Status:
COMPLETED
Intravenous Immunoglobulin and Plasma Exchange in Myasthenia Gravis
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Grifols Therapeutics LLC
Conditions:
Myasthenia Gravid
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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)...
Eligibility Criteria
Inclusion
- \>18 years old
- diagnosis of moderate-severe MG (defined as a Quantitative Myasthenia Gravis Score QMGS \>10.5)
- worsening weakness requiring a change in therapy judged by a neuromuscular expert
Exclusion
- Worsening weakness secondary to concurrent medications (e.g. Aminoglycosides)
- Worsening weakness secondary to infection
- Change in corticosteroid dosage in the 2 weeks prior to screening
- Other disorders causing weakness or fatigue
- Known absolute IgA deficiency (risk of anaphylactic reaction to IVIG)
- History of anaphylaxis or severe systemic response to IVIG or albumin
- Pregnancy or breastfeeding
- Active renal failure precluding volume of IVIG (risk of volume overload with IVIG) as judged by the investigators
- Clinically significant cardiac disease precluding IVIG volume as judged by the investigators
- Known hyperviscosity or hypercoaguable state (risk of stroke with IVIG)
- Known coagulopathy with bleeding
- On another current study medication or protocol within 4 weeks of screening
- Patients with known refractory status to either IVIG or PLEX
- Poorly controlled or severe hypertension (exacerbation by IVIG)
- Patient refuses treatment with either IVIG or PLEX
- Patient refuses follow-up with electrophysiological studies
- Patient unable or unwilling to give informed consent
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT01179893
Start Date
March 1 2007
End Date
July 1 2010
Last Update
August 11 2010
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G 2C4