NCT06949956

Administration of Fingolimod in Greek Patients With Multiple Sclerosis.

Administration of Fingolimod in Greek Patients With Multiple Sclerosis for the Evaluation of the Efficacy and Safety, Based on the Standard Clinical Practice.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 140 (estimated)
• Sponsor: Elpen Pharmaceutical Co. Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 taking fingolimod as part of their regular medical care for MS will answer questions about their medical history for the past 1 year and for their status for the next 2 years.

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 study at 0, 6, 12, 18 and 24 months of treatment * by calculating the change in EDSS score between the 12-month period prior to study entry and that which will occur during the study at 0, 6, 12, 18 and 24 months of treatment.

Conditions

• Relapsing Remitting Multiple Sclerosis

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-04-29
• Last updated: 2025-05-02