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Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients
Sponsor: AB Science
Summary
The objective is to compare the efficacy and safety of masitinib in combination with riluzole versus matched placebo in combination with riluzole for the treatment of Amyotrophic Lateral Sclerosis (ALS).
Official title: Phase 3 Study to Compare the Efficacy and Safety of Masitinib in Combination With Riluzole Versus Placebo in Combination With Riluzole in the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)
Key Details
Gender
All
Age Range
18 Years - 81 Years
Study Type
INTERVENTIONAL
Enrollment
495
Start Date
2021-02-02
Completion Date
2027-12
Last Updated
2025-09-12
Healthy Volunteers
No
Conditions
Interventions
Masitinib (6.0)
Masitinib (titration to 6.0 mg/kg/day)
Riluzole
Riluzole 50 mg tablet, treatment per os
Placebo
treatment per os
Masitinib (4.5)
Masitinib (titration to 4.5 mg/kg/day)
Locations (56)
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Southern California
Los Angeles, California, United States
University of Kentucky
Lexington, Kentucky, United States
Johns Hopkins Medicine Brain Science Institute
Baltimore, Maryland, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
University of Virginia Health System
Charlottesville, Virginia, United States
University Hospital Leuven (UZ Leuven)
Leuven, Belgium
Bispebjerg Hospital
Copenhagen, Denmark
CHU de Angers
Angers, France
Groupe Hospitalier Pellegrin Tripode
Bordeaux, France
Hôpital neurologique Pierre Wertheimer
Bron, France
CHU Gabriel Montpied
Clermont-Ferrand, France
CHU de Lille - Hopital Roger Salengro
Lille, France
CHU de Limoges - Hôpital Dupuytren
Limoges, France
CHU de Marseille - Hôpital de la Timone
Marseille, France
CHRU de Montpellier - Gui de Chauliac
Montpellier, France
CHU de Nancy - Hopital Central
Nancy, France
CHU Hôpital Pasteur Nice
Nice, France
CHRU de Tours - Hopital Bretonneau
Tours, France
Department of Neurology, University of Ulm
Ulm, Germany
Athens Naval Hospital
Athens, Greece
Eginition Hospital
Athens, Greece
University General Hospital of Larissa
Larissa, Greece
General University Hospital of Patras
Rio, Greece
Hadassah University Hospital
Jerusalem, Israel
Tel-Aviv Medical Center Hôpital Sourasky (ICHILOV)
Tel Aviv, Israel
Ospedale Civile Sant'Agostino - Estense
Baggiovara, Modena, Italy
ASST degli Spedali Civili di Brescia
Brescia, Italy
Centro Clinico NeMO Fondazione Serena Onlus
Gussago, Italy
Clinico Nemo Center (Centro Clinico NeMO Milano)
Milan, Italy
IRCCS Istituto Auxologico Italiano
Milan, Italy
Istituti Clinici Scientifici Maugeri IRCCS
Milan, Italy
San Raffaele Hospital (Ospedale San Raffaele)
Milan, Italy
University Hospital Maggiore della Carita
Novara, Italy
Azienda Ospedale-Università Padova
Padova, Italy
IRCCS Mondino Foundation
Pavia, Italy
University Hospital in Turin (Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino)
Torino, Italy
Oslo University Hospital HF Ullevål
Oslo, Norway
Centrum Medyczne Neuromed
Bydgoszcz, Poland
Hospital de Santa Maria
Lisbon, Portugal
Moscow city clinical Hospital after V.M. Buyanov
Moscow, Russia
Scientific Practical Medical Center "Innovation and Health"
Novosibirsk, Russia
Clinical Centre of Serbia
Belgrade, Serbia
Klinicni center Ljubljana
Ljubljana, Slovenia
Hospital General Universitario de Alicante
Alicante, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
Hospital Carlos III
Madrid, Spain
Hospital San Rafael
Madrid, Spain
Clinical Hospital Santiago de Compostela
Santiago de Compostela, Spain
Hospital Universitario y Politecnico La Fe
Valencia, Spain
Centralsjukhuset Karlstad (Central Hospital Karlstad)
Karlstad, Sweden
Skåne University Hospital
Malmo, Sweden
Norrlands universitetssjukhus
Umeå, Sweden
The State Institution of Neurology, Psychiatry and Narcology of NAMS of Ukraine
Kharkiv, Ukraine
Medical Center of LLC Medical Center Dopomoga Plus
Kyiv, Ukraine
Communal Non-Profit Enterprise of Lviv Regional Council, Lviv Regional Clinical Hospital, Neurological Department
Lviv, Ukraine