- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07264725
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
-
-
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Zintan, Libya
- Tripoli University Hospital
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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
|
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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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZFM-2024-MS03
- ZFM/2024/MS-03 (Registry Identifier: Libyan Multiple Sclerosis Registry)
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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