NCT03792659

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Mar 2016Oct 2026

Study Start

First participant enrolled

March 30, 2016

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 3, 2019

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

10.5 years

First QC Date

January 2, 2019

Last Update Submit

November 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The number of successful blood draws will be reported at the conclusion of the sample collection

    Successful Collection of Blood

    8 years

Secondary Outcomes (1)

  • The number of stool samples collected will be reported at the conclusion of the sample

    8 years

Study Arms (1)

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

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

Neurological Outpatients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

RECRUITING

Related 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.

    PMID: 32388060BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

100 cc (less than 1/2 cup) of blood

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Richard Nowak, MD, MS

    Assistant Professor, Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
8 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2019

First Posted

January 3, 2019

Study Start

March 30, 2016

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations