Viewing Study NCT01179893


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Study NCT ID: NCT01179893
Status: COMPLETED
Last Update Posted: 2010-08-11
First Post: 2010-08-09
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Intravenous Immunoglobulin and Plasma Exchange in Myasthenia Gravis
Sponsor: University Health Network, Toronto
Organization:

Study Overview

Official Title: A Randomized Trial of Plasma Exchange vs. IVIG in the Treatment of Myasthenia Gravis
Status: COMPLETED
Status Verified Date: 2010-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: