Intravenous Immunoglobulin and Plasma Exchange in Myasthenia Gravis
Information source: University Health Network, Toronto
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myasthenia Gravid
Intervention: IVIG (Biological); PLEX (Procedure)
Phase: Phase 4
Status: Completed
Sponsored by: University Health Network, Toronto Official(s) and/or principal investigator(s):
Vera Bril, BSc, MD, FRCPC, Principal Investigator, Affiliation: University Health Network, Toronto
David Barth, MD, Principal Investigator, Affiliation: University Heatlh Network
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.
Clinical Details
Official title: A Randomized Trial of Plasma Exchange vs. IVIG in the Treatment of Myasthenia Gravis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in Quantitative Myasthenia Gravis Score (QMGS) from baseline to day 14 after treatment
Secondary outcome: QMGS Score change at days 21 and 28 from start of treatment.Post intervention status Single fiber electromyography: jitter, percent abnormal pair, percent blocking Repetitive Nerve stimulation studies Acetylcholine Receptor Antibody titers AntiMUSK antibody Need for ICU admission, ventilation, intubation Hospitalization Need for additional myasthenic treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- >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 Criteria:
- 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
Locations and Contacts
University Health Network, Toronto, Ontario M5G 2C4, Canada
Additional Information
Related publications: Zinman L, Ng E, Bril V. IV immunoglobulin in patients with myasthenia gravis: a randomized controlled trial. Neurology. 2007 Mar 13;68(11):837-41.
Starting date: March 2007
Last updated: August 9, 2010
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