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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in Egypt

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:

  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).
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:

    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:
    3. Electrophysiological testing: EMG : is especially useful in diagnosis of seronegative MG and congenital myasthenic syndromes. NCS: including repetitive nerve stimulation test (r NST)
    4. 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 :
    1. Imaging:
    • CT chest: Although thymoma in children is rare, the thymus must be imaged once JMG has been diagnosed.
    1. molecular studies (when possible).
  • EMG ,rNST,Ach R antibodies & thyroid functionDiagnostic test

    1. Investigations:
    2. Electrophysiological testing: EMG : is especially useful in diagnosis of seronegative MG and congenital myasthenic syndromes. NCS: including repetitive nerve stimulation test (r NST)
    3. 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 :
    1. Imaging:
    • CT chest: Although thymoma in children is rare, the thymus must be imaged once JMG has been diagnosed.
    1. molecular studies (when possible).
Study groups in NCT06774937
Study groupRoleWhat they receive
One group of patients againg one month to 16 years old with myasthenia gravisPatients 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.

  1. 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.

  1. First posted14 Jan 2025
  2. Study start1 Feb 2025 (estimated)
  3. Primary completion1 May 2025 (estimated)
  4. Study completion1 Aug 2025 (estimated)

Resources

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)
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

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.

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