NCT06774937

Brief Summary

This study includes clinical and laboratory studies of patients with Myathenia gravis at Sohag Neurology outpatient clinic of pediatric department

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

January 14, 2025

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

December 11, 2024

Last Update Submit

January 13, 2025

Conditions

Outcome Measures

Primary Outcomes (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.

    Follow up for 6 months

Study Arms (1)

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.

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 hisDiagnostic Test: EMG ,rNST,Ach R antibodies & thyroid function

Interventions

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: 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).

One group of patients againg one month to 16 years old with myasthenia gravis

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).

One group of patients againg one month to 16 years old with myasthenia gravis

Eligibility Criteria

Age1 Month - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Failure to obtain informed consent. Other neurological and neuromuscular disorders. Age above 16 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sohag University Hospital

Sohag, Sohag Governorate, Egypt

Location

Sohag university

Sohag, Egypt

Location

Sohag university

Sohag, Egypt

Location

MeSH Terms

Interventions

Sex

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor of pediatric in ElHelal Hospital in Sohag

Study Record Dates

First Submitted

December 11, 2024

First Posted

January 14, 2025

Study Start

February 1, 2025

Primary Completion

May 1, 2025

Study Completion

August 1, 2025

Last Updated

January 14, 2025

Record last verified: 2024-06

Locations