Running, not recruitingPhase 4Relapsing MSNCT04480853

What it found

Still running

No result yet.

What was tested

Treatment tested

What it measured

Main measures

  • Number of Adverse Events of Special Interest(AESI)

    First Dose Observation on the first day of taking findolimod

    Safety
  • Number of Adverse Events of Special Interest (AESI)

    Baseline up to 12 months

    Immune responseSafety

Other measures (3)

  • Annualized relapse reate (ARR)

    Baseline up to 12 months

    Relapses
  • Change from baseline of Pulse (beats/min)

    Baseline up to 12 months

    Safety
  • Change from baseline of blood pressure (mmHg)

    Baseline up to 12 months

    Safety

Who could take part

Relapsing MS · 20 to 100

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 opportunistic infection, severe active infection or chronic active infection. * Patients with severe active malignancies, except for basal cell epithelioma * Patients with severe hepatic insufficiency * Pregnant or nursing (lactating) women or women of childbearing potential unless on contraception

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    Related trials

    History

    1. Status changed from Recruiting to Running, not recruiting
    2. Enrollment changed from 30 to 14
    3. Primary completion date changed from 2027-09-30 to 2026-10-15
    1. Started

      Oct 2020

    2. Main results due

      Oct 2026

    3. Finished

      Sept 2027

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