Effectiveness and Safety of Generic Delayed-Release Dimethyl Fumarate (Sclera® or Marovarex ®, Hikma) in Routine Medical Practice in the Treatment of Relapsing-Remitting Multiple Sclerosis in MENA Region
NCT ID: NCT04468165
Last Updated: 2023-09-22
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
160 participants
OBSERVATIONAL
2021-02-23
2023-07-20
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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Dimethyl Fumarate (DMF)
Gastro-resistant Hard Capsules. Each capsule contains 240mg or 120mg Dimethyl Fumarate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years
3. Patients who had a diagnosis of RRMS per 2010 or 2017 revised McDonald criteria who are :
1. Newly diagnosed who had no prior DMT, or
2. Switched patients who had ≥1 prior DMTs, other than DMF
4. Patients who agree to participate in the study and provide a written informed consent
Exclusion Criteria
2. Patients participating in other clinical studies
3. Patients who meet any of the contraindications to the administration of the Study drug according to the approved Summary of Product Characteristics
18 Years
ALL
No
Sponsors
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Hikma Pharmaceuticals LLC
INDUSTRY
Responsible Party
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Locations
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CHU Frantz FANON
Blida, , Algeria
Nedir Mohamed Hospital
Tizi Ouzou, , Algeria
New University Hospital
Alexandria, , Egypt
Demerdash hospital (Ain Shams University)
Cairo, , Egypt
Private Clinic
Cairo, , Egypt
King Abdullah University Hospital (KAUH)
Ar Ramtha, , Jordan
Countries
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Other Identifiers
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HIK-DMF-2020-01
Identifier Type: -
Identifier Source: org_study_id
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