Study Purpose:
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).Study Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
Masitinib (6.0), Riluzole, Placebo, Masitinib (4.5)
Placebo:
Yes
Phase:
Phase 3
Study Chair(s)/Principal Investigator(s):
Albert Ludolph, MD, PhD, Department of Neurology, University of Ulm, Germany
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Clinical Study Coordinator / email hidden; JavaScript is required / +33(0)147200014
Full Study Summary:
Masitinib is a selective, oral tyrosine kinase inhibitor with neuroprotective capability demonstrated via numerous preclinical studies. Two of masitinib's main cellular targets are the mast cell and microglia cell. It is well-established that mast cells play a prominent role in neuroinflammatory processes. Microglia, resident immune cells of the central nervous system (CNS), also constitute an important source of neuroinflammatory mediators and may have fundamental roles in numerous neurodegenerative disorders. The development of masitinib in ALS is therefore based on the pharmacological action of masitinib in microglia cells and mast cells, thereby slowing microglial-related disease progression, reducing neuro-inflammation, and modulating the neuronal microenvironment in both central and peripheral nervous systems. This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group (two ascending dose titrations of masitinib and matching placebo), comparative study of oral masitinib in the treatment of patients with amyotrophic lateral sclerosis (ALS).
Study Sponsor:
AB Science
Estimated Enrollment:
495
Estimated Study Start Date:
02 / 02 / 2021
Estimated Study Completion Date:
12 / 01 / 2023
Posting Last Modified Date:
04 / 18 / 2023
Date Study Added to neals.org:
04 / 25 / 2017
Minimum Age:
18 Years
Maximum Age:
81 Years
Can participants use Riluzole?
Yes
Main inclusion criteria include:- 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
Main exclusion criteria include:
- 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
University of Alabama at Birmingham | Recruiting
Birmingham, Alabama
35294
United States
University of Southern California | Recruiting
Los Angeles, California
90007
United States
University of Kentucky | Recruiting
Lexington, Kentucky
40506
United States
Johns Hopkins Medicine Brain Science Institute | Recruiting
Baltimore, Maryland
21205
United States
Lahey Hospital and Medical Center | Recruiting
Burlington, Massachusetts
01805
United States
University of Virginia Health System | Recruiting
Charlottesville, Virginia
22903
United States
University Hospital Leuven (UZ Leuven) | Recruiting
Leuven
Belgium
Bispebjerg Hospital | Recruiting
Copenhagen
Denmark
CHU de Marseille - Hôpital de la Timone | Recruiting
Marseille
France
CHU Hôpital Pasteur Nice | Recruiting
Nice
France
CHU de Nancy - Hopital Central | Recruiting
Nancy
France
CHRU de Montpellier - Gui de Chauliac | Recruiting
Montpellier
France
CHRU de Tours - Hopital Bretonneau | Recruiting
Tours
France
CHU de Limoges - Hôpital Dupuytren | Recruiting
Limoges
France
CHU de Lille - Hopital Roger Salengro | Recruiting
Lille
France
CHU Gabriel Montpied | Recruiting
Clermont Ferrand
France
Hôpital neurologique Pierre Wertheimer | Recruiting
Bron
France
Groupe Hospitalier Pellegrin Tripode | Recruiting
Bordeaux
France
CHU de Angers | Recruiting
Angers
France
Department of Neurology, University of Ulm | Not yet recruiting
Ulm 89081
Germany
General University Hospital of Patras | Recruiting
Río
Greece
University General Hospital of Larissa | Recruiting
Larissa
Greece
Eginition Hospital | Recruiting
Athens
Greece
Athens Naval Hospital | Recruiting
Athens
Greece
Hadassah University Hospital | Recruiting
Jerusalem
Israel
Tel-Aviv Medical Center Hôpital Sourasky (ICHILOV) | Recruiting
Tel Aviv
Israel
University Hospital in Turin (Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino) | Recruiting
Torino
Italy
IRCCS Mondino Foundation | Recruiting
Pavia
Italy
Azienda Ospedale-Università Padova | Recruiting
Padova
Italy
University Hospital Maggiore della Carita | Recruiting
Novara
Italy
San Raffaele Hospital (Ospedale San Raffaele) | Recruiting
Milano
Italy
Istituti Clinici Scientifici Maugeri IRCCS | Recruiting
Milano
Italy
IRCCS Istituto Auxologico Italiano | Recruiting
Milano
Italy
Centro Clinico NeMO Fondazione Serena Onlus | Recruiting
Gussago
Italy
ASST degli Spedali Civili di Brescia | Recruiting
Brescia
Italy
Ospedale Civile Sant'Agostino - Estense | Recruiting
Baggiovara, Modena
Italy
Clinico Nemo Center (Centro Clinico NeMO Milano) | Recruiting
Milano
Italy
Oslo University Hospital HF Ullevål | Recruiting
Oslo
Norway
Centrum Medyczne Neuromed | Recruiting
Bydgoszcz
Poland
Hospital de Santa Maria | Recruiting
Lisboa
Portugal
Moscow city clinical Hospital after V.M. Buyanov | Recruiting
Moscow
Russian Federation
Scientific Practical Medical Center "Innovation and Health" | Recruiting
Novosibirsk
Russian Federation
Clinical Centre of Serbia | Recruiting
Belgrad
Serbia
Klinicni center Ljubljana | Recruiting
Ljubljana
Slovenia
Clinical Hospital Santiago de Compostela | Recruiting
Santiago De Compostela
Spain
Hospital Universitario y Politecnico La Fe | Recruiting
Valencia
Spain
Hospital General Universitario de Alicante | Recruiting
Alicante
Spain
Hospital San Rafael | Recruiting
Madrid
Spain
Hospital Carlos III | Recruiting
Madrid
Spain
Hospital Universitari de Bellvitge | Recruiting
Barcelona
Spain
Centralsjukhuset Karlstad (Central Hospital Karlstad) | Recruiting
Karlstad
Sweden
Skåne University Hospital | Recruiting
Malmö
Sweden
Norrlands universitetssjukhus | Recruiting
Umeå
Sweden
The State Institution of Neurology, Psychiatry and Narcology of NAMS of Ukraine | Recruiting
Kharkiv
Ukraine
Medical Center of LLC Medical Center Dopomoga Plus | Recruiting
Kyiv
Ukraine
Communal Non-Profit Enterprise of Lviv Regional Council, Lviv Regional Clinical Hospital, Neurological Department | Recruiting
Lviv
Ukraine