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Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis

NCT00515450 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2010-07-30

No results posted yet for this study

Summary

This randomized controlled, multi-center study will carry out to assess the efficacy of GB-0998 compared to plasmapheresis in the treatment of the generalized Myasthenia Gravis based on the changes in Quantitative Myasthenia Gravis score (QMG score) as primary endpoint, and in addition, to assess the safety of GB-0998

Conditions

Interventions

BIOLOGICAL

GB-0998 (Intravenous immunoglobulin)

PROCEDURE

Plasmapheresis

Sponsors & Collaborators

  • Benesis Corporation

    lead INDUSTRY

Principal Investigators

  • Masaharu Takamori, Director · Neurological Center Kanazawa-Nishi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2010-05-31
Completion
2010-06-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00515450 on ClinicalTrials.gov