear a pendant sensor for 7 days and then participate in tablet-based and in-person myasthenia-specific physical examinations. This will be performed in concert with routine care in the Massachusetts General Hospital MG clinic.

Wearable Sensor and Digital Technologies for Quantitative Assessment and Remote Monitoring of Symptoms in Myasthenia Gravis

United States Locations

Massachusetts Locations

Boston, Massachusetts, United States, 02114

Recruiting

Massachusetts General Hospital

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Recruiting

ClinicalTriails.gov ID: NCT07217587

Sponsor: Janssen Research & Development, LLC

The purpose of this study is to assess how well nipocalimab works when compared to efgartigimod in participants with generalized myasthenia gravis (a condition in which body's immune system mistakenly attacks and damages the connection between nerves and muscles causing muscle weakness).

Efficacy and Safety of Nipocalimab vs Efgartigimod for Patients With Generalized Myasthenia Gravis in a Randomized, Open-label, Phase 3b, Interventional Trial Including Within Class Switching From Efgartigimod to Nipocalimab

United States Locations

Florida Locations

Boca Raton, Florida, United States, 33487

Recruiting

SFM Clinical Research LLC

Illnois Locations

O'Fallon, Illinois, United States, 62269

Recruiting

HSHS St. Elizabeth's Hospital

Michigan Locations

Detroit, Michigan, United States, 48202

Recruiting

Henry Ford Hospital

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Recruiting

ClinicalTriails.gov ID: NCT05564936

Sponsor: Ad scientiam

ME&MG is a standalone software (digital solution) running on patients smartphones, connected to a web portal for physicians. It is intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG.

ME&MG contains digital active tests for the assessment of ptosis, breathing, dysarthria, upper- and lower-limb (arms and legs) weakness, treatment follow-up, and validated e-questionnaires related to daily activities, pain, fatigue, sleep, and depression disorders.

The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone with ME&MG versus the standard in-clinic testing, as well as to evaluate the safety of the solution, its usability and satisfaction.

The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis: a Validation Study

United States Locations

Colorado Locations

Aurora, Colorado, United States, 80204

Recruiting

University of Colorado Denver

Contact : Thomas Ragole, Dr

Recruiting

ClinicalTriails.gov ID: NCT06860633

Sponsor: University of Colorado, Denver

This study plans to learn more about if the drug efgartigimod can be used in the hospital to treat exacerbations in participants with myasthenia gravis (MG). Efgartigimod has been approved by the FDA for ongoing (chronic) treatment of generalized MG in adult patients who are anti-acetylcholine receptor (AChR) antibody positive but has not been studied in the treatment of worsening weakness requiring hospital admission (known as "exacerbation"). This investigation aims to see if using efgartigimod in this way improves symptoms and recovery from exacerbation, and how it affects certain MG markers in the blood. The main questions it aims to answer are:

• Is efgartigimod effective as a hospital-administered acute therapy for participants with worsening MG (MG exacerbation) who require hospitalization?
• Will efgartigimod lead to clinical improvement with a similar reduction in validated research scales, such as the Quantitative MG (QMG) scale, as standard of care therapies?

Participants will receive 4 doses of efgartigimod over the course of 4 weeks with an additional follow-up visit at the clinic.

Treatment of Myasthenia Gravis Exacerbation or Crisis With Efgartigimod: A Single Arm, Open Label Prospective Cohort Study

United States Locations

Colorado Locations

Aurora, Colorado, United States, 80045

Recruiting

University of Colorado

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Recruiting

ClinicalTriails.gov ID: NCT03792659

Sponsor: Yale University

The purpose of this study is to create a Yale University Department of Neurology Myasthenia Gravis (MG) registry that will be used for current and future research projects involving the study of Myasthenia Gravis. This registry will allow for the research of several mechanisms of Myasthenia Gravis (MG) by studying peripheral blood, stool, disease status and course, and treatment of subjects with MG. The EXPLORE-MG Registry focuses on varied aspects of MG such as disease management, health care utilization, health costs, disease characteristics, and diagnostic tools. As such, it will aid in a broader understanding of MG, while providing a registry from which questions about the disease may be better answered. 

Exploring Outcomes and Characteristics of Myasthenia Gravis: The EXPLORE MG Registry

United States Locations

Connecticut Locations

New Haven, Connecticut, United States, 06510

Recruiting

Yale-New Haven Hospital

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Recruiting

ClinicalTriails.gov ID: NCT06064461

Sponsor: Vitaccess Ltd

Vitaccess Real MG (VRMG) is a patient registry designed to capture longitudinal observational data on myasthenia gravis (MG), its treatment, and impact on symptoms, daily activities, and quality of life (QoL). The duration of the registry is 10 years from launch, and approximately 600 patients will be recruited in the US and Europe with no defined upper limit. The registry will link relevant patient- and healthcare professional (HCP)-reported data with clinical data from medical records.

Patients will be recruited at clinical sites in all participating countries. In the US only, patients can additionally be recruited via community neurologists or direct-to-patient recruitment.

Vitaccess Real MG Registry: A Prospective International Observational Patient Registry in Myasthenia Gravis Linking Clinical and Patient-reported Data.

United States Locations

California Locations

Orange, California, United States, 92868

Recruiting

UCI Health

Recruiting

ClinicalTriails.gov ID: NCT07478172

Sponsor: University of Missouri-Columbia

This single-arm pilot study evaluates the effects of whole-body electrical muscle stimulation (WB-EMS) exercise on neuromuscular and physical function in adults with neuromuscular disease (NMD). Due to motor unit impairments, NMD patients often cannot tolerate traditional exercise. WB-EMS bypasses voluntary activation limits by directly stimulating muscle contractions. Up to 50 adults with conditions like ALS, SMA, and MG will undergo 20-minute supervised WB-EMS sessions (1-2 times weekly for 4-8 weeks) using the Katalyst system. Outcomes include neural excitability (TMS), motor unit behavior (EMG, NCS), functional tests (walk, balance, strength), and patient-reported fatigue, pain, and quality of life. Strict safety monitoring and exclusion criteria are in place. This study will provide preliminary data on WB-EMS as a potential exercise modality for NMD.

United States Locations

Missouri Locations

Columbia, Missouri, United States, 65211

Recruiting

NextGen Precision Health Building, Clinical and Translational Science Unit

Recruiting

ClinicalTriails.gov ID: NCT01793168

Sponsor: Sanford Health

CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases. This program allows patients and researchers to connect as easily as possible to help advance treatments and cures for rare diseases. The CoRDS team works with patient advocacy groups, individuals and researchers to help in the advancement of research in over 7,000 rare diseases. The registry is free for patients to enroll and researchers to access. Visit sanfordresearch.org/CoRDS to enroll.

United States Locations

South Dakota Locations

Sioux Falls, South Dakota, United States, 57104

Recruiting

Sanford Health