Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Italian MS patients on mayzent show promise in slowing disability over 3 years

NCT ID NCT05376579

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 followed 134 adults in Italy with active secondary progressive multiple sclerosis who were prescribed siponimod (Mayzent) as part of their routine care. Over 36 months, researchers measured how many patients experienced a confirmed worsening of disability or cognitive decline. The goal was to see if the drug helps control the disease and slow progression in real-world settings.

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.

Participants

134 people

The number who actually took part.

Started

Jun 2022

Finished

Jul 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.

Who is studied

patients in Italy with active SPMS treated with siponimod as per label and local clinical practice.

Ages

18 to 60 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: 1. Signed informed consent: patient must provide written informed consent before any study assessment is performed. 2. Male/female participants aged between 18 and 60. 3. Documented diagnosis of active SPMS. 4. Siponimod treatment as routine medical care: patients newly treated with siponimod (starting not more than 7 days before baseline visit), for whom the decision to start treatment has already been taken independently of study inclusion based on clinical practice and according to SmPC and AIFA criteria, and who successfully qualified for treatment with siponimod (i.e. passed the screening procedure mandated by the SmPC and Risk Management Plan (RMP) for this treatment, including genotyping for CYP2C9 to determine CYP2C9 metaboliser status). Exclusion Criteria: 1. Patients treated outside the approved siponimod label or with any controindication indicated in the SmPC. 2. Pregnant or lactating women. 3. Patients with any clinical condition that may interfere with the subject's ability to cooperate and comply with the study procedures based on the investigator's judgement. 4. Current participation in an interventional trial. 5. Treatment with siponimod prior to inclusion in this study (siponimod can be started not more than 7 days before baseline visit).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Active secondary progressive multiple sclerosis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

chronic progressive multiple sclerosis secondary progressive multiple sclerosis

As listed by the trial registrant

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

Active secondary progressive multiple sclerosis

Contacts and locations

Locations

  • Novartis Investigative Site

    Ancona, AN, 60126, Italy

  • Novartis Investigative Site

    L’Aquila, AQ, 67100, Italy

  • Novartis Investigative Site

    Bergamo, BG, 24127, Italy

  • Novartis Investigative Site

    Bologna, BO, 40124, Italy

  • Novartis Investigative Site

    Brescia, BS, 25123, Italy

  • Novartis Investigative Site

    Como, CO, 22100, Italy

  • Novartis Investigative Site

    Catanzaro, CZ, 88100, Italy

  • Novartis Investigative Site

    Foggia, FG, 71122, Italy

  • Novartis Investigative Site

    Genova, GE, 16132, Italy

  • Novartis Investigative Site

    Messina, ME, 98124, Italy

  • Novartis Investigative Site

    Milan, MI, 20133, Italy

  • Novartis Investigative Site

    Palermo, PA, 90127, Italy

  • Novartis Investigative Site

    Padova, PD, 35128, Italy

  • Novartis Investigative Site

    Pisa, PI, 56126, Italy

  • Novartis Investigative Site

    Pavia, PV, 27100, Italy

  • Novartis Investigative Site

    Roma, RM, 00133, Italy

  • Novartis Investigative Site

    Roma, RM, 00152, Italy

  • Novartis Investigative Site

    Roma, RM, 00189, Italy

  • Novartis Investigative Site

    Orbassano, TO, 10043, Italy

  • Novartis Investigative Site

    Trieste, TS, 34149, Italy

  • Novartis Investigative Site

    Vicenza, VI, 36100, Italy

  • Novartis Investigative Site

    Naples, 80131, Italy

  • Novartis Investigative Site

    Naples, 80138, Italy

  • Novartis Investigative Site

    Novara, 28100, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.