NCT05423769Completed
Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt
Source: ClinicalTrials.gov · Last updated 23 Aug 2024
Brief summary (registry, in English)
The purpose of this observational study is to evaluate the Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients with Relapsing-Remitting Multiple Sclerosis in Egypt
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 30 (actual)
- First submitted
- 14 Jun 2022
- Start date
- Jan 2022
- Primary completion date
- Nov 2023
- Lead sponsor
- Hikma Pharmaceuticals LLC
- Diseases
- Multiple sclerosis
- NCT number
- NCT05423769
What you commit to
- Study type: Observational
- Participants enrolled: 30
- From Jan 2022 to the primary completion date, Nov 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who meet any of the contraindications to the administration of the study drug according to the approved SPC.
Other
- Pregnant or lactating female patients and women of childbearing potential not using effective contraception.
- Patients lacking immunity against varicella zoster virus (VZV).
- Patients participating in other clinical studies.
Who the study is looking for
- Patients who initiate treatment with generic Fingolimod at baseline in accordance with the approved summary of product characteristics (SPC).
- Males and females who are ≥ 18 years old.
- Patients who had a diagnosis of RRMS per 2010 or 2017 revised McDonald criteria, who are:
- Newly diagnosed who had no prior Disease-Modifying Therapy (DMT), or
- Switched patients from Gilenya®, Novartis, or
- Switched patients from interferon beta (IFNβ).
- Patients who agree to participate in the study and provide a written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neuropsychiatry department, Faculty of Medicine, Alexandria University Hospitals, Hadra University Hospital Coordinator of this site? Confirm its status | Alexandria | Egypt | Unknown status |
| Faculty of medicine Ain shams Research Institute-Clinical Research Center (MASRI-CRC) Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.