Libyan Multiple Sclerosis Registry Study

November 23, 2025 updated by: University of Zintan

Multiple Sclerosis Care in a Conflict-Affected Health System: Diagnostic Delay, Treatment Access, and Disability Outcomes in Libya

This study aims to understand differences in access to diagnosis and treatment for people with multiple sclerosis (MS) receiving care in Libya. The study uses data from the Libyan Multiple Sclerosis Registry, which collects clinical and treatment information from patients at two tertiary neurology centres. The main focus is to examine how long it takes for patients to receive an MS diagnosis, who has access to high-efficacy disease-modifying therapies, and how these factors relate to disability levels. The results will help identify gaps in MS care within a conflict-affected health system and guide improvements in services for patients in Libya.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

369

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zintan, Libya
        • Tripoli University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults with multiple sclerosis receiving neurological care at two tertiary centres in western Libya: Tripoli University Hospital in Tripoli and Omar Askar Hospital in Zliten. Patients are enrolled into the Libyan Multiple Sclerosis Registry during routine clinical visits, with disability assessments and treatment information recorded by trained neurologists. The study population reflects a broad range of MS phenotypes, socioeconomic backgrounds, and treatment exposures within a conflict-affected health system.

Description

Inclusion Criteria:

  • Adults aged 18 years or older
  • Diagnosis of multiple sclerosis according to the 2017 McDonald criteria
  • Receiving care at Tripoli University Hospital or Omar Askar Hospital
  • Able to provide written informed consent
  • Recorded EDSS score at registry entry
  • Availability of core demographic and diagnostic information

Exclusion Criteria:

  • Clinically isolated syndrome (CIS)
  • Age younger than 18 years
  • Absence of confirmed multiple sclerosis diagnosis
  • Missing key clinical variables required for primary analysis (EDSS, phenotype, or DMT information)
  • Declined or unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Moderate-to-Severe Disability (EDSS ≥3.0)
Time Frame: At registry entry
Disability measured using the Expanded Disability Status Scale (EDSS). Moderate-to-severe disability is defined as EDSS ≥3.0, assessed by trained neurologists using standardised procedures.
At registry entry
Moderate-to-Severe Disability (EDSS ≥3.0)
Time Frame: At registry entry
At registry entry

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EDSS Ordinal Disability Categories
Time Frame: At registry entry

Disability severity categorised using the Expanded Disability Status Scale (EDSS) into three groups:

0-2.5 (mild), 3.0-5.5 (moderate), and ≥6.0 (severe). EDSS scores are assessed by trained neurologists at the time of registry entry.

At registry entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2023

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

April 30, 2025

Study Registration Dates

First Submitted

November 23, 2025

First Submitted That Met QC Criteria

November 23, 2025

First Posted (Estimated)

December 4, 2025

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

November 23, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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