- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03792659
The EXPLORE MG Registry for Myasthenia Gravis
November 21, 2025 updated by: Yale University
Exploring Outcomes and Characteristics of Myasthenia Gravis: The EXPLORE MG Registry
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.
Study Overview
Detailed Description
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.
Study Type
Observational
Enrollment (Estimated)
800
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bailey Sheldon, PhD
- Phone Number: 203-737-7095
- Email: bailey.munrosheldon@yale.edu
Study Locations
-
-
Connecticut
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New Haven, Connecticut, United States, 06510
- Recruiting
- Yale-New Haven Hospital
-
Contact:
- Bailey Munro Sheldon, PhD
- Phone Number: 203-737-7095
- Email: bailey.munrosheldon@yale.edu
-
Principal Investigator:
- Richard Nowak, MD, MS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Subjects will be 18 years of age or older with a clinical diagnosis of a Myasthenia Gravis.
Description
Inclusion Criteria:
- Adult patients diagnosed with Myasthenia Gravis presenting to the Yale Department of Neurology for clinical care or research interventions will be invited to donate their biological specimens/clinical data.
Exclusion Criteria:
- Failure to meet the Inclusion Criteria.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Neurological Outpatients
Participants in this group will be recruited from the outpatient clinical population at the Yale University Department of Neurology.
Treating physicians will make the initial determination of patients' potential eligibility to participate in the study.
|
Approximately 100 cc (less than 1/2 cup) of blood will be drawn from both groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The number of successful blood draws will be reported at the conclusion of the sample collection
Time Frame: 8 years
|
Successful Collection of Blood
|
8 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The number of stool samples collected will be reported at the conclusion of the sample
Time Frame: 8 years
|
Count of Stool Samples
|
8 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard Nowak, MD, MS, Assistant Professor, Yale University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 30, 2016
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
October 30, 2026
Study Registration Dates
First Submitted
January 2, 2019
First Submitted That Met QC Criteria
January 2, 2019
First Posted (Actual)
January 3, 2019
Study Record Updates
Last Update Posted (Estimated)
November 28, 2025
Last Update Submitted That Met QC Criteria
November 21, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Site
- Neoplasms
- Neuromuscular Diseases
- Autoimmune Diseases
- Immune System Diseases
- Autoimmune Diseases of the Nervous System
- Neurodegenerative Diseases
- Paraneoplastic Syndromes, Nervous System
- Nervous System Neoplasms
- Paraneoplastic Syndromes
- Neuromuscular Junction Diseases
- Myasthenia Gravis
Other Study ID Numbers
- 1602017284
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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