← Back to Clinical Trials
Recruiting Phase 4 NCT04480853

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

Trial Parameters

Condition Multiple Sclerosis
Sponsor Novartis Pharmaceuticals
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 30
Sex ALL
Min Age 20 Years
Max Age 100 Years
Start Date 2020-10-12
Completion 2027-09-30
Interventions
Fingolimod

Brief 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 Criteria

Inclusion Criteria: -Patients with relapsing-remitting multiple sclerosis that are fingolimod treatment naive at the time of study entry and are newly starting fingolimod based on physician judgement and according to Taiwan's fingolimod package insert (version TWI-090420) Exclusion Criteria: * Patients with the diagnosis of neuromyelitis optica. * Patients who are being treated with any investigational drug at the time of study entry. * In the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization or Class III/IV heart failure * A history or presence of Mobitz Type II second-degree or third-degree atrioventricular block or sick sinus syndrome, unless patient has a functioning pacemaker * A baseline QTc interval ≥ 500 msec * Cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs * Patient with known immune deficiency, increased risk of opp

Related Trials