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Could a cancer drug slow MS progression? new trial halted midway

NCT ID NCT05441488

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 This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial tests whether the oral drug masitinib can slow disability worsening in people with progressive multiple sclerosis who do not have relapses. About 800 participants will receive either masitinib or a placebo for 96 weeks. The main goal is to see if masitinib delays confirmed disability progression. The study is currently suspended.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
masitinib
What this could lead to
If successful, masitinib could offer a new oral option to slow disability progression in people with progressive multiple sclerosis who have no relapses.
What could go wrong
This trial is currently suspended, and it is a single phase 3 study. Masitinib may not prove more effective than placebo, and side effects could limit its use.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

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

18 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.

Main inclusion criteria include: * Patients with either primary progressive or secondary progressive multiple sclerosis with onset of symptoms at least five years before baseline and with no relapse diagnosed according to the 2017 revised McDonald's criteria at least two years before screening * Patients with Expanded Disability Status Scale (EDSS) score between 3.0 to 6.0 (both inclusive) at screening and baseline * Patients with an EDSS score progression ≥1 point with no improvement during 2 years * Absence of T1 Gadolinium-enhancing brain lesions as measured by MRI at screening Main exclusion criteria include: * Patients suffering from a disease other than MS that would better explain the patient's neurological clinical signs and symptoms and/or MRI lesions observed at screening * Inability to complete screening MRI (contraindications for MRI) and/or any known allergy or hypersensitivity or any contra-indication to gadolinium macrocyclic * Patients treated with other disease modifying treatments in the time frames and conditions mentioned under previous treatment wash out period, assessed at baseline * Patients with lymphocytes \<1.0 × 10\^9/L at screening and at baseline

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    37 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AHEPA University Hospital, Aristotle University of Thessaloniki

    Thessaloniki, Greece

  • Athens Naval Hospital

    Athens, Greece

  • Azienda Ospedaliero Universitaria Policlinico "G.Rodolico -San Marco"

    Catania, Italy

  • Centre Hospitalier Universitaire Nimes - Service de Neurologie

    Nîmes, France

  • Centre Hospitalier Universitaire Toulouse

    Toulouse, France

  • Centre Hospitalier Universitaire de Rouen

    Rouen, France

  • Centre Hospitalier Universitaire de Strasbourg

    Strasbourg, France

  • Centre hospitalier intercommunal de Poissy-Saint-Germain-en-Laye

    Poissy, France

  • Centrum Neurologii Krzysztof Selmaj

    Lodz, Poland

  • Centrum för neurologi

    Stockholm, Sweden

  • City Hospital No. 40 Kurortny District

    Saint Petersburg, Russia

  • Clinical Best Solutions

    Warsaw, Poland

  • Communal Non-Profit Enterprise "Ternopil Regional Clinical Psychoneurological Hospital" of Ternopil Regional Council, Department of Neurology #1

    Ternopil, Ukraine

  • Eginition Hospital, Athens University Medical School

    Athens, Greece

  • General University Hospital of Larissa

    Larissa, Greece

  • Generała Jarosława Dąbrowskiego

    Oświęcim, Poland

  • Gregorio Marañón General University Hospital

    Madrid, Spain

  • Hospital Clínico San Carlos

    Madrid, Spain

  • Hospital Universitario de Cruces

    Bilbao, Spain

  • Hospital Universitario y Politécnico La Fe

    Valencia, Spain

  • Hospital del Mar

    Barcelona, Spain

  • Hôpital Pasteur - CHU de Nice

    Nice, France

  • Hôpital Roger Salengro

    Lille, France

  • LLC "Center of socially significant diseases"

    Saint Petersburg, Russia

  • Le Centre hospitalier universitaire de Poitiers

    Poitiers, France

  • Lviv Regional Clinical Hospital

    Lviv, Ukraine

  • NOVI-MED

    Ksawerów, Poland

  • NZOZ Neuro-Kard

    Poznan, Poland

  • NZOZ Neuro-Med

    Lublin, Poland

  • Nzoz Neuro-Medic

    Katowice, Poland

  • Perm Regional Clinical Hospital

    Perm, Russia

  • Private Clinic ELPIS

    Volos, Greece

  • Rivne Regional Specialized Dispensary for Radiation Protection of the Population Municipal Enterprise

    Rivne, Ukraine

  • Sahlgrenska University Hospital

    Gothenburg, Sweden

  • Salutem Medical Center

    Vinnytsia, Ukraine

  • Service de Neurologie Hôpital Henri-Mondor

    Créteil, France

  • State Budgetary Institution of Health of the City of Moscow City Polyclinic #2

    Moscow, Russia

More trials for these conditions

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