The EXPLORE MG Registry for Myasthenia Gravis

Sponsor

Yale University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03792659

Collaborator

(none)

800

Enrollment

Location

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Myasthenia Gravis	Other: Blood Sample Draw

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

800 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Mar 30, 2016

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Mar 30, 2024

Arms and Interventions

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

Arm

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.

Other: Blood Sample Draw

Approximately 100 cc (less than 1/2 cup) of blood will be drawn from both groups.

Outcome Measures

Primary Outcome Measures

The number of successful blood draws will be reported at the conclusion of the sample collection [8 years]
Successful Collection of Blood

Secondary Outcome Measures

The number of stool samples collected will be reported at the conclusion of the sample [8 years]
Count of Stool Samples

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale-New Haven Hospital	New Haven	Connecticut	United States	06510

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator: Richard Nowak, MD, MS, Assistant Professor, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yale University

ClinicalTrials.gov Identifier:

NCT03792659

Other Study ID Numbers:

1602017284

First Posted:

Jan 3, 2019

Last Update Posted:

Dec 16, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myasthenia Gravis

Muscle Weakness

Study Results

No Results Posted as of Dec 16, 2021