The EXPLORE MG Registry for Myasthenia Gravis

Myasthenia Gravis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03792659
• Other study ID #: 1602017284
• Status: Recruiting
• Start date: March 30, 2016
• Est. completion date: October 30, 2026

Study information

• Verified date: August 2023
• Source: Yale University
• Contact: Bailey Sheldon, PhD
• Phone: 203-737-7095
• Email: bailey.munrosheldon[@]yale.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: October 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis

Intervention

Other:
• Blood Sample Draw
Approximately 100 cc (less than 1/2 cup) of blood will be drawn from both groups.

Locations

Country	Name	City	State
United States	Yale-New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Anil R, Kumar A, Alaparthi S, Sharma A, Nye JL, Roy B, O'Connor KC, Nowak RJ. Exploring outcomes and characteristics of myasthenia gravis: Rationale, aims and design of registry - The EXPLORE-MG registry. J Neurol Sci. 2020 Jul 15;414:116830. doi: 10.1016/j.jns.2020.116830. Epub 2020 Apr 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of successful blood draws will be reported at the conclusion of the sample collection	Successful Collection of Blood	8 years
Secondary	The number of stool samples collected will be reported at the conclusion of the sample	Count of Stool Samples	8 years