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Multiple Sclerosis in ChildrenNCT03360188

Pediatric Onset Multiple Sclerosis in Egyptians

An observational study of Multiple Sclerosis in Children, run by Cairo University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A medical record review of historic and current information on 237 patients attending 5 tertiary referral centers [Kasr Al-Ainy Multiple Sclerosis Research Unit (KAMSU) - Cairo University Hospitals, Abo El Reesh Pediatric Hospital and 3 private centers] in Cairo, Egypt from period between 2011 and December 2015. Read more about this study

Who is it for?
Ages 6 to 18 years
Conditions the study is for
Multiple Sclerosis in Children
How many people
237 participants
Where
No sites listed yet
Study dates
Jun 2011to Dec 2015
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 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: A total of 237 patients were finally analyzed in the current study, 64.56% (153) were females and 35.44% (84) were males. At time of data collection; MS was diagnosed in 186 patients (78.48%); and the diagnosis of 10 patients (4.22%) were not yet settled. We identified 47/186 patients (25.27%) with EOPMS. Positive family history of MS [at least one first and/or second degree relatives] was reported in 15/186 patients (8.06%). The median (IQR) time between the first manifestation and confirmation of the diagnosis was 6 months (3 - 9) months.

Who may be able to join

  • All included patients had the onset of the first symptoms before the age of 18 years; and they were further classified into (1) below 12 years old or early-onset pediatric multiple sclerosis (EOPMS), and (2) ≥12 years old or late-onset pediatric MS (LOPMS) according to The International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria

Who cannot join

  • MS mimics

About this study

Official title: Pediatric Multiple Sclerosis in Egypt. A Multi-center Registry of 186 Patients

A medical record review of historic and current information on 237 patients attending 5 tertiary referral centers [Kasr Al-Ainy Multiple Sclerosis Research Unit (KAMSU) - Cairo University Hospitals, Abo El Reesh Pediatric Hospital and 3 private centers] in Cairo, Egypt from period between 2011 and December 2015.

Initially, medical records of 251 patients with the first acquired demyelinating events started before age of 18 years were reviewed. Fourteen patients (5.58%) were excluded due to missing data that could not be obtained.

Read the detailed description

The International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria were applied on all included patients who were stratified into the following groups: (1) those with 2 or more non-encephalopathic clinical CNS events (NEE) separated by > 30 days and involving > one area of the CNS; (2) one non-encephalopathic episode typical of MS which is associated with MRI findings consistent with 2010 Revised McDonald criteria for dissemination in space and in which a follow up MRI shows at least one new enhancing or non-enhancing lesion consistent with dissemination in time MS criteria; (3) one acute disseminated encephalomyelitis (ADEM) attack followed by a non-encephalopathic clinical event, 3 or more months after symptom onset, that is associated with new MRI lesions fulfilling 2010 Revised McDonald DIS criteria; or (4) a first, single, acute event that does not meet ADEM criteria and whose MRI findings are consistent with the 2010 Revised McDonald criteria for DIS and DIT (applies only to children ≥12 years old).

These criteria were applied retrospectively in patients diagnosed before 2013. Procedures All medical records were analyzed from June 2016 till April 2017 to collect the following data; (1) demographic characteristics; (2) clinical data including age at first symptoms, age at diagnosis, disease course, time to conversion to secondary progressive (SP) course, duration of follow-up, initial and last Expanded Disability Status Scale (EDSS) score, time to (EDSS) score of 4, family history of MS, disease-modifying treatments (DMTs), number of relapses in the first year and the annualized relapse rate (ARR); (3) laboratorial data: oligoclonal bands in the cerebrospinal fluid (CSF) and IgG index; (4) characteristics of the initial magnetic resonance imaging (MRI) of the brain and spinal cord including: typicality of lesions on T2 weighted sequence, presence of brain black holes in T1 weighted sequence, presence of spinal cord T2 lesions, presence of gadolinium (Gd) enhancing lesions, distribution of brain lesions (supratentorial and/or infratentorial).

Data quality. To ensure high-quality data, the accuracy and completeness were systemically assessed. The medical records, administrative data, laboratory and diagnostic tests reports were screened independently by 2 authors (NS and AE) and relevant data was extracted to a standard electronic form according to KAMSU registry. An assigned coordinator from each center was requested to facilitate data collection from site-specific records; an audit site-specific data abstractor was continuously monitoring the records. Data accuracy was checked by separate investigators (MA, HS, AH) who reviewed the electronic forms for resemblance. Scheduled monthly meetings between abstractors were held to resolve any data conflicts. In case of incomplete documentation or unclear information, verification was done by the on-site data coordinator either by phone or during a face-to-face interview with the patients or caregivers during routine follow up or unscheduled visits.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. time to EDSS 4

    The time to EDSS 4 from symptoms onset in relation to initiation of Disease Modified Therapies (before/after 1 year of symptoms onset)

    Measured: up to 150 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2017
  2. Study startJun 2011
  3. Primary completionDec 2015
  4. Study completionDec 2015

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
Cohort
Time perspective
Retrospective
Enrolment
237 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03360188
Sponsor's protocol ID
POMS1
Status last verified
Dec 2017
First submitted
28 Nov 2017
Last updated
5 Dec 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis in Children, run by Cairo University.

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 1 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: finished, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

time to EDSS 4 (time frame: up to 150 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 5 Dec 2017.

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