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Clinical Trials in the USA / NCT03127267
Recruiting Phase 3

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

NCT03127267 · tracked via the Priya Life Science USA tracker
Sponsor
AB Science
Phase
Phase 3
Started
2021-02-02
Last updated
2025-09-12

Condition(s) studied

Amyotrophic Lateral Sclerosis

Investigational drug(s) / intervention(s)

Masitinib (6.0)RiluzolePlaceboMasitinib (4.5)

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)

Study 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

Sex
ALL
Min age
18 Years
Max age
81 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (56)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
University of Southern California Los Angeles California Recruiting
University of Kentucky Lexington Kentucky Recruiting
Johns Hopkins Medicine Brain Science Institute Baltimore Maryland Recruiting
Lahey Hospital and Medical Center Burlington Massachusetts Recruiting
University of Virginia Health System Charlottesville Virginia Recruiting
University Hospital Leuven (UZ Leuven) Leuven Belgium Recruiting
Bispebjerg Hospital Copenhagen Denmark Recruiting
CHU de Angers Angers France Recruiting
Groupe Hospitalier Pellegrin Tripode Bordeaux France Recruiting
Hôpital neurologique Pierre Wertheimer Bron France Recruiting
CHU Gabriel Montpied Clermont-Ferrand France Recruiting
CHU de Lille - Hopital Roger Salengro Lille France Recruiting
CHU de Limoges - Hôpital Dupuytren Limoges France Recruiting
CHU de Marseille - Hôpital de la Timone Marseille France Recruiting
CHRU de Montpellier - Gui de Chauliac Montpellier France Recruiting
CHU de Nancy - Hopital Central Nancy France Recruiting
CHU Hôpital Pasteur Nice Nice France Recruiting
CHRU de Tours - Hopital Bretonneau Tours France Recruiting
Department of Neurology, University of Ulm Ulm Germany Not Yet Recruiting
Athens Naval Hospital Athens Greece Recruiting
Eginition Hospital Athens Greece Recruiting
University General Hospital of Larissa Larissa Greece Recruiting
General University Hospital of Patras Rio Greece Recruiting
Hadassah University Hospital Jerusalem Israel Recruiting
Tel-Aviv Medical Center Hôpital Sourasky (ICHILOV) Tel Aviv Israel Recruiting
Ospedale Civile Sant'Agostino - Estense Baggiovara Modena Recruiting
ASST degli Spedali Civili di Brescia Brescia Italy Recruiting
Centro Clinico NeMO Fondazione Serena Onlus Gussago Italy Recruiting
Clinico Nemo Center (Centro Clinico NeMO Milano) Milan Italy Recruiting
IRCCS Istituto Auxologico Italiano Milan Italy Recruiting
Istituti Clinici Scientifici Maugeri IRCCS Milan Italy Recruiting
San Raffaele Hospital (Ospedale San Raffaele) Milan Italy Recruiting
University Hospital Maggiore della Carita Novara Italy Recruiting
Azienda Ospedale-Università Padova Padova Italy Recruiting
IRCCS Mondino Foundation Pavia Italy Recruiting
University Hospital in Turin (Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino) Torino Italy Recruiting
Oslo University Hospital HF Ullevål Oslo Norway Recruiting
Centrum Medyczne Neuromed Bydgoszcz Poland Recruiting
Hospital de Santa Maria Lisbon Portugal Recruiting

+ 16 more sites — see the full list on the official registry below.

More AB Science trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03127267 on ClinicalTrials.gov ↗ ← All trials in the USA