RecruitingPhase 3NCT03127267

Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients

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)

Sponsor

AB Science

Enrollment

495 participants

Start Date

Feb 2, 2021

Study Type

INTERVENTIONAL

Conditions

Amyotrophic Lateral Sclerosis

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).

Eligibility

Min Age: 18 YearsMax Age: 81 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Masitinib (4.5), a drug called Masitinib (6.0), and others for people with amyotrophic lateral sclerosis. The study is currently recruiting participants at 56 locations. People eligible for this study include aged 18 Years to 81 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMasitinib (6.0)

Masitinib (titration to 6.0 mg/kg/day)

DRUGRiluzole

Riluzole 50 mg tablet, treatment per os

DRUGPlacebo

treatment per os

DRUGMasitinib (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

Malmö, 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

View Full Details on ClinicalTrials.gov

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NCT03127267

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Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(56)

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