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Completed

NCT Number: NCT07532707

Efficacy of IVIG Versus PLEX in Myasthenic Crisis 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.

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Key information

Conditions

Myasthenic Crisis Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Myasthenia Gravis Myasthenia Gravis (MG) Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus University

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IVIG (Intravenous Immunoglobulin)

Biological

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

Plasma exchange (PE)

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Collaborators

  • Al Mouwasat Hospital
  • Al-Assad University Hospital

Registry information

Official study title

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.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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