NCT01325571

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2011

Typical duration for phase_3

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 30, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

March 9, 2016

Status Verified

March 1, 2016

Enrollment Period

3.2 years

First QC Date

March 16, 2011

Last Update Submit

March 8, 2016

Conditions

Myasthenia Gravis

Keywords

prografimmunosuppressant

Outcome Measures

Primary Outcomes (6)

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

    Baseline and at 24 weeks

  • Change from baseline in QMG score for disease severity

    Baseline and at 4 weeks

  • Change from baseline in QMG score for disease severity

    Baseline and at 8 weeks

  • Change from baseline in QMG score for disease severity

    Baseline and at 12 weeks

  • Change from baseline in QMG score for disease severity

    Baseline and at 16 weeks

  • Change from baseline in QMG score for disease severity

    Baseline and at 20 weeks

Secondary Outcomes (2)

  • Changes in Osserman classification

    Baseline and at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

  • Changes in myasthenia gravis activity of daily living scale

    Baseline and at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

Study Arms (2)

tacrolimus group

EXPERIMENTAL
Drug: Tacrolimus capsule

placebo group

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Tacrolimus capsuleDRUG

oral

Also known as: Prograf, FK506
tacrolimus group
PlaceboDRUG

oral

placebo group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Beijing, China

Location

Unknown Facility

Guangdong, China

Location

Unknown Facility

Jiangsu, China

Location

Unknown Facility

Jilin, China

Location

Unknown Facility

Shandong, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Sichuan, China

Location

Unknown Facility

Wuhan, China

Location

Unknown Facility

Zhejiang, China

Location

Related Publications (1)

  • Zhou L, Liu W, Li W, Li H, Zhang X, Shang H, Zhang X, Bu B, Deng H, Fang Q, Li J, Zhang H, Song Z, Ou C, Yan C, Liu T, Zhou H, Bao J, Lu J, Shi H, Zhao C. Tacrolimus in the treatment of myasthenia gravis in patients with an inadequate response to glucocorticoid therapy: randomized, double-blind, placebo-controlled study conducted in China. Ther Adv Neurol Disord. 2017 Sep;10(9):315-325. doi: 10.1177/1756285617721092. Epub 2017 Jul 26.

    PMID: 28861121DERIVED

Related Links

MeSH Terms

Conditions

Myasthenia Gravis

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Use Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 30, 2011

Study Start

March 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

March 9, 2016

Record last verified: 2016-03

Locations

CN(9)