Ocular Myasthenia GravisMYASTENNCT04667650
Ocular Mysathenia Gravis Generalization
An observational study of Ocular Myasthenia Gravis, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Secondary ocular myasthenia gravis (OMG) generalization represents a pejorative evolution and no validated generalization prevention strategy exists. The aim of this observational study was to determine the percentage of patients with OMG generalization and identify factors predictive of that pejorative evolution. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ocular Myasthenia Gravis
- What is being tested?
- Use of nomogram for predictions of Ocular Mysathenia Gravis generalization
- How many people
- 151 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with OMG diagnosis and its generalization who consulted between January 1990 to January 2017 at Fondation Hospital Adolphe de Rothschild and registered in the database
Who may be able to join
- Patients with OMG diagnosis and its generalization who consulted between January 1990 to January 2017 at Fondation Hospital Adolphe de Rothschild and registered in the database
Who cannot join
- OMG differential diagnoses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Nomogram for Predictions of Ocular Mysathenia Gravis Generalization
Secondary ocular myasthenia gravis (OMG) generalization represents a pejorative evolution and no validated generalization prevention strategy exists. The aim of this observational study was to determine the percentage of patients with OMG generalization and identify factors predictive of that pejorative evolution. Data from patients with OMG registered in the Fondation Hospital A. de Rothschild database between January 1990 and January 2017 were collected. Among the 183 patients registered in this database, 151 patients with available informations were analyzed.
- Conditions
- Ocular Myasthenia Gravis
- Being tested
- Use of nomogram for predictions of Ocular Mysathenia Gravis generalization
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of nomogram for predictions of Ocular Mysathenia Gravis generalizationOther
The outcome measure was time to Myasthenia gravis generalization. The explanatory variables were age at onset, sex, first-year anti-acetylcholinereceptor antibody positivity, repetiting nerve stimulation showing electromyogram decrement and steroid use. Kaplan-Meier survival estimations, descriptive and multivariate Cox model analyses were computed. A nomogram combining explanatory vraiables was used to establish a score to predict the probability of OMG generalization.
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to myasthenia gravis generalization
Kaplan-meier survival estimations, descriptive and multivariate Cox model analyses were computed (age at onset, first year anti-acetylcholine receptor antibody positivity, electromyogram decrement, steroid use).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study startJan 2017
- Primary completionJan 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Myasthenia 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
- Retrospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Amélie Yavchitz, Fondation Ophtalmologique Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667650
- Sponsor's protocol ID
- CE_20161027_22_AGN
- Acronym
- MYASTEN
- Status last verified
- Dec 2020
- First submitted
- 8 Dec 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Nomogram for Predictions of Ocular Mysathenia Gravis Generalization
- ClinicalTrials.gov ID
- NCT04667650
- Acronym / sponsor ID
- MYASTEN / CE_20161027_22_AGN
- Conditions
- Ocular Myasthenia Gravis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 16 Dec 2020 (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.
Secondary ocular myasthenia gravis (OMG) generalization represents a pejorative evolution and no validated generalization prevention strategy exists. The aim of this observational study was to determine the percentage of patients with OMG generalization and identify factors predictive of that pejorative evolution. Data from patients with OMG registered in the Fondation Hospital A. de Rothschild database between January 1990 and January 2017 were collected. Among the 183 patients registered in this database, 151 patients with available informations were analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with OMG diagnosis and its generalization who consulted between January 1990 to January 2017 at Fondation Hospital Adolphe de Rothschild and registered in the database
Key inclusion criteria (1 listed)
- Patients with OMG diagnosis and its generalization who consulted between January 1990 to January 2017 at Fondation Hospital Adolphe de Rothschild and registered in the database
Key exclusion criteria (1 listed)
- OMG differential diagnoses
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 |
|---|---|---|
| Use of nomogram for predictions of Ocular Mysathenia Gravis generalizationThe outcome measure was time to Myasthenia gravis generalization. The explanatory variables were age at onset, sex, first-year anti-acetylcholinereceptor antibody positivity, repetiting nerve stimulation showing electromyogram decrement and steroid use. Kaplan-Meier survival estimations, descriptive and multivariate Cox model analyses were computed. A nomogram combining explanatory vraiables was used to establish a score to predict the probability of OMG generalization. | Other | – |
Primary outcome
Time to myasthenia gravis generalization
Time frame: 1 year
Kaplan-meier survival estimations, descriptive and multivariate Cox model analyses were computed (age at onset, first year anti-acetylcholine receptor antibody positivity, electromyogram decrement, steroid use).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Ocular Myasthenia Gravis, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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: finished, as of the sponsor's last update on 16 Dec 2020. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to myasthenia gravis generalization (time frame: 1 year). 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 16 Dec 2020.