Myasthenia GravisNCT03792659
The EXPLORE MG Registry for Myasthenia Gravis
An observational study of Myasthenia Gravis, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- Blood Sample Draw
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2016to 30 Oct 2026
- How long will I take part?
- 8 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be 18 years of age or older with a clinical diagnosis of a Myasthenia Gravis.
Who may be able to join
- 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.
Who cannot join
- Failure to meet the Inclusion Criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale-New Haven Hospital
New Haven, Connecticut, 06510
Bailey Munro Sheldon, PhD, 203-737-7095, bailey.munrosheldon@yale.edu
Richard Nowak, MD, MS
About this study
Official title: 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.
Read the 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.
- Conditions
- Myasthenia Gravis
- Being tested
- Blood Sample Draw
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Sample DrawOther
Approximately 100 cc (less than 1/2 cup) of blood will be drawn from both groups.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood Sample Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of successful blood draws will be reported at the conclusion of the sample collection
Successful Collection of Blood
Measured: 8 years
Secondary outcomes (1)
The number of stool samples collected will be reported at the conclusion of the sample
Count of Stool Samples
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start30 Mar 2016
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 800 participants (estimated)
- Target duration
- 8 Years
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Nowak, MD, MS, Principal investigator, Assistant Professor, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792659
- Sponsor's protocol ID
- 1602017284
- Status last verified
- Nov 2025
- First submitted
- 2 Jan 2019
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32388060McLaren N, Gutierrez AZ, Joo D, Roy B, Park M, Nowak RJ. Variations in clinical features and disease burden of myasthenia gravis between racial and ethnic groups: A retrospective cohort study of two national databases. J Neurol Sci. 2026 Feb 15;481:125740. doi: 10.1016/j.jns.2026.125740. Epub 2026 Jan 5.
PubMed 41500177
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Outcomes and Characteristics of Myasthenia Gravis: The EXPLORE MG Registry
- ClinicalTrials.gov ID
- NCT03792659
- Acronym / sponsor ID
- 1602017284
- Conditions
- Myasthenia Gravis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 30 Mar 2016 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 3 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 8 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurological Outpatients | – | Other: Blood Sample DrawParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be 18 years of age or older with a clinical diagnosis of a Myasthenia Gravis.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Failure to meet the Inclusion Criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Sample DrawApproximately 100 cc (less than 1/2 cup) of blood will be drawn from both groups. | Other | Neurological Outpatients |
Primary outcome
The number of successful blood draws will be reported at the conclusion of the sample collection
Time frame: 8 years
Successful Collection of Blood
1 secondary outcome
The number of stool samples collected will be reported at the conclusion of the sample
Time frame: 8 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Background: PubMed 32388060Anil 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.
- Derived from this study: PubMed 41500177McLaren N, Gutierrez AZ, Joo D, Roy B, Park M, Nowak RJ. Variations in clinical features and disease burden of myasthenia gravis between racial and ethnic groups: A retrospective cohort study of two national databases. J Neurol Sci. 2026 Feb 15;481:125740. doi: 10.1016/j.jns.2026.125740. Epub 2026 Jan 5.
- Individual participant dataSharing planned: No
Related trials for Myasthenia Gravis
RecruitingPhase 2/3
A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
Generalized Myasthenia Gravis
Not yet recruitingEarly Phase 1
A Clinical Study to Evaluate the Safety and Efficacy of GT802 Injection in the Treatment of Refractory Generalized Myasthenia Gravis
Generalized Myasthenia Gravis (gMG)
Recruiting
Holistic Assessment and Remote Digital MONitoring of mYasthenia Gravis Via MyoSense 360
Myasthenia Gravis, Generalized
RecruitingPhase 3
A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
Myasthenia Gravis
RecruitingPhase 2
ADAPT Forward 2 - ISA2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis
AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis (MG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard Nowak, MD, MS principal investigator
Assistant Professor, Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bailey Sheldon, PhD (203-737-7095, bailey.munrosheldon@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of successful blood draws will be reported at the conclusion of the sample collection (time frame: 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03792659, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.