Could a cancer drug slow MS progression? new trial halted midway
NCT ID NCT05441488
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 800 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Get notified about this study
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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.
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The places running it
37 sites in 8 countries. The list below names each one and where it is.
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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.
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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
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AHEPA University Hospital, Aristotle University of Thessaloniki
Thessaloniki, Greece
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Athens Naval Hospital
Athens, Greece
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Azienda Ospedaliero Universitaria Policlinico "G.Rodolico -San Marco"
Catania, Italy
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Centre Hospitalier Universitaire Nimes - Service de Neurologie
Nîmes, France
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Centre Hospitalier Universitaire Toulouse
Toulouse, France
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Centre Hospitalier Universitaire de Rouen
Rouen, France
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Centre Hospitalier Universitaire de Strasbourg
Strasbourg, France
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Centre hospitalier intercommunal de Poissy-Saint-Germain-en-Laye
Poissy, France
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Centrum Neurologii Krzysztof Selmaj
Lodz, Poland
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Centrum för neurologi
Stockholm, Sweden
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City Hospital No. 40 Kurortny District
Saint Petersburg, Russia
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Clinical Best Solutions
Warsaw, Poland
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Communal Non-Profit Enterprise "Ternopil Regional Clinical Psychoneurological Hospital" of Ternopil Regional Council, Department of Neurology #1
Ternopil, Ukraine
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Eginition Hospital, Athens University Medical School
Athens, Greece
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General University Hospital of Larissa
Larissa, Greece
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Generała Jarosława Dąbrowskiego
Oświęcim, Poland
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Gregorio Marañón General University Hospital
Madrid, Spain
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Hospital Clínico San Carlos
Madrid, Spain
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Hospital Universitario de Cruces
Bilbao, Spain
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Hospital Universitario y Politécnico La Fe
Valencia, Spain
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Hospital del Mar
Barcelona, Spain
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Hôpital Pasteur - CHU de Nice
Nice, France
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Hôpital Roger Salengro
Lille, France
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LLC "Center of socially significant diseases"
Saint Petersburg, Russia
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Le Centre hospitalier universitaire de Poitiers
Poitiers, France
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Lviv Regional Clinical Hospital
Lviv, Ukraine
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NOVI-MED
Ksawerów, Poland
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NZOZ Neuro-Kard
Poznan, Poland
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NZOZ Neuro-Med
Lublin, Poland
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Nzoz Neuro-Medic
Katowice, Poland
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Perm Regional Clinical Hospital
Perm, Russia
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Private Clinic ELPIS
Volos, Greece
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Rivne Regional Specialized Dispensary for Radiation Protection of the Population Municipal Enterprise
Rivne, Ukraine
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Sahlgrenska University Hospital
Gothenburg, Sweden
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Salutem Medical Center
Vinnytsia, Ukraine
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Service de Neurologie Hôpital Henri-Mondor
Créteil, France
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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.
- One-Time CAR-T infusion tested against progressive MS
- Can engineered immune cells tame autoimmune diseases?
- Can a blood pressure pill slow MS disability?
- Can an Iron-Based dye reveal hidden inflammation in progressive MS?
- Could a simple injection replace an IV for MS treatment?
- Could a common supplement fight fatigue in progressive MS?