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Completed

NCT Number: NCT07264725

Libyan Multiple Sclerosis Registry Study

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tripoli University Hospital

Zintan, Libya

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Disease-Modifying Therapies

Drug

This is an observational study. No medications are assigned, administered, or modified by the study team. Disease-modifying therapies (DMTs) are recorded only as exposure variables based on routine clinical care. All drugs listed in this record are prescribed independently by treating neurologists as part of standard care, and the study does not influence treatment decisions in any way.

Primary outcomes

  1. 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.

  2. Moderate-to-Severe Disability (EDSS ≥3.0)

    Time frame: At registry entry

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Zintan

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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