Ocular Mysathenia Gravis Generalization

Ocular Myasthenia Gravis Clinical Trial

— MYASTEN  

Official title:

Use of Nomogram for Predictions of Ocular Mysathenia Gravis Generalization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04667650
• Other study ID #: CE_20161027_22_AGN
• Status: Completed
• Start date: January 2017
• Est. completion date: January 2020

Study information

• Verified date: December 2020
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: January 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• OMG differential diagnoses

Related Conditions & MeSH terms

• Myasthenia Gravis
• Ocular Myasthenia Gravis

Intervention

Other:
• Use of nomogram for predictions of Ocular Mysathenia Gravis generalization
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.

Locations

Country	Name	City	State
France	Antoine GUEGUEN	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 year