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Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis
Sponsor: AB Science
Summary
To evaluate the efficacy and safety of oral masitinib versus placebo in the treatment of patients with primary progressive or secondary progressive multiple sclerosis without relapse.
Official title: A 96-Week, Prospective, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg/kg/Day Versus Placebo in the Treatment of Patients With Primary Progressive or Secondary Progressive Multiple Sclerosis Without Relapse
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
800
Start Date
2022-06-28
Completion Date
2028-12
Last Updated
2025-09-12
Healthy Volunteers
No
Conditions
Interventions
Placebo
treatment per os
Masitinib (4.5)
Masitinib (titration to 4.5 mg/kg/day)
Locations (37)
Service de Neurologie Hôpital Henri-Mondor
Créteil, France
Hôpital Roger Salengro
Lille, France
Hôpital Pasteur - CHU de Nice
Nice, France
Centre Hospitalier Universitaire Nimes - Service de Neurologie
Nîmes, France
Centre hospitalier intercommunal de Poissy-Saint-Germain-en-Laye
Poissy, France
Le Centre hospitalier universitaire de Poitiers
Poitiers, France
Centre Hospitalier Universitaire de Rouen
Rouen, France
Centre Hospitalier Universitaire de Strasbourg
Strasbourg, France
Centre Hospitalier Universitaire Toulouse
Toulouse, France
Athens Naval Hospital
Athens, Greece
Eginition Hospital, Athens University Medical School
Athens, Greece
General University Hospital of Larissa
Larissa, Greece
AHEPA University Hospital, Aristotle University of Thessaloniki
Thessaloniki, Greece
Private Clinic ELPIS
Volos, Greece
Azienda Ospedaliero Universitaria Policlinico "G.Rodolico -San Marco"
Catania, Italy
Nzoz Neuro-Medic
Katowice, Poland
NOVI-MED
Ksawerów, Poland
Centrum Neurologii Krzysztof Selmaj
Lodz, Poland
NZOZ Neuro-Med
Lublin, Poland
Generała Jarosława Dąbrowskiego
Oświęcim, Poland
NZOZ Neuro-Kard
Poznan, Poland
Clinical Best Solutions
Warsaw, Poland
State Budgetary Institution of Health of the City of Moscow City Polyclinic #2
Moscow, Russia
Perm Regional Clinical Hospital
Perm, Russia
City Hospital No. 40 Kurortny District
Saint Petersburg, Russia
LLC "Center of socially significant diseases"
Saint Petersburg, Russia
Hospital del Mar
Barcelona, Spain
Hospital Universitario de Cruces
Bilbao, Spain
Gregorio Marañón General University Hospital
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Spain
Sahlgrenska University Hospital
Gothenburg, Sweden
Centrum för neurologi
Stockholm, Sweden
Lviv Regional Clinical Hospital
Lviv, Ukraine
Rivne Regional Specialized Dispensary for Radiation Protection of the Population Municipal Enterprise
Rivne, Ukraine
Communal Non-Profit Enterprise "Ternopil Regional Clinical Psychoneurological Hospital" of Ternopil Regional Council, Department of Neurology #1
Ternopil, Ukraine
Salutem Medical Center
Vinnytsia, Ukraine