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New hope for chinese MS patients: fingolimod shows promise in reducing relapses

NCT ID NCT04667949

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how well and how safely the drug fingolimod (Gilenya) works for people in China with relapsing multiple sclerosis (RMS), a condition where the immune system attacks the nerves. Over 24 months, 98 participants took a daily 0.5 mg pill. The main goal was to see if it lowered the number of MS attacks (relapses). The study also tracked side effects. Fingolimod is not a cure, but it helps control the disease by reducing flare-ups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

98 people

The number who actually took part.

Started

Feb 2021

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant 10 to 17 years old inclusive with weight \> 40kg. * Participant 18 to 65 years old inclusive; * Participants with relapsing multiple sclerosis * Participants never used fingolimod before enrollment * Subjects with Expanded Disability Status Scale (EDSS) score of 0 - 6.0 (inclusive) at Screening Exclusion Criteria: * Participants with certain cardiovascular conditions and/or findings in the screening ECG. * Diagnosis of macular edema during screening visit. * Increased risk for opportunistic infections * Participants with known active malignancies. * Participants who have been treated with teriflunomide within 3.5 months prior to baseline, except if active washout. * Participants with severe active infections, active chronic infection. * Participants with severe liver impairment. * Pregnant confirmed by a positive pregnancy test or nursing (lactating) women.

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Conditions

The condition(s) this trial relates to.

relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsing multiple sclerosis (RMS)

Contacts and locations

Locations

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100000, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510623, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510630, China

  • Novartis Investigative Site

    Zhengzhou, Henan, 450052, China

  • Novartis Investigative Site

    Wuhan, Hubei, 430030, China

  • Novartis Investigative Site

    Suzhou, Jiangsu, 215004, China

  • Novartis Investigative Site

    Changchun, Jilin, 130021, China

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    Wenzhou, Zhejiang, 325000, China

  • Novartis Investigative Site

    Beijing, 065001, China

  • Novartis Investigative Site

    Beijing, 100028, China

  • Novartis Investigative Site

    Guangzhou, 510260, China

  • Novartis Investigative Site

    Shanghai, 200040, China

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