The EXPLORE MG Registry for Myasthenia Gravis | NCT03792659

Studies
The EXPLORE MG Registry for Myasthenia Gravis

NCT03792659

Sponsor

Yale University

Status

Recruiting

Last Update Posted

Nov 28, 2025Actual

Enrollment

800Estimated

Phase

Not provided

Conditions

Myasthenia Gravis

Interventions

Blood Sample Draw

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 30, 2016Actual

Primary Completion Date

Sep 30, 2026Estimated

Completion Date

Oct 30, 2026Estimated

First Submitted Date

Jan 2, 2019

First Submission Date that Met QC Criteria

Jan 2, 2019

First Posted Date

Jan 3, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2025

Last Update Posted Date

Nov 28, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

8 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

800Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood Sample Draw	Other	Approximately 100 cc (less than 1/2 cup) of blood will be drawn from both groups.	Neurological Outpatients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of successful blood draws will be reported at the conclusion of the sample collection	Successful Collection of Blood	8 years

Secondary Outcomes

Measure	Description	Time Frame
The number of stool samples collected will be reported at the conclusion of the sample	Count of Stool Samples	8 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects will be 18 years of age or older with a clinical diagnosis of a Myasthenia Gravis.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bailey Sheldon, PhD	Contact	203-737-7095		bailey.munrosheldon@yale.edu

Overall Officials

Name	Affiliation	Role
Richard Nowak, MD, MS	Assistant Professor, Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yale-New Haven Hospital	Recruiting	New Haven	Connecticut	06510	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32388060	Background	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.
41500177	Derived

ID	Term
D020361	Paraneoplastic Syndromes, Nervous System
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms