Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt
NCT ID: NCT05423769
Last Updated: 2024-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2022-01-19
2023-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Fingolimod
0.5 mg hard gelatine capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Males and females who are ≥ 18 years old.
3. Patients who had a diagnosis of RRMS per 2010 or 2017 revised McDonald criteria, who are:
1. Newly diagnosed who had no prior Disease-Modifying Therapy (DMT), or
2. Switched patients from Gilenya®, Novartis, or
3. Switched patients from interferon beta (IFNβ).
4. Patients who agree to participate in the study and provide a written informed consent.
Exclusion Criteria
2. Patients lacking immunity against varicella zoster virus (VZV).
3. Patients participating in other clinical studies.
4. Patients who meet any of the contraindications to the administration of the study drug according to the approved SPC.
18 Years
ALL
No
Sponsors
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Hikma Pharmaceuticals LLC
INDUSTRY
Responsible Party
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Locations
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Neuropsychiatry department, Faculty of Medicine, Alexandria University Hospitals, Hadra University Hospital
Alexandria, , Egypt
Faculty of medicine Ain shams Research Institute-Clinical Research Center (MASRI-CRC)
Cairo, , Egypt
Countries
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Other Identifiers
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HIK-SPH-2021-01
Identifier Type: -
Identifier Source: org_study_id
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