Clinical trial · Interventional
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.
NCT07532707CI-TRIAL-00108482completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myasthenia Gravis (MG) | — | UNRESOLVED | — |
| Myasthenic Crisis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IVIG (Intravenous Immunoglobulin) | Biological | — | UNRESOLVED |
| Plasma exchange (PE) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IVIG Group
- description
- 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.
- interventionNames
- Biological: IVIG (Intravenous Immunoglobulin)
- type
- ACTIVE_COMPARATOR
- label
- PLEX Group
- description
- 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.
- interventionNames
- Procedure: Plasma exchange (PE)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (6)
- RESULTSharma 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
- RESULTRoper 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
- RESULTZain 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
- RESULTSanders 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
- RESULTRaz 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
- RESULTGajdos 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