A Comparison of Daily and Alternate-Day Prednisolone Therapy in the Treatment of Myasthenia Gravis: A pilot study
- Conditions
- A Comparison of Daily and Alternate-Day Prednisolone Therapy in the Treatment of Myasthenia GravisMyasthenia gravis
- Registration Number
- TCTR20240515008
- Lead Sponsor
- Siriraj Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 60
Age 18-80 years old
Patients with diagnosis of myasthenia gravis at Siriraj Hospital, Mahidol University, Bangkok, Thailand
Patients who have indication for corticosteroid Generalized MG or Ocular MG that not in minimal manifestation state (MMS) after taken Pyridostigmine more than 360 mg/d
Patients who presented with myasthenic crisis
Patients who have contraindication to corticosteroids : uncontrolled infection, uncontrolled diabetes mellitus (HbA1C 9.0), severe osteoporosis (the threshold of bone density value < -2.5 SD of T-score)
Patients who are currently receiving corticosteroids treatment
Body weight more than 100 Kg
Patients who are Anti-MuSK Ab positive
Patients who are corticosteroids, Azathioprine or Mycophenolate mofetil allergy
Patients who are currently pregnancy or lactation
Patients who are terminally ill
Patients who have active infection including TB, HBV, HCV and HIV
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare side effects of alternate-day prednisolone therapy and daily prednisolone therapy for myasthenia gravis 6 months body weight, infection, number of absolute lymphocyte count, fasting blood sugar (FBS), hemoglobin A1c ( HbA1C) and lipid profile; myasthenic crisis, steroid induced-exacerbation
- Secondary Outcome Measures
Name Time Method To evaluate efficacy of alternate-day prednisolone therapy compared to daily therapy for myasthenia gravis treatment by 6 months days of MMS within the first 6 months after treatment, time to MMS changes in MGFA score differentiation, QOL score, and MG composite scale