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

Prior treatment

• Prior use or prior allergy/sensitivity to colchicine
• Participation in other RCTs within the last 30 days before screening
• Chronic use of colchicine or other anti-inflammatory drugs (e.g. corticosteroids, methotrexate, IL1-1b antagonist, TNF-alpha inhibitor)
• Food or co-medications (e.g. strong CYP3A4 inhibitors) that will result in elevated plasma level of colchicine

Other illness

• Inflammatory/autoimmune disorders or chronic infections or malignancy
• Severe comorbidities (heart, renal, liver failure), autoimmune diseases or any type of interstitial lung disease, with severity determined at the investigator’s clinical judgment

Lab values

• Severe renal or liver failure, blood dyscrasia or white blood cells<4,000/mm³, platelets count<100,000/mm³, hematocrit<30%
• Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

Other

• Women who are pregnant or breastfeeding
• Patients with ALSFRS-R total score<28
• Patients with invasive ventilation or non-invasive ventilation > 8 hours/day

• Patients diagnosed with probable laboratory-supported, clinically probable, or definite ALS according to the Revised El Escorial criteria (Brooks, 2000) (both sporadic and familial forms)
• Female or male patients aged between 18 and 80 years old
• Disease duration from limb weakness or bulbar symptoms onset < or = 18 months at screening
• Stable dose of Riluzole at 50 mg bid for at least 30 days prior to screening
• BMI>17.5 Kg/m2
• FVC≥60% of the predicted normal value for gender, height, and age at screening
• Patients able to provide informed consent and willing to comply with study procedures
• Use of highly effective contraception both for males and females