Characteristics and Predictors of Progression of an Egyptian Multiple Sclerosis Cohort

NCT03004794 | Completed

• 1 other identifier: RC4
• Study Type: observational
• Target: 1,581
• Locations: 0 countries
• Sites: N/A

Brief Summary

Initial recruitment: 1717, 136 (7.92%) were excluded due to missing data that could not be obtained. The diagnosis of multiple sclerosis (MS) was revised according to the 2010 revision of the McDonald criteria. Patients analyses: 1581 Every patient was registered by his/her 14-digit unique identity numbers, (which is mandatory in Egypt since 1999) to make sure that every registered patient in different centers were counted only once.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Evoked Potentials (measure latency in m.sec)

  Number of patients with delayed latency of Evoked Potentials

  13 months (through study completion)

• Cerebrospinal Fluid (CSF): measure IgG index and Oligoclonal bands (OCB)

  Number of patients with elevated IgG index and OCB

  13 months (through study completion)

Interventions

medical records review OTHER

Eligibility Criteria

• Age: 6 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The diagnosis of multiple sclerosis (MS) was revised according to the 2010 revision of the McDonald criteria, and patients were classified according to the course of the disease into relapsing remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) and primary-progressive multiple sclerosis (PPMS). Patients with first demyelinating event, before 2010, were re-assessed by on-site coordinators to label them clinically isolated syndrome (CIS), whenever applicable, according to McDonalds 2010, and neuromyelitis optica (NMO) cases diagnosis was verified according to the 2015 diagnostic criteria. Those with typical brain Magnetic Resonant Imaging (MRI) MS like lesions without related clinical manifestations were diagnosed as radiologically isolated syndrome (RIS).

You may qualify if:

• All patients with suspecting multiple sclerosis attending 4 tertiary referral centers in Egypt

You may not qualify if:

• missing data that could not be obtained

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 29, 2016
• Study Start: June 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 29, 2016

Record last verified: 2016-12