Clinical trial for dose dependent initial worsening of IVMP in gMG

JRCT ID: jRCTs061240006

Registered date:01/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Myasthenia gravis
• Date of first enrollment: 22/05/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): One to four cycles of 3-day course of intravenous methylprednisolone which initial dose is 250 mg per day or 1000 mg per day

Outcome(s)

• Primary Outcome: Number of patients with increasing MG-ADL scale score 2 or more from initiation of intravenous methylprednisolone therapy (IVMP)

Secondary Outcome

1) Initial day of increasing MG-ADL scale score 2 or more from initiation of IVMP
2) Duration of increasing MG-ADL scale score 2 or more from initiation of IVMP
3) Number of patients with decreasing by at least 2 points of MG-ADL scale score between registration and discharge
4) Score difference of MG-ADL scale between admission and discharge
5) Score difference of QMG scale between admission and discharge
6) Score difference of MG composite scale between admission and discharge
7) Score difference of MG-QOL 15r-J scale between admission and discharge
8) Postintervention status at discharge
9) Number of cycles of IVMP from registration to discharge
10) Interval days of each IVMP cycle
11) Score difference of MG-ADL scale at 1st cycle (at admission, at appearing initial worsening, at peak of initial worsening, at the end of 1st cycle)
12) Score difference of MG composite scale at 1st cycle (at admission, at appearing initial worsening, at peak of initial worsening, at the end of 1st cycle)
13) Change of marker for elucidation of pathology of initial worsening
14) Dose escalation of next cycle of IVMP 250mg group, or dose de-escalation of next cycle of IVMP 1000mg group
15) Dose of IVMP and Postintervention status at last cycle
16) Presence or absence of myasthenic crisis, corresponding to the situation of myasthenic crisis, or the situation of 3-day or more long lying on bed
17) Total amount of IVMP between admission and discharge and Postintervention status at discharge

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. MGFA II or III
2. Worsening or unchanged clinical myasthenic symptoms and expecting improvement of clinical symptoms by fast-acting treatment
3. Obtaining written informed consent from the participant

Exclude criteria

1. Having malignancy which need to have treatment
2. Inappropriating using IVMP for affecting symptoms of comorbidities for example, poorly controlled diabetes, psychiatric disorders
3. Expecting improve clinical motor symptoms from comorbidities by using IVMP for example, chronic inflammatory demyelinating polyneuropathy
4. Inappropriating to participate the trial for example, neurocognitive disorder
5. Medical doctors being involved in the trial, employees by medical facility, and the relative family of the doctors
6. Under 18 years of age
7. Being Pregnant or lactating
8. Not being hospitalized
9. Having infection before using IVMP

Related Information

• Primary Sponsor: Sugimoto Takamichi