Last updated: August 16, 2022
Sponsor: Tang-Du Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Neuropathy
Myasthenia Gravis Generalised
Sarcopenia
Treatment
N/AClinical Study ID
NCT04182984
2019TDSNOMG
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age >18 years and<75 years;
- Clinical Diagnosis of MG with supporting evidence: Patients with ocular muscle type MG who have never received treatment meet one of thediagnoses (1) and (2)-(5): (1) The patient's symptoms involve the extraocular muscles,except for drooping eyelids and diplopia, no other clinical symptoms; (2) unequivocalclinical response to pyridostigmine; (3) positive acetylcholine receptor antibody ormusk antibody; (4) decrement of more than 10% in repetitive nerve stimulations study (RNS); (5) the "trembling" of the single fiber electromyography (SFEMG) is broadenedwith or without blockade;
- Willingness to sample collection, imaging study and other disease-related examinationsand assessments;
- The results of pregnancy tests for female subjects with fertility during the screeningperiod should be negative and effective contraception was used by the patient and herspouse during the study period;
- Patients with informed consent;
- Predicted survival time is longer than 3 years.
Exclusion
Exclusion Criteria:
- History of chronic degenerative, psychiatric, or neurologic disorder other than MGthat can produce weakness or fatigue;
- Patients who may have other diseases that may lead to eyelid drooping, peripheralmuscle weakness or diplopia;
- Age ≤18 years or ≥75 years;
- Patients who have been taking glucocorticoids or associated immunosuppressants due toother immune system diseases;
- Patients who cannot use immunosuppressants due to other chronic diseases;
- Patients who are unable to cooperate with follow-up and self-assessment due to severemental illness or cognitive impairment;
- Pregnant women, lactating women and patients with fertility plans during the trial;
- Patients who have suffered from severe infections or malignant tumors in the last 1month and are unable to receive immunosuppressants treatments;
- Patients who are not willing to cooperate with repeated frequency electricalstimulation tests and chest CT examinations;
- Patients who are not willing to participate in this study;
- Patients who are unable to sign informed consent;
- Predicted survival time is shorter than 3 years;
- Patients who are not suitable to participated in the trial after researchers'assessment.
Study Design
Total Participants: 200
Study Start date:
November 04, 2019
Estimated Completion Date:
November 04, 2024
Study Description
Connect with a study center
Tangdu Hospotal
Xi'an, Shaanxi
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.