Efficacy and safety of methylprednisolone pulse therapy for ocular myasthenia gravis: a pilot study

Not Applicable

Recruiting

• Conditions: ocular myasthenia gravis; ocular myasthenia gravis, steroid pulse, methylprednisolone

• Registration Number: JPRN-jRCTs051200137
• Lead Sponsor: Koh Jinsoo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

(1) Diagnosed of OMG without thymoma with any of the symptoms of ocular motility disorder, ptosis, or facial muscle weakness showing easy fatigue
(2) One or more positive findings of either A or B:
A. Pathogenic autoantibodies (1 or 2)
1 Anti-acetylcholine receptor (AChR) antibody
2 Anti-muscle-specific receptor tyrosine kinase (MuSK) antibody
B. Neuromuscular junction disorders (one or more of the following)
1 Eyelid fatigue test
2 Ice pack test
3 Edrophonium test
4 Repeated stimulation test
5 Increased jitter in single-fiber EMG
(3) An ocular MG-ADL scale 1 or higher, and ocular symptoms that interfere with daily activities
(4) Treating the maximum dose of AChE-I or difficulty increasing the dose of AChE-I due to adverse events
(5) Aged 20 years or older
(6) Capable of providing informed consent and complying with study procedures

Exclusion Criteria

(1) Disease duration 10 years or more after onset
(2) Treatment with systemic corticosteroids, immunosuppressive drugs, immunoglobulins or plasmapheresis within 90 days of enrollment.
(3) Patients with thymoma (post-resection patients are acceptable)
(4) Poorly controlled diabetes (HbA1c 8.0% or more)
(5) Poorly controlled glaucoma
(6) Poorly controlled hypertension (systolic blood pressure 180 mmHg or higher, or diastolic blood pressure 100 mmHg or higher)
(7) prior steroid intolerance
(8) Obesity (BMI over 40 kg/m2)
(9) A history of osteoporotic fracture
(10) HBs antigen positive or HBV-DNA amount detection sensitivity or higher, or HCV antibody positive
(11) Tuberculosis infection within 2 years, or interferon gamma release assay (T-spot. TB or QFT) positive
(12) Active thyroid disease, liver or renal failure, poorly controlled cardiac or blood disease, active peptic ulcer or infection, or any other illness that would make it unsafe for the patient to participate in the trial
(13) Pregnant or lactating
(14) Receipt of another study within 30 days prior to enrollment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ocular MG-ADL change 4 weeks after the start of IVMP

Secondary Outcome Measures

Name	Time	Method
MM achievement rate at 4 to 16 weeks<br>Ocular-QMG scores at baseline and at 4 and 8 weeks, 12 weeks, 16 weeks<br>Ocular MG-ADL scale at baseline and at 4 and 8 weeks, 12 weeks, 16 weeks<br>MG-QOL15 at baseline and at 4 and 16 weeks<br>Adverse event