A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia Gravis

Astellas

Status and phase: Completed; Phase 3

Conditions: Myasthenia Gravis

Treatments: Drug: Tacrolimus capsule; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01325571

F506-CL-0611

Details and patient eligibility

About

To evaluate the efficacy and safety of tacrolimus capsules in patients with myasthenia gravis who are inadequately treated by glucocorticoid.

Enrollment: 83 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosed as myasthenia gravis (MG) by clinical diagnosis
• QMG scores ≥7 at the time of enrollment
• basic treatment drugs are mainly glucocorticoids, and the efficacy of glucocorticoid therapy was not sufficient

Exclusion criteria

• receiving blood purification therapy or immunoglobulin therapy within 8 weeks before the study
• QMG swallowing function score ≥ 2 points or QMG vital capacity = 3
• abnormal hepatic functions
• uncontrolled diabetes patients
• hyperkalemia patients
• immuno-inhibitors are forbidden due to malignancy, history of malignancy or history of HIV infection
• patients who are allergic to Tacrolimus or macrolide antibiotics
• receiving other immuno-inhibitors within 12 weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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83 participants in 2 patient groups, including a placebo group

tacrolimus group

Experimental group

Treatment:

Drug: Tacrolimus capsule

placebo group

Placebo Comparator group

Treatment:

Drug: Placebo