A RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, CLINICAL TRIAL OF COLCHICINE IN AMYOTROPHIC LATERAL SCLEROSIS (CO-ALS II)

AMYOTROPHIC LATERAL SCLEROSIS

Colchicine efficacy will be assessed by comparing the monthly decline in the ALSFRS-R score between the treatment and placebo groups over 30 weeks of treatment and 36 weeks of open-label extension

the average decline in ALSFRS-R scores in the two treatment arms from baseline to weeks 4, 8, 12, 18, 24, 30, 42, 54, and 66, change in the Rasch-Built Overall Amyotrophic Lateral Sclerosis Disability Scale (ROADS) scores in the two treatment arms from baseline to weeks 8, 18, 30, 42, 54, and 66., overall survival in the two treatment arms, defined as the time from randomization to death or tracheostomy, change in Forced vital capacity (FVC) in the two treatment arms from baseline to weeks 4, 8, 12, 18, 24, 30, 42, 54, and 66, change in quality of life, assessed using the ALS Assessment Questionnaire-40 (ALSAQ-40) questionnaire in the two treatment arms from baseline to week 30 and 66, changes in ALSFRS-R domain-specific subscores (e.g., bulbar and motor domains) in the two treatment arms from baseline to weeks 4, 8, 12, 18, 24, 30, 42, 54, and 66, difference in the monthly decline in ALSFRS-R scores (delta FS) in the two treatment arms from treatment initiation to 30 weeks after treatment initiation (end of treatment) compared to the delta FS in the period from onset (considering a score of 48 for each patient at onset) to treatment initiation

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