A Pilot Trial To Assess The Feasibility And Efficacy Of SCIG In Patients With MG Exacerbation (SCIG-MG)

• Register: ClinicalTrials.gov
• Last refreshed on: 27 February 2023
• 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: 26
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02774239
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Canada

Contacts

• Name: Zaeem A Siddiqi, MD, PhD
• 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)

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]

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]

Quality of life will be assessed through the Quality of Life (QOL) score, a qualitative questionnaire. [Time Frame: Baseline - Day 42]

Proportion of participants successfully trained will be recorded indicating feasibility based on patient compliance. [Time Frame: Baseline - Week 2]

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