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Intravenous Immunoglobulin and Plasma Exchange in Myasthenia Gravis

NCT01179893 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2010-08-11

No results posted yet for this study

Summary

Immunomodulation is effective in treating patients with myasthenia gravis (MG), but prior studies have not adequately defined if plasma exchange (PLEX) in superior to intravenous immunoglobulin (IVIG) in the treatment of myasthenia gravis. This study aimed to determine if PLEX was superior to IVIG in the treatment of patients with myasthenia gravis.

Patients with MG requiring immunomodulation are randomized to IVIG or PLEX and treated with a full course of immunomodulation. The quantitative myasthenia gravis score (QMGS) will be evaluated as the primary efficacy parameter at day 14 to determine if PLEX is superior to IVIG.

Conditions

  • Myasthenia Gravid

Interventions

BIOLOGICAL

IVIG

Intravenous immunoglobulin

PROCEDURE

PLEX

Plasma exchange: removal of pathogenic antibodies and constituents and replacement with albumin.

Sponsors & Collaborators

  • Grifols Therapeutics LLC

    collaborator INDUSTRY

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Vera Bril, BSc, MD, FRCPC · University Health Network, Toronto

  • David Barth, MD · University Heatlh Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Canada

Study Locations

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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 NCT01179893 on ClinicalTrials.gov