What this study is
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).
What's being tested
- Masitinib (6.0)
Intervention · DRUG
Masitinib (titration to 6.0 mg/kg/day)
- Riluzole
Intervention · DRUG
Riluzole 50 mg tablet, treatment per os
- Placebo
Intervention · DRUG
treatment per os
- Masitinib (4.5)
Intervention · DRUG
Masitinib (titration to 4.5 mg/kg/day)
Study details
- 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)
- Sponsor
- AB Science
- Conditions
- Amyotrophic Lateral Sclerosis
- Enrolling
- 495 people
- Starts
- 2021-02-02
- Est. completion
- 2027-12
- Design
- Double-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 81 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Patients diagnosed with laboratory supported probable, clinically probable or definite ALS according to the World Federation of Neurology Revised El Escorial criteria
- Patient with a familial or sporadic ALS
- ALS disease duration from diagnosis no longer than 24 months at the screening visit
- Patient treated with a stable dose of riluzole (100 mg/day) for at least 12 weeks days prior to the baseline visit
- Patient with an ALSFRS-R score progression between onset of the disease and screening of > 0.3 per month, confirmed with an ALSFRS-R score progression of ≥ 1 point during a 12-week run-in period between screening and randomization.
- Patient with a score, at screening, of at least 26 overall, including a score of at least 3 on item #3 and at least 2 on each of the 12 ALSFRS-R individual component items and with a score, at randomization, of at least 2 on each of the 12 ALSFRS-R individual component items
You can't join if
- Patient with dementia or significant neurological, psychiatric, systemic or organic disease, uncontrolled or that may interfere with the conduct of the trial or its results
- Patient with a FVC < 60% predicted normal value for gender, height, and age at screening and baseline
- Pregnant, or nursing female patient
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (56)
56 openUniversity of Alabama at Birmingham
Birmingham, Alabama, United States
RecruitingUniversity of Southern California
Los Angeles, California, United States
RecruitingUniversity of Kentucky
Lexington, Kentucky, United States
RecruitingJohns Hopkins Medicine Brain Science Institute
Baltimore, Maryland, United States
RecruitingLahey Hospital and Medical Center
Burlington, Massachusetts, United States
RecruitingUniversity of Virginia Health System
Charlottesville, Virginia, United States
Recruiting
50 sites outside the US
University Hospital Leuven (UZ Leuven)
Leuven, Belgium
RecruitingBispebjerg Hospital
Copenhagen, Denmark
RecruitingCHU de Angers
Angers, France
RecruitingGroupe Hospitalier Pellegrin Tripode
Bordeaux, France
RecruitingHôpital neurologique Pierre Wertheimer
Bron, France
RecruitingCHU Gabriel Montpied
Clermont-Ferrand, France
RecruitingCHU de Lille - Hopital Roger Salengro
Lille, France
RecruitingCHU de Limoges - Hôpital Dupuytren
Limoges, France
RecruitingCHU de Marseille - Hôpital de la Timone
Marseille, France
RecruitingCHRU de Montpellier - Gui de Chauliac
Montpellier, France
RecruitingCHU de Nancy - Hopital Central
Nancy, France
RecruitingCHU Hôpital Pasteur Nice
Nice, France
RecruitingCHRU de Tours - Hopital Bretonneau
Tours, France
RecruitingDepartment of Neurology, University of Ulm
Ulm, Germany
Not yet recruitingAthens Naval Hospital
Athens, Greece
RecruitingEginition Hospital
Athens, Greece
RecruitingUniversity General Hospital of Larissa
Larissa, Greece
RecruitingGeneral University Hospital of Patras
Rio, Greece
RecruitingHadassah University Hospital
Jerusalem, Israel
RecruitingTel-Aviv Medical Center Hôpital Sourasky (ICHILOV)
Tel Aviv, Israel
RecruitingOspedale Civile Sant'Agostino - Estense
Baggiovara, Modena, Italy
RecruitingASST degli Spedali Civili di Brescia
Brescia, Italy
RecruitingCentro Clinico NeMO Fondazione Serena Onlus
Gussago, Italy
RecruitingClinico Nemo Center (Centro Clinico NeMO Milano)
Milan, Italy
RecruitingIRCCS Istituto Auxologico Italiano
Milan, Italy
RecruitingIstituti Clinici Scientifici Maugeri IRCCS
Milan, Italy
RecruitingSan Raffaele Hospital (Ospedale San Raffaele)
Milan, Italy
RecruitingUniversity Hospital Maggiore della Carita
Novara, Italy
RecruitingAzienda Ospedale-Università Padova
Padua, Italy
RecruitingIRCCS Mondino Foundation
Pavia, Italy
RecruitingUniversity Hospital in Turin (Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino)
Torino, Italy
RecruitingOslo University Hospital HF Ullevål
Oslo, Norway
RecruitingCentrum Medyczne Neuromed
Bydgoszcz, Poland
RecruitingHospital de Santa Maria
Lisbon, Portugal
RecruitingMoscow city clinical Hospital after V.M. Buyanov
Moscow, Russia
RecruitingScientific Practical Medical Center "Innovation and Health"
Novosibirsk, Russia
RecruitingClinical Centre of Serbia
Belgrade, Serbia
RecruitingKlinicni center Ljubljana
Ljubljana, Slovenia
RecruitingHospital General Universitario de Alicante
Alicante, Spain
RecruitingHospital Universitari de Bellvitge
Barcelona, Spain
RecruitingHospital Carlos III
Madrid, Spain
RecruitingHospital San Rafael
Madrid, Spain
RecruitingClinical Hospital Santiago de Compostela
Santiago de Compostela, Spain
RecruitingHospital Universitario y Politecnico La Fe
Valencia, Spain
RecruitingCentralsjukhuset Karlstad (Central Hospital Karlstad)
Karlstad, Sweden
RecruitingSkåne University Hospital
Malmo, Sweden
RecruitingNorrlands universitetssjukhus
Umeå, Sweden
RecruitingThe State Institution of Neurology, Psychiatry and Narcology of NAMS of Ukraine
Kharkiv, Ukraine
RecruitingMedical Center of LLC Medical Center Dopomoga Plus
Kyiv, Ukraine
RecruitingCommunal Non-Profit Enterprise of Lviv Regional Council, Lviv Regional Clinical Hospital, Neurological Department
Lviv, Ukraine
Recruiting
Study team
Sponsor
AB Science
Study ID AB19001
Principal investigator
Albert Ludolph, MD, PhD
Department of Neurology, University of Ulm, Germany
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.