Precision Diagnosis and Prospective Cohort Study for Myasthenia Gravis: Multicenter Analysis in China

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Fudan University

Status

Enrolling

Conditions

Myasthenia Gravis

Treatments

Device: pheripheral biomarkers

Study type

Observational

Funder types

Other

Identifiers

NCT04535843
2020-999

Details and patient eligibility

About

The present study is a prospective cohort study aiming to improve the clinical capacity in the diagnosis and natural history of Chinese patients with myasthenia gravis (MG). 300 MG patients are planned to recruit, document and prospectively follow up. Management of screening test and cohort manifestation are studied.

Enrollment

300 estimated patients

Sex

All

Ages

Under 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

fluctuating muscle weakness and fatigability, along with one of the below:

  • more than 10% amplitude decrement in low frequency repetitive nerve stimulation,less than 10% amplitude increment in high frequency repetitive nerve stimulation;
  • anti-AChR or MuSK antibody positivity;
  • positive to the neostigmine test;
  • understanding and assigning the informed consent form, and having a good compliance with the follow up.

Exclusion criteria

  • excluding the possible diagnosis of Lambert-Eaton syndrome, congenital myasthenia syndrome,botulism injection, chronic progressive extraocular ophthalmoplegia, etc;
  • participating other clinical trials;
  • poor compliance to the follow up.

Trial design

300 participants in 1 patient group

myasthenia gravis
Description:
300 MG patients are anticipated for precision diagnosis and disease monitoring.
Treatment:
Device: pheripheral biomarkers

Trial contacts and locations

4

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Central trial contact

Chongbo Zhao, MD

Data sourced from clinicaltrials.gov

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