Myasthenic CrisisNCT07532707
Efficacy of IVIG Versus PLEX in Myasthenic Crisis in Syria.
A study testing IVIG (Intravenous Immunoglobulin) and Plasma exchange (PE) in people with Myasthenic Crisis and Myasthenia Gravis (MG), run by Damascus University at 1 site in Syria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenic Crisis, Myasthenia Gravis (MG)
- What is being tested?
- IVIG (Intravenous Immunoglobulin) and Plasma exchange (PE)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSyria
- Study dates
- 1 Sep 2022to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read the 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)
- Being tested
- IVIG (Intravenous Immunoglobulin), Plasma exchange (PE)
- Keywords
- Myasthenia Gravis, Myasthenic Crisis, Intravenous Immunoglobulin (IVIG), Plasma Exchange (PLEX), Quantitative Myasthenia Gravis Score (MGQS), Syria
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Plasma exchange (PE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 14 post-initiation of treatment
Secondary outcomes (2)
Presence of Anti-AChR Antibodies.
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.
Measured: Day 14 post-treatment
Frequency of Myasthenic Crisis Triggers
Identification and categorization of the most common factors leading to myasthenic crisis, such as respiratory infections or surgical stress.
Measured: Through hospital discharge, average 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Sep 2022
- Primary completion15 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Myasthenic CrisisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, non-randomized, parallel-group study comparing the efficacy of IVIG versus Plasma Exchange in patients with Myasthenic Crisis.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Collaborators
- Al Mouwasat Hospital, Al-Assad University Hospital
- Responsible party
- Sponsor
- Investigators
- Mohammad Shehadeh Agha, MD, PhD, Principal investigator, Damascus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532707
- Sponsor's protocol ID
- UDMS-2026-Neuro-01
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers to maintain patient confidentiality and privacy, as per local institutional regulations
Publications
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.
PubMed 23956564Roper 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.
PubMed 28916122Zain 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.
PubMed 39376877Sanders 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.
PubMed 27358333Raz 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.
PubMed 21670440Gajdos 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.
PubMed 23235588
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07532707
- Acronym / sponsor ID
- UDMS-2026-Neuro-01
- Conditions
- Myasthenic Crisis, Myasthenia Gravis (MG)
- Keywords
- Myasthenia Gravis, Myasthenic Crisis, Intravenous Immunoglobulin (IVIG), Plasma Exchange (PLEX), Quantitative Myasthenia Gravis Score (MGQS), Syria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Collaborators
- Al Mouwasat Hospital, Al-Assad University Hospital
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, non-randomized, parallel-group study comparing the efficacy of IVIG versus Plasma Exchange in patients with Myasthenic Crisis.
| Arm | Type | Receives |
|---|---|---|
| IVIG Group | Experimental | Biological: IVIG (Intravenous Immunoglobulin)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. |
| PLEX Group | Active comparator | Procedure: Plasma exchange (PE)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Biological | IVIG Group |
| 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. | Procedure or surgery | PLEX Group |
Primary outcome
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.
2 secondary outcomes
Presence of Anti-AChR Antibodies.
Time frame: Day 14 post-treatment
Frequency of Myasthenic Crisis Triggers
Time frame: Through hospital discharge, average 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Results publication: PubMed 23956564Sharma 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.
- Results publication: PubMed 28916122Roper 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.
- Results publication: PubMed 39376877Zain 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.
- Results publication: PubMed 27358333Sanders 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.
- Results publication: PubMed 21670440Raz 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.
- Results publication: PubMed 23235588Gajdos 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.
- Study Protocol and Statistical Analysis Plan on OSFLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers to maintain patient confidentiality and privacy, as per local institutional regulations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Shehadeh Agha, MD, PhD principal investigator
Damascus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVIG (Intravenous Immunoglobulin) and Plasma exchange (PE) in people with Myasthenic Crisis and Myasthenia Gravis (MG), run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change from Baseline in the Quantitative Myasthenia Gravis (QMG) Score (time frame: Day 14 post-initiation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07532707, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.