Actively Recruiting
Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients
Led by AB Science · Updated on 2025-09-12
495
Participants Needed
56
Research Sites
356 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with laboratory supported probable, clinically probable, or definite ALS according to the World Federation of Neurology Revised El Escorial criteria
- Have familial or sporadic ALS
- ALS disease duration from diagnosis no longer than 24 months at screening
- Treated with a stable dose of riluzole (100 mg/day) for at least 12 weeks before baseline
- ALSFRS-R score progression greater than 0.3 per month before screening and at least 1 point progression during a 12-week run-in period
- ALSFRS-R score at screening of at least 26 overall, with at least 3 on item #3 and at least 2 on each of the 12 individual items, and at least 2 on each item at randomization
You will not qualify if you...
- Dementia or significant neurological, psychiatric, systemic, or organic disease that is uncontrolled or may interfere with the trial
- Forced vital capacity less than 60% of predicted normal value for gender, height, and age at screening and baseline
- Pregnant or nursing female patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 56 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
University of Southern California
Los Angeles, California, United States, 90007
Actively Recruiting
3
University of Kentucky
Lexington, Kentucky, United States, 40506
Actively Recruiting
4
Johns Hopkins Medicine Brain Science Institute
Baltimore, Maryland, United States, 21205
Actively Recruiting
5
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
Actively Recruiting
6
University of Virginia Health System
Charlottesville, Virginia, United States, 22903
Actively Recruiting
7
University Hospital Leuven (UZ Leuven)
Leuven, Belgium
Actively Recruiting
8
Bispebjerg Hospital
Copenhagen, Denmark
Actively Recruiting
9
CHU de Angers
Angers, France
Actively Recruiting
10
Groupe Hospitalier Pellegrin Tripode
Bordeaux, France
Actively Recruiting
11
Hôpital neurologique Pierre Wertheimer
Bron, France
Actively Recruiting
12
CHU Gabriel Montpied
Clermont-Ferrand, France
Actively Recruiting
13
CHU de Lille - Hopital Roger Salengro
Lille, France
Actively Recruiting
14
CHU de Limoges - Hôpital Dupuytren
Limoges, France
Actively Recruiting
15
CHU de Marseille - Hôpital de la Timone
Marseille, France
Actively Recruiting
16
CHRU de Montpellier - Gui de Chauliac
Montpellier, France
Actively Recruiting
17
CHU de Nancy - Hopital Central
Nancy, France
Actively Recruiting
18
CHU Hôpital Pasteur Nice
Nice, France
Actively Recruiting
19
CHRU de Tours - Hopital Bretonneau
Tours, France
Actively Recruiting
20
Department of Neurology, University of Ulm
Ulm, Germany, 89081
Not Yet Recruiting
21
Athens Naval Hospital
Athens, Greece
Actively Recruiting
22
Eginition Hospital
Athens, Greece
Actively Recruiting
23
University General Hospital of Larissa
Larissa, Greece
Actively Recruiting
24
General University Hospital of Patras
Rio, Greece
Actively Recruiting
25
Hadassah University Hospital
Jerusalem, Israel
Actively Recruiting
26
Tel-Aviv Medical Center Hôpital Sourasky (ICHILOV)
Tel Aviv, Israel
Actively Recruiting
27
Ospedale Civile Sant'Agostino - Estense
Baggiovara, Modena, Italy
Actively Recruiting
28
ASST degli Spedali Civili di Brescia
Brescia, Italy
Actively Recruiting
29
Centro Clinico NeMO Fondazione Serena Onlus
Gussago, Italy
Actively Recruiting
30
Clinico Nemo Center (Centro Clinico NeMO Milano)
Milan, Italy
Actively Recruiting
31
IRCCS Istituto Auxologico Italiano
Milan, Italy
Actively Recruiting
32
Istituti Clinici Scientifici Maugeri IRCCS
Milan, Italy
Actively Recruiting
33
San Raffaele Hospital (Ospedale San Raffaele)
Milan, Italy
Actively Recruiting
34
University Hospital Maggiore della Carita
Novara, Italy
Actively Recruiting
35
Azienda Ospedale-Università Padova
Padova, Italy
Actively Recruiting
36
IRCCS Mondino Foundation
Pavia, Italy
Actively Recruiting
37
University Hospital in Turin (Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino)
Torino, Italy
Actively Recruiting
38
Oslo University Hospital HF Ullevål
Oslo, Norway
Actively Recruiting
39
Centrum Medyczne Neuromed
Bydgoszcz, Poland
Actively Recruiting
40
Hospital de Santa Maria
Lisbon, Portugal
Actively Recruiting
41
Moscow city clinical Hospital after V.M. Buyanov
Moscow, Russia
Actively Recruiting
42
Scientific Practical Medical Center "Innovation and Health"
Novosibirsk, Russia
Actively Recruiting
43
Clinical Centre of Serbia
Belgrade, Serbia
Actively Recruiting
44
Klinicni center Ljubljana
Ljubljana, Slovenia
Actively Recruiting
45
Hospital General Universitario de Alicante
Alicante, Spain
Actively Recruiting
46
Hospital Universitari de Bellvitge
Barcelona, Spain
Actively Recruiting
47
Hospital Carlos III
Madrid, Spain
Actively Recruiting
48
Hospital San Rafael
Madrid, Spain
Actively Recruiting
49
Clinical Hospital Santiago de Compostela
Santiago de Compostela, Spain
Actively Recruiting
50
Hospital Universitario y Politecnico La Fe
Valencia, Spain
Actively Recruiting
51
Centralsjukhuset Karlstad (Central Hospital Karlstad)
Karlstad, Sweden
Actively Recruiting
52
Skåne University Hospital
Malmö, Sweden
Actively Recruiting
53
Norrlands universitetssjukhus
Umeå, Sweden
Actively Recruiting
54
The State Institution of Neurology, Psychiatry and Narcology of NAMS of Ukraine
Kharkiv, Ukraine
Actively Recruiting
55
Medical Center of LLC Medical Center Dopomoga Plus
Kyiv, Ukraine
Actively Recruiting
56
Communal Non-Profit Enterprise of Lviv Regional Council, Lviv Regional Clinical Hospital, Neurological Department
Lviv, Ukraine
Actively Recruiting
Research Team
C
Clinical Study Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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