Myasthaenia GravisMGFAPRNCT06617741
Myasthenia Gravis Foundation of America Global MG Patient Registry
An observational study of Myasthaenia Gravis and Myasthenia, run by Myasthenia Gravis Foundation of America at 1 site in United States.
Trial summary
The goal of this observational study is to learn about the experiences of people living with Myasthenia Gravis (MG) in the United States. The main questions it aims to answer are: How and when are people with MG diagnosed? What are the most common symptoms associated with MG? What treatments are being used to treat… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthaenia Gravis, Myasthenia, Myasthenia Gravis Associated with Thymoma
- How many people
- 3,800 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2013to 19 Sep 2029
- How long will I take part?
- 15 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: Participants with access to a mobile device or desktop computer with internet connection are eligible to participate in this study
Who may be able to join
- age over 18
- positive MG diagnosis
Who cannot join
- age under 18
- misdiagnosed with MG
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
Myasthenia Gravis Foundation of America
Westborough, Massachusetts, 01581
National Director, Patient Registry, 800-541-5454, mgfa@myasthenia.org
About this study
The goal of this observational study is to learn about the experiences of people living with Myasthenia Gravis (MG) in the United States. The main questions it aims to answer are:
- How and when are people with MG diagnosed?
- What are the most common symptoms associated with MG?
- What treatments are being used to treat MG?
- What are the impacts of MG on activities of daily living, employment and quality of life?
- What are the experiences with exacerbation, hospitalization and healthcare access for people with MG? Participants will answer a survey to enroll in the study, and be invited to fill out an update survey twice a year.
Read the detailed description
This is a longitudinal, observational, patient reported registry.
- Conditions
- Myasthaenia Gravis, Myasthenia, Myasthenia Gravis Associated with Thymoma, Myasthenia Gravis Crisis, Myasthenia Gravis Exacerbations, Myasthenia Gravis Generalised
- Keywords
- myasthenia, patient registry, MGFA, Myasthenia Gravis Foundation of America, myasthenia gravis
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Those with Myasthenia Gravis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of MG
Whether the patient has a confirmed MG diagnosis.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start12 Oct 2013
- Primary completion19 Sep 2029 (estimated)
- Study completion19 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthaenia GravisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,800 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Myasthenia Gravis Foundation of America
- Sponsor type
- University, hospital or other
- Collaborators
- Alira Health
- Responsible party
- Sponsor
- Investigators
- Patient Registry PI, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617741
- Sponsor's protocol ID
- X130401004
- Acronym
- MGFAPR
- Status last verified
- Sep 2024
- First submitted
- 26 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Direct access to IPD is not widely shared. However, analysis of the data can be facilitated through collaboration with Alira Health.
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myasthenia Gravis Foundation of America Global MG Patient Registry
- ClinicalTrials.gov ID
- NCT06617741
- Acronym / sponsor ID
- MGFAPR / X130401004
- Conditions
- Myasthaenia Gravis, Myasthenia, Myasthenia Gravis Associated with Thymoma, Myasthenia Gravis Crisis, Myasthenia Gravis Exacerbations, Myasthenia Gravis Generalised
- Keywords
- myasthenia, patient registry, MGFA, Myasthenia Gravis Foundation of America, myasthenia gravis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,800 participants (estimated)
- Lead sponsor
- Myasthenia Gravis Foundation of AmericaUniversity, hospital or other
- Collaborators
- Alira Health
- Study start
- 12 Oct 2013 (actual)
- Primary completion
- 19 Sep 2029 (estimated)
- Study completion
- 19 Sep 2029 (estimated)
- First posted
- 27 Sep 2024 (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 goal of this observational study is to learn about the experiences of people living with Myasthenia Gravis (MG) in the United States. The main questions it aims to answer are:
- How and when are people with MG diagnosed?
- What are the most common symptoms associated with MG?
- What treatments are being used to treat MG?
- What are the impacts of MG on activities of daily living, employment and quality of life?
- What are the experiences with exacerbation, hospitalization and healthcare access for people with MG? Participants will answer a survey to enroll in the study, and be invited to fill out an update survey twice a year.
Detailed description
This is a longitudinal, observational, patient reported registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | –Those with Myasthenia Gravis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with access to a mobile device or desktop computer with internet connection are eligible to participate in this study
Key inclusion criteria (2 listed)
- age over 18
- positive MG diagnosis
Key exclusion criteria (2 listed)
- age under 18
- misdiagnosed with MG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis of MG
Time frame: At enrollment
Whether the patient has a confirmed MG diagnosis.
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 27 Sep 2024.
- Individual participant dataSharing planned: Undecided. Direct access to IPD is not widely shared. However, analysis of the data can be facilitated through collaboration with Alira Health.
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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.
Patient Registry PI principal investigator
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 Myasthaenia Gravis and Myasthenia, run by Myasthenia Gravis Foundation of America 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 2 inclusion and 2 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 27 Sep 2024. 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 National Director, Patient Registry (8005415454, gmvalo@myasthenia.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of MG (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.