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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02774239
Date of registration: 20/04/2015
Prospective Registration: No
Primary sponsor: University of Alberta
Public title: A Pilot Trial To Assess The Feasibility And Efficacy Of SCIG In Patients With MG Exacerbation (SCIG-MG) SCIG-MG
Scientific title: A Pilot Trial To Assess The Feasibility And Efficacy Of Subcutaneous Immunoglobulin In Patients With Myasthenia Gravis Exacerbation
Date of first enrolment: October 2014
Target sample size: 30
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02774239
Study type:  Interventional
Study design:  Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Canada
Contacts
Name:     Derrick G Blackmore, B.Sc
Address: 
Telephone: 780-407-3367
Email: dblackmo@ualberta.ca
Affiliation: 
Name:     Zaeem A Siddiqi, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  University of Alberta
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients between18 to 80 years of age, diagnosed with MG (see below) who have
worsening myasthenic symptoms - (defined as increasing diplopia, ptosis, dysarthria,
dysphagia, difficulty chewing, or limb weakness severe enough to warrant
immunoglobulin therapy.

- MG diagnosis will be based upon the clinical evaluation by a neuromuscular expert and
meeting any two of the following supportive criteria:

1. Abnormal Tensilon test

2. Abnormal repetitive nerve stimulation studies

3. Abnormal single fiber electromyography (EMG)

4. Increased serum acetylcholine receptor or anti-MuSK antibodies

5. Prior response to immunotherapy

Exclusion Criteria:

1. Respiratory distress requiring ICU admission or a vital capacity <1 L

2. Severe swallowing difficulties with a high risk of aspiration

3. Change in corticosteroid dosage in the 4 weeks prior to screening

4. Known immunoglobulin A (IgA) deficiency

5. Pregnant or breast feeding women

6. Active renal or hepatic insufficiency, clinically significant cardiac disease

7. Patients with worsening weakness associated with an infectious process

8. Previous lack of responsiveness to IVIG

9. History of previous MG crises



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Myasthenia Gravis
Intervention(s)
Drug: Human normal immunoglobulin G (IgG)
Primary Outcome(s)
Change in Quantitative Myasthenia Gravis Score (QMGS) from baseline to day 42 after treatment. [Time Frame: Baseline - Day 42]
Secondary Outcome(s)
Adverse events related to SCIG infusions will be recorded if/when they occur. [Time Frame: Baseline - Day 42]
Change in Manual Muscle Testing (MMT) score from baseline to day 42 after treatment. [Time Frame: Baseline - Day 42]
Myasthenia Gravis (MG) Composite scores will be used to evaluate disease severity through a number of functional assessments, including muscle strength and ability to complete activities of daily living. [Time Frame: Baseline - Day 42]
Patient satisfaction with the treatment modality will be assessed using a questionnaire. [Time Frame: Day 42]
Proportion of participants completing will be recorded indicating feasibility based on patient compliance. [Time Frame: Baseline - Day 42]
Proportion of participants successfully trained will be recorded indicating feasibility based on patient compliance. [Time Frame: Baseline - Week 2]
Quality of life will be assessed through the Quality of Life (QOL) score, a qualitative questionnaire. [Time Frame: Baseline - Day 42]
Serious Adverse Events related to SCIG infusions will be recorded if/when they occur. [Time Frame: Baseline - Day 42]
Secondary ID(s)
ZS2013-01
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
CSL Behring
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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