Myasthenia Gravis in ChildrenNCT06774937
Clinical and Laboratory Profile of Myasthenia Gravis in Children At Sohag University Hospitals
An observational study of Myasthenia Gravis in Children, run by Sohag University at 3 sites in Egypt.
Trial summary
This study includes clinical and laboratory studies of patients with Myathenia gravis at Sohag Neurology outpatient clinic of pediatric department Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Myasthenia Gravis in Children
- What is being tested?
- All patients in this study were subjected to the followings: (A) Clinical history focusing on: Sociodemographic data: age, gender , residence,and degree of consanguinity. Full neurodevelopmental his and EMG ,rNST,Ach R antibodies & thyroid function
- How many people
- 20 participants
- Where
- 3 sitesEgypt
- Study dates
- 1 Feb 2025to 1 Aug 2025
- Phase
- Observational
- 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 1 month to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients: Patients diagnosed with myasthenia gravis at the pediatric out patient clinic by clinical charactristics ,nerve study and laboratory data will be elligable for the study.
Who may be able to join
- All patients from 1 month to 16 years confirmed diagnosis of myasthenia gravis by neurological and laboratory data.
- Care giver accept to participate in the study.
Who cannot join
- Failure to obtain informed consent. Other neurological and neuromuscular disorders. Age above 16 years.
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Sohag University Hospital
Sohag, Sohag Governorate
Sohag university
Sohag
Sohag university
Sohag
Menna Mohamed Resident doctor of pediatric at El Helal hospital, Resident doctor of pediatric, 01011707915 ext. 01011707915, Mena011195@med.sohag.edu.eg
About this study
This study includes clinical and laboratory studies of patients with Myathenia gravis at Sohag Neurology outpatient clinic of pediatric department
Read the detailed description
All patients in this study were subjected to the followings:
(A) Clinical history focusing on: Sociodemographic data: age, gender , residence,and degree of consanguinity. Full neurodevelopmental history: neurological evaluation Family history. Mode of delivery
(B) Thorough clinical examination: General examination including general look, vital signs and anthropometric measurements.
Scale system include gross motor function and muscle power(Quantitative Myasthenia Gravis Scale) [36] detailed neurological examination including motor ,sensory and reflexes. (C) Investigations:
- Electrophysiological testing: EMG : is especially useful in diagnosis of seronegative MG and congenital myasthenic syndromes. NCS: including repetitive nerve stimulation test (r NST)
- laboratory studies: Serology. Detection of antibodies to the AChR supports the diagnosis of JMG. In young children where AChR antibodies are negative this can lead to difficulty in differentiating from CMS. Thyroid function tests :
- Imaging: CT chest: Although thymoma in children is rare, the thymus must be imaged once JMG has been diagnosed.
- molecular studies (when possible).
- Conditions
- Myasthenia Gravis in Children
- Being tested
- All patients in this study were subjected to the followings: (A) Clinical history focusing on: Sociodemographic data: age, gender , residence,and degree of consanguinity. Full neurodevelopmental his, EMG ,rNST,Ach R antibodies & thyroid function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All patients in this study were subjected to the followings: (A) Clinical history focusing on: Sociodemographic data: age, gender , residence,and degree of consanguinity. Full neurodevelopmental hisDiagnostic test
Thorough clinical examination:
- General examination including general look, vital signs and anthropometric measurements.
- Scale system include gross motor function and muscle power(Quantitative Myasthenia Gravis Scale) [36] 3. detailed neurological examination including motor ,sensory and reflexes. (C) Investigations:
- Electrophysiological testing: EMG : is especially useful in diagnosis of seronegative MG and congenital myasthenic syndromes. NCS: including repetitive nerve stimulation test (r NST)
- laboratory studies:
- Serology. Detection of antibodies to the AChR supports the diagnosis of JMG. In young children where AChR antibodies are negative this can lead to difficulty in differentiating from CMS.
- Thyroid function tests :
- Imaging:
- CT chest: Although thymoma in children is rare, the thymus must be imaged once JMG has been diagnosed.
- molecular studies (when possible).
EMG ,rNST,Ach R antibodies & thyroid functionDiagnostic test
- Investigations:
- Electrophysiological testing: EMG : is especially useful in diagnosis of seronegative MG and congenital myasthenic syndromes. NCS: including repetitive nerve stimulation test (r NST)
- laboratory studies:
- Serology. Detection of antibodies to the AChR supports the diagnosis of JMG. In young children where AChR antibodies are negative this can lead to difficulty in differentiating from CMS.
- Thyroid function tests :
- Imaging:
- CT chest: Although thymoma in children is rare, the thymus must be imaged once JMG has been diagnosed.
- molecular studies (when possible).
| Study group | Role | What they receive |
|---|---|---|
| One group of patients againg one month to 16 years old with myasthenia gravis | Patients diagnosed with myasthenia gravis at the pediatric out patient clinic by clinical charactristics ,nerve study and laboratory data will be elligable for the study.
Inclusion Criteria:
* All patients from 1 month to 16 years confirmed diagnosis of myasthenia gravis by neurological and laboratory data.
* Care giver accept to participate in the study. Receives: Diagnostic Test: All patients in this study were subjected to the followings: (A) Clinical history focusing on: Sociodemographic data: age, gender , residence,and degree of consanguinity. Full neurodevelopmental his; Diagnostic Test: EMG ,rNST,Ach R antibodies & thyroid function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and laboratory profile of patients with myasthenia gravis at Sohag Neurology Outpatient clinic of pediatric department
All patients with myasthenia gravis in this study focusing on clinical and laboratory profile at Sohag Neurology outpatient clinic.
Measured: Follow up for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia Gravis in ChildrenStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menna Mohamed Sedik, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774937
- Sponsor's protocol ID
- Soh-Med-24-09-03MS
- Status last verified
- Jun 2024
- First submitted
- 11 Dec 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Laboratory Profile of Myasthenia Gravis in Children At Sohag University Hospitals
- ClinicalTrials.gov ID
- NCT06774937
- Acronym / sponsor ID
- Soh-Med-24-09-03MS
- Conditions
- Myasthenia Gravis in Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 14 Jan 2025 (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 includes clinical and laboratory studies of patients with Myathenia gravis at Sohag Neurology outpatient clinic of pediatric department
Detailed description
All patients in this study were subjected to the followings:
(A) Clinical history focusing on: Sociodemographic data: age, gender , residence,and degree of consanguinity. Full neurodevelopmental history: neurological evaluation Family history. Mode of delivery
(B) Thorough clinical examination: General examination including general look, vital signs and anthropometric measurements.
Scale system include gross motor function and muscle power(Quantitative Myasthenia Gravis Scale) [36] detailed neurological examination including motor ,sensory and reflexes. (C) Investigations:
- Electrophysiological testing: EMG : is especially useful in diagnosis of seronegative MG and congenital myasthenic syndromes. NCS: including repetitive nerve stimulation test (r NST)
- laboratory studies: Serology. Detection of antibodies to the AChR supports the diagnosis of JMG. In young children where AChR antibodies are negative this can lead to difficulty in differentiating from CMS. Thyroid function tests :
- Imaging: CT chest: Although thymoma in children is rare, the thymus must be imaged once JMG has been diagnosed.
- molecular studies (when possible).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One group of patients againg one month to 16 years old with myasthenia gravis | – | Diagnostic Test: All patients in this study were subjected to the followings: (A) Clinical history focusing on: Sociodemographic data: age, gender , residence,and degree of consanguinity. Full neurodevelopmental his, Diagnostic Test: EMG ,rNST,Ach R antibodies & thyroid functionPatients diagnosed with myasthenia gravis at the pediatric out patient clinic by clinical charactristics ,nerve study and laboratory data will be elligable for the study. Inclusion Criteria: * All patients from 1 month to 16 years confirmed diagnosis of myasthenia gravis by neurological and laboratory data. * Care giver accept to participate in the study. |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients: Patients diagnosed with myasthenia gravis at the pediatric out patient clinic by clinical charactristics ,nerve study and laboratory data will be elligable for the study.
Key inclusion criteria (2 listed)
- All patients from 1 month to 16 years confirmed diagnosis of myasthenia gravis by neurological and laboratory data.
- Care giver accept to participate in the study.
Key exclusion criteria (1 listed)
- Failure to obtain informed consent. Other neurological and neuromuscular disorders. Age above 16 years.
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 |
|---|---|---|
| All patients in this study were subjected to the followings: (A) Clinical history focusing on: Sociodemographic data: age, gender , residence,and degree of consanguinity. Full neurodevelopmental hisThorough clinical examination: 1. General examination including general look, vital signs and anthropometric measurements. 2. Scale system include gross motor function and muscle power(Quantitative Myasthenia Gravis Scale) [36] 3. detailed neurological examination including motor ,sensory and reflexes. (C) Investigations: 1. Electrophysiological testing: EMG : is especially useful in diagnosis of seronegative MG and congenital myasthenic syndromes. NCS: including repetitive nerve stimulation test (r NST) 2. laboratory studies: * Serology. Detection of antibodies to the AChR supports the diagnosis of JMG. In young children where AChR antibodies are negative this can lead to difficulty in differentiating from CMS. * Thyroid function tests : 3. Imaging: • CT chest: Although thymoma in children is rare, the thymus must be imaged once JMG has been diagnosed. 4. molecular studies (when possible). | Diagnostic test | One group of patients againg one month to 16 years old with myasthenia gravis |
| EMG ,rNST,Ach R antibodies & thyroid functionC) Investigations: 1. Electrophysiological testing: EMG : is especially useful in diagnosis of seronegative MG and congenital myasthenic syndromes. NCS: including repetitive nerve stimulation test (r NST) 2. laboratory studies: * Serology. Detection of antibodies to the AChR supports the diagnosis of JMG. In young children where AChR antibodies are negative this can lead to difficulty in differentiating from CMS. * Thyroid function tests : 3. Imaging: • CT chest: Although thymoma in children is rare, the thymus must be imaged once JMG has been diagnosed. 4. molecular studies (when possible). | Diagnostic test | One group of patients againg one month to 16 years old with myasthenia gravis |
Primary outcome
Clinical and laboratory profile of patients with myasthenia gravis at Sohag Neurology Outpatient clinic of pediatric department
Time frame: Follow up for 6 months
All patients with myasthenia gravis in this study focusing on clinical and laboratory profile at Sohag Neurology outpatient clinic.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis in Children, run by Sohag University at 3 sites in Egypt.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Menna Mohamed (01011707915, Mena011195@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and laboratory profile of patients with myasthenia gravis at Sohag Neurology Outpatient clinic of pediatric department (time frame: Follow up for 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2025.