Efficacy of IVIG Versus PLEX in Myasthenic Crisis in Syria.

NCT07532707 | Completed

• 1 other identifier: UDMS-2026-Neuro-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myasthenic Crisis; Myasthenia Gravis (MG)

Keywords

Myasthenia Gravis; Myasthenic Crisis; Intravenous Immunoglobulin (IVIG); Plasma Exchange (PLEX); Quantitative Myasthenia Gravis Score (MGQS); Syria

Outcome Measures

Primary Outcomes (1)

• Mean Change from Baseline in the Quantitative Myasthenia Gravis (QMG) Score

  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 Outcomes (2)

• Presence of Anti-AChR Antibodies.

  Day 14 post-treatment

• Frequency of Myasthenic Crisis Triggers

  Through hospital discharge, average 14 days

Study Arms (2)

IVIG Group

EXPERIMENTAL

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)

PLEX Group

ACTIVE COMPARATOR

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)

Interventions

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

IVIG Group

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.

PLEX Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead
• Al Mouwasat Hospital: collaborator
• Al-Assad University Hospital: collaborator

Study Sites (1)

Damascus University

Damascus, Syria

Location

Related Publications (6)

• Sharma S, Lal V, Prabhakar S, Agarwal R. Clinical profile and outcome of myasthenic crisis in a tertiary care hospital: A prospective study. Ann Indian Acad Neurol. 2013 Apr;16(2):203-7. doi: 10.4103/0972-2327.112466.

  PMID: 23956564 RESULT

• Roper J, Fleming ME, Long B, Koyfman A. Myasthenia Gravis and Crisis: Evaluation and Management in the Emergency Department. J Emerg Med. 2017 Dec;53(6):843-853. doi: 10.1016/j.jemermed.2017.06.009. Epub 2017 Sep 12.

  PMID: 28916122 RESULT

• Zain A, Akram MS, Ashfaq F, Ans A, Ans HH. Comparative Analysis of Intravenous Immunoglobulins (IVIg) vs Plasmapheresis (PLEX) in the Management of Myasthenic Crisis. Cureus. 2024 Sep 7;16(9):e68895. doi: 10.7759/cureus.68895. eCollection 2024 Sep.

  PMID: 39376877 RESULT

• Sanders DB, Wolfe GI, Benatar M, Evoli A, Gilhus NE, Illa I, Kuntz N, Massey JM, Melms A, Murai H, Nicolle M, Palace J, Richman DP, Verschuuren J, Narayanaswami P. International consensus guidance for management of myasthenia gravis: Executive summary. Neurology. 2016 Jul 26;87(4):419-25. doi: 10.1212/WNL.0000000000002790. Epub 2016 Jun 29.

  PMID: 27358333 RESULT

• Raz N, Dotan S, Benoliel T, Chokron S, Ben-Hur T, Levin N. Sustained motion perception deficit following optic neuritis: Behavioral and cortical evidence. Neurology. 2011 Jun 14;76(24):2103-11. doi: 10.1212/WNL.0b013e31821f4602.

  PMID: 21670440 RESULT

• Gajdos P, Chevret S, Toyka KV. Intravenous immunoglobulin for myasthenia gravis. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD002277. doi: 10.1002/14651858.CD002277.pub4.

  PMID: 23235588 RESULT

Related Links

• Study Protocol and Statistical Analysis Plan on OSF

MeSH Terms

Conditions

Myasthenia Gravis

Interventions

Immunoglobulins, Intravenous; Plasma Exchange

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Mohammad Shehadeh Agha, MD, PhD

  Damascus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: None (open Lable)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, non-randomized, parallel-group study comparing the efficacy of IVIG versus Plasma Exchange in patients with Myasthenic Crisis.

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 16, 2026
• Study Start: September 1, 2022
• Primary Completion: October 15, 2023
• Study Completion: October 30, 2023
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)