Efficacy of IVIG Versus PLEX in Myasthenic Crisis in Syria.

April 9, 2026 updated by: Damascus University

Efficacy of Intravenous Immunoglobulin Versus Plasma Exchange in Myasthenic Crisis: A Prospective Open-Label Study Based on Treatment Availability in a Tertiary Center in Syria.

This study compares the clinical effectiveness of Intravenous Immunoglobulin (IVIG) versus Plasma Exchange (PLEX) in patients experiencing a myasthenic crisis. Clinical response is evaluated 14 days post-treatment using the Quantitative Myasthenia Gravis Score (QMG). Additionally, the study aims to identify and report common precipitating factors for myasthenic attacks, such as respiratory infections or surgical stress.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This open-label prospective study evaluates patients at Al-Mouwasat and Al-Assad University Hospitals in Damascus, Syria. Participants include adult patients diagnosed with Myasthenia Gravis (MG) based on clinical evaluation and confirmed via repetitive nerve stimulation (RNS) or single-fiber electromyography (SFEMG).

Participants are assigned to two treatment groups based on the availability of medical supplies at the time of admission: the IVIG group and the PLEX group. The IVIG group receives a total dosage of 2 g/kg administered over 2 to 5 consecutive days. The PLEX group undergoes a series of up to five plasma exchange sessions.

The primary objective is to evaluate the change in the Quantitative Myasthenia Gravis Score (QMG) from baseline (Day 0) to 14 days post-treatment. The study also documents precipitating triggers for myasthenic attacks. Statistical analysis is performed using SPSS version 25.0, utilizing T-tests for continuous variables and Chi-Squared tests for categorical variables to compare the treatment methods.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syria
      • Damascus, Syria
        • Damascus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Confirmed Diagnosis: Patients with newly diagnosed or previously confirmed Myasthenia Gravis (MG) based on clinical evaluation and confirmed by electromyography (EMG).
  • Severity: Patients presenting with myasthenic crisis or severe exacerbation.
  • Age: 18 years and older.
  • Treatment Necessity: Patients requiring rapid immunomodulating therapy (either IVIG or PLEX).
  • Informed Consent: Participants or their legal guardians must be able and willing to provide written informed consent.

Exclusion Criteria:

  • Medical Contraindications: Severe renal failure (contraindication for IVIG) or hemodynamic instability (contraindication for PLEX).
  • Alternative Conditions: Presence of other neuromuscular disorders or congenital myasthenia.
  • Pregnancy: Pregnant or breastfeeding women.
  • Consent: Inability to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IVIG Group
Participants in this group receive Intravenous Immunoglobulin (IVIG) at a total therapeutic dose of 2 g/kg body weight. The dose is administered intravenously over a period of 2 to 5 consecutive days. Clinical improvement is monitored using the Quantitative Myasthenia Gravis (QMG) scale.
Biological: IVIG (Intravenous Immunoglobulin)
Patients receive Intravenous Immunoglobulin (IVIG) at a total dose of 2 g/kg body weight. The dose is divided over a period of 2 to 5 consecutive days administered intravenously
Active Comparator: PLEX Group
Participants in this group undergo therapeutic plasma exchange (PLEX) sessions. The protocol typically involves 5 sessions, performed every other day, to remove circulating antibodies. This group serves as the active comparator to evaluate the clinical response to treatment.
Procedure: Plasma exchange (PE)
Patients undergo therapeutic plasma exchange (PLEX), typically consisting of 5 sessions performed every other day., with a replacement volume of 1 to 1.5 plasma volumes per session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change from Baseline in the Quantitative Myasthenia Gravis (QMG) Score
Time Frame: Day 14 post-initiation of treatment
The QMG is a validated physician-rated instrument consisting of 13 items that assess ocular, bulbar, respiratory, and limb muscle strength. Total scores range from 0 to 39, where higher scores represent greater clinical impairment. Clinical improvement is defined as a reduction in the mean QMG score from baseline.
Day 14 post-initiation of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Anti-AChR Antibodies.
Time Frame: Day 14 post-treatment
Evaluation of the frequency of positive anti-acetylcholine receptor (AChR) antibodies among the study population to assess its correlation with the severity of the myasthenic crisis.
Day 14 post-treatment
Frequency of Myasthenic Crisis Triggers
Time Frame: Through hospital discharge, average 14 days
Identification and categorization of the most common factors leading to myasthenic crisis, such as respiratory infections or surgical stress.
Through hospital discharge, average 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Collaborators

Al Mouwasat Hospital
Al-Assad University Hospital

Investigators

  • Principal Investigator: Mohammad Shehadeh Agha, MD, PhD, Damascus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

October 15, 2023

Study Completion (Actual)

October 30, 2023

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDMS-2026-Neuro-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared with other researchers to maintain patient confidentiality and privacy, as per local institutional regulations

Study Data/Documents

  1. Study Protocol
    Information identifier: 10.17605/OSF.IO/PKTSJ
    Information comments: The study protocol is registered on the OSF platform for transparency and documentation.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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