Characteristics and Predictors of Progression of an Egyptian Multiple Sclerosis Cohort

Multiple Sclerosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03004794
• Other study ID #: RC4
• Status: Completed
• Phase: N/A
• First received: December 15, 2016
• Last updated: December 23, 2016
• Start date: June 2015
• Est. completion date: August 2016

Study information

• Verified date: December 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

Patients' records review procedure and sampling strategies. The medical records, administrative data, laboratory and diagnostic tests reports were screened by 3 authors (HS, NS, AE) and these data were extracted in a standard electronic form according to Kasr Alaini Multiple Sclerosis Unit (KAMSU) registry.

An assigned coordinator from each center was requested to facilitate data collection from site-specific records. In cases of incomplete documentation or unclear information, verification was done by on-site data coordinator either by phone contact or face-to-face interview with the patients, whether during the routine follow up or in an unscheduled visit.

Several measures were taken to ensure the confidentiality of the collected information. No patient names were included in the database presented by site coordinator, and the study staff signed a confidentiality agreement for non-disclosure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1581
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• missing data that could not be obtained

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• medical records review

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evoked Potentials (measure latency in m.sec)	Number of patients with delayed latency of Evoked Potentials	13 months (through study completion)	Yes
Primary	Cerebrospinal Fluid (CSF): measure IgG index and Oligoclonal bands (OCB)	Number of patients with elevated IgG index and OCB	13 months (through study completion)	Yes