Skip to main content
OpenTrials
Completed

NCT Number: NCT01325571

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myasthenia Gravis Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus capsule

Drug

oral

Other names: Prograf, FK506

Placebo

Drug

oral

Primary outcomes

  1. Change from baseline in quantitative myasthenia gravis (QMG) score for disease severity

    Time frame: Baseline and at 24 weeks

  2. Change from baseline in QMG score for disease severity

    Time frame: Baseline and at 4 weeks

  3. Change from baseline in QMG score for disease severity

    Time frame: Baseline and at 8 weeks

  4. Change from baseline in QMG score for disease severity

    Time frame: Baseline and at 12 weeks

  5. Change from baseline in QMG score for disease severity

    Time frame: Baseline and at 16 weeks

  6. Change from baseline in QMG score for disease severity

    Time frame: Baseline and at 20 weeks

Secondary outcomes

  1. Changes in Osserman classification

    Time frame: Baseline and at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

  2. Changes in myasthenia gravis activity of daily living scale

    Time frame: Baseline and at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma China, Inc.

Registry information

Official study title

A Randomized, Double-blinded, Placebo-controlled, and Multi-centered Clinical Trial Evaluating the Efficacy and Safety of Tacrolimus Capsule in Myasthenia Gravis That Was Insufficiently Treated by Glucocorticoid Therapy

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 30, 2011
Registry last updated
Mar 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.