Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients
NCT ID: NCT03127267
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
495 participants
INTERVENTIONAL
2021-02-02
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Masitinib (4.5) & Riluzole
Participants receive masitinib (3.0 mg/kg/day), given orally twice daily, with a dose escalation to 4.5 mg/kg/day after 4 weeks of treatment. Each ascending dose titration is subjected to a safety control. Masitinib will be administered as an add-on to riluzole at 50 mg b.i.d
Riluzole
Riluzole 50 mg tablet, treatment per os
Masitinib (4.5)
Masitinib (titration to 4.5 mg/kg/day)
Masitinib (6.0) & Riluzole
Participants receive masitinib (3.0 mg/kg/day), given orally twice daily, with a dose escalation to 4.5 mg/kg/day after 4 weeks of treatment, followed by dose escalation to 6.0 mg/kg/day after 4 weeks of treatment. Each ascending dose titration is subjected to a safety control. Masitinib will be administered as an add-on to riluzole at 50 mg b.i.d.
Masitinib (6.0)
Masitinib (titration to 6.0 mg/kg/day)
Riluzole
Riluzole 50 mg tablet, treatment per os
Placebo & Riluzole
Participants receive a matched dose placebo, given orally twice daily, in combination with riluzole at 50 mg b.i.d.
Riluzole
Riluzole 50 mg tablet, treatment per os
Placebo
treatment per os
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* Patient with a FVC \< 60% predicted normal value for gender, height, and age at screening and baseline
* Pregnant, or nursing female patient
18 Years
81 Years
ALL
No
Sponsors
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AB Science
INDUSTRY
Responsible Party
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Principal Investigators
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Albert Ludolph, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology, University of Ulm, Germany
Locations
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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 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
University Hospital Maggiore della Carita
Novara, , Italy
Azienda Ospedale-Università Padova
Padua, , 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
Countries
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Central Contacts
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References
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Latham BD, Oskin DS, Crouch RD, Vergne MJ, Jackson KD. Cytochromes P450 2C8 and 3A Catalyze the Metabolic Activation of the Tyrosine Kinase Inhibitor Masitinib. Chem Res Toxicol. 2022 Sep 19;35(9):1467-1481. doi: 10.1021/acs.chemrestox.2c00057. Epub 2022 Sep 1.
Other Identifiers
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AB19001
Identifier Type: -
Identifier Source: org_study_id
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