The study evaluates the effects of two different Colchicine doses (0.01mg/kg/day or 0.005
mg/kg/day) compared to placebo in Amyotrophic Lateral Sclerosis (ALS) patients. Disease
progression as defined by changes in ALSFRS-r is the primary outcome measure. Other measures
of clinical progression and survival, together with safety and tolerability of Colchicine in
ALS patients will be assessed.
Phase:
Phase 2
Details
Lead Sponsor:
Azienda Ospedaliero-Universitaria di Modena
Collaborators:
Catholic University of the Sacred Heart IRCCS National Neurological Institute "C. Mondino" Foundation IRCCS San Raffaele Istituto Auxologico Italiano Istituto Di Ricerche Farmacologiche Mario Negri University of Bari University of Campania "Luigi Vanvitelli" University of Milan University of Modena and Reggio Emilia University of Padova University of Turin, Italy