NCT07532707

Efficacy of IVIG Versus PLEX in Myasthenic Crisis in Syria.

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Damascus University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Myasthenic Crisis
• Myasthenia Gravis (MG)

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-10-15
• Completion: 2023-10-30
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: Syria