Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- ALSFRS-R — 48 weeks
Change in Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)-Revised.
Trial sites (56)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
Other trials for the same condition
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 Italy