Which drug best prevents eye muscle weakness from spreading? new study aims to find out
NCT ID NCT04182984
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at 200 adults with new-onset ocular myasthenia gravis, a condition that causes droopy eyelids and double vision. Researchers will compare different treatments, including steroids and immunosuppressants like azathioprine and tacrolimus, to see which works best and has the fewest side effects. The goal is to find the best way to keep the disease from spreading to other muscles and to improve daily life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Immunosuppressants (azathioprine, tacrolimus, mycophenolate mofetil), steroids, and symptomatic treatment (pyridostigmine bromide)
- What this could lead to
- If successful, this study could help identify which immunosuppressant works best for ocular myasthenia gravis, potentially reducing the risk of the disease spreading to other muscles.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be influenced by patient and doctor choices. The findings may not apply to all patients, and immunosuppressants carry risks like infection and organ toxicity.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2019
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with newly-onset ocular myasthenia gravis
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age \>18 years and\<75 years; 2. Clinical Diagnosis of MG with supporting evidence: Patients with ocular muscle type MG who have never received treatment meet one of the diagnoses (1) and (2)-(5): (1) The patient's symptoms involve the extraocular muscles, except for drooping eyelids and diplopia, no other clinical symptoms; (2) unequivocal clinical response to pyridostigmine; (3) positive acetylcholine receptor antibody or musk antibody; (4) decrement of more than 10% in repetitive nerve stimulations study (RNS); (5) the "trembling" of the single fiber electromyography (SFEMG) is broadened with or without blockade; 3. Willingness to sample collection, imaging study and other disease-related examinations and assessments; 4. The results of pregnancy tests for female subjects with fertility during the screening period should be negative and effective contraception was used by the patient and her spouse during the study period; 5. Patients with informed consent; 6. Predicted survival time is longer than 3 years. Exclusion Criteria: 1. History of chronic degenerative, psychiatric, or neurologic disorder other than MG that can produce weakness or fatigue; 2. Patients who may have other diseases that may lead to eyelid drooping, peripheral muscle weakness or diplopia; 3. Age ≤18 years or ≥75 years; 4. Patients who have been taking glucocorticoids or associated immunosuppressants due to other immune system diseases; 5. Patients who cannot use immunosuppressants due to other chronic diseases; 6. Patients who are unable to cooperate with follow-up and self-assessment due to severe mental illness or cognitive impairment; 7. Pregnant women, lactating women and patients with fertility plans during the trial; 8. Patients who have suffered from severe infections or malignant tumors in the last 1 month and are unable to receive immunosuppressants treatments; 9. Patients who are not willing to cooperate with repeated frequency electrical stimulation tests and chest CT examinations; 10. Patients who are not willing to participate in this study; 11. Patients who are unable to sign informed consent; 12. Predicted survival time is shorter than 3 years; 13. Patients who are not suitable to participated in the trial after researchers' assessment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tangdu Hospotal
RECRUITINGXi'an, Shaanxi, China
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