NCT03360188

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
237

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

June 1, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 4, 2017

Completed
Last Updated

December 5, 2017

Status Verified

December 1, 2017

Enrollment Period

4.5 years

First QC Date

November 28, 2017

Last Update Submit

December 1, 2017

Conditions

Outcome Measures

Primary Outcomes (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)

    up to 150 months

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • MS mimics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of Neurology - Cairo University

Study Record Dates

First Submitted

November 28, 2017

First Posted

December 4, 2017

Study Start

June 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 5, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share