RecruitingPhase 4NCT04480853

Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis

A 12-month, Prospective, Multi-center Post-authorization Commitment (PAC) Study Monitoring Safety in Adult Patients With Relapsing-remitting Multiple Sclerosis Newly Initiated on Gilenya (Fingolimod) in Taiwan (SPRING)


Sponsor

Novartis Pharmaceuticals

Enrollment

30 participants

Start Date

Oct 12, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of the study is to describe the safety profile of fingolimod in the Taiwanese multiple sclerosis population. This study aims to collect the safety data in patients newly initiated on fingolimod for one year.


Eligibility

Min Age: 20 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study looks at the safety and effectiveness of fingolimod (a daily oral pill) for treating relapsing-remitting multiple sclerosis (RRMS) in Taiwanese adults. Fingolimod works by reducing the number of immune cells that can attack the nervous system. **You may be eligible if...** - You are a Taiwanese adult aged 20 or older - You have been diagnosed with relapsing-remitting multiple sclerosis (RRMS) - You have not yet taken fingolimod and your doctor is recommending you start it **You may NOT be eligible if...** - You have been diagnosed with neuromyelitis optica (a different nervous system disease) - You are taking any other experimental drug - You have had a heart attack, stroke, or serious heart rhythm problems in the past 6 months - You have certain heart conditions (e.g., heart block) without a pacemaker Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFingolimod

Fingolimod 0.5 mg QD, oral


Locations(6)

Novartis Investigative Site

Kaohsiung City, Taiwan

Novartis Investigative Site

Taichung, Taiwan

Novartis Investigative Site

Tainan, Taiwan

Novartis Investigative Site

Taipei, Taiwan

Novartis Investigative Site

Taipei, Taiwan

Novartis Investigative Site

Taoyuan, Taiwan

View Full Details on ClinicalTrials.gov

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NCT04480853


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