Status:
NOT_YET_RECRUITING
Administration of Fingolimod in Greek Patients With Multiple Sclerosis.
Lead Sponsor:
Elpen Pharmaceutical Co. Inc.
Collaborating Sponsors:
AHEPA University Hospital
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this observational study is to evaluate the efficacy of fingolimod through the estimation of the annualized relapse rate (ARR) over a period of 2 years. Participants who are already takin...
Detailed Description
The efficacy of fingolimod will be assessed: * by calculating the difference in annualized relapse rate (ARR) between the 12-month period prior to study entry and that which will occur during the stu...
Eligibility Criteria
Inclusion
- Patients over 18 years of age.
- Consent and compliance of participants with the treatments and procedures of the study.
- Patients diagnosed with relapsing-remitting multiple sclerosis (RRMS) according to the revised McDonald 2017 criteria.
- Patients who are receiving fingolimod, according to the drug's Summary of product Characteristics (SmPC).
- Patients with available follow-up data for at least 12 months prior to their inclusion in the study, which are sufficient to calculate the annualized relapse rate.
Exclusion
- Patients under 18 years of age.
- Patients with a contraindication to taking fingolimod according to the drug's Summary of product Characteristics (SmPC).
- Patients with a history of mental illness, substance abuse, to a degree that may prevent their participation in the study.
- Patients participating in another research protocol.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06949956
Start Date
June 1 2025
End Date
December 31 2027
Last Update
May 2 2025
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