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Which drug best prevents eye muscle weakness from spreading? new study aims to find out

NCT ID NCT04182984

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2019

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Tangdu Hospotal

    RECRUITING

    Xi'an, Shaanxi, China

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