Multiple SclerosisNCT07264725
Libyan Multiple Sclerosis Registry Study
An observational study of Multiple Sclerosis, run by University of Zintan at 1 site in Libya.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Disease-Modifying Therapies
- How many people
- 369 participants
- Where
- 1 siteLibya
- Study dates
- 2 Aug 2023to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Libya1 site
Tripoli University Hospital
Zintan
About this study
Official title: 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Disease-Modifying Therapies
- Keywords
- Multiple Sclerosis MS Relapsing-Remitting MS Secondary Progressive MS Primary Progressive MS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disease-Modifying TherapiesDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate-to-Severe Disability (EDSS ≥3.0)
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.
Measured: At registry entry
Moderate-to-Severe Disability (EDSS ≥3.0)
Measured: At registry entry
Secondary outcomes (1)
EDSS Ordinal Disability Categories
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.
Measured: At registry entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start2 Aug 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zintan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264725
- Sponsor's protocol ID
- ZFM-2024-MS03
- Other IDs
- ZFM/2024/MS-03
- Status last verified
- Nov 2025
- First submitted
- 23 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Sclerosis Care in a Conflict-Affected Health System: Diagnostic Delay, Treatment Access, and Disability Outcomes in Libya
- ClinicalTrials.gov ID
- NCT07264725
- Acronym / sponsor ID
- ZFM-2024-MS03
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis MS Relapsing-Remitting MS Secondary Progressive MS Primary Progressive MS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- University of ZintanUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disease-Modifying TherapiesThis 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. | Drug | – |
Primary outcome
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.
Moderate-to-Severe Disability (EDSS ≥3.0)
Time frame: At registry entry
1 secondary outcome
EDSS Ordinal Disability Categories
Time frame: At registry entry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University of Zintan at 1 site in Libya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Libya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate-to-Severe Disability (EDSS ≥3.0) (time frame: At registry entry). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.