Table 2

Inclusion and exclusion criteria

Inclusion criteria	Exclusion criteria
Patients diagnosed with a laboratory-supported, clinically ‘probable’ or ‘definite’ ALS according to the Revised El Escorial criteria. Sporadic ALS. ALS phenotypes: classic or bulbar. Female or male patients aged between 18 and 80 years old. Disease duration from symptom onset no longer than 18 months at the screening visit. Patients treated with a stable dose of riluzole (100 mg/day) for at least 30 days prior to screening. Patients with a weight of >50 kg and a BMI of ≥18. Patients with an FVC ≥65% predicted normal value for gender, height and age at the screening visit. Patients able and willing to comply with study procedures as per protocol. Patients able to understand and capable of providing informed consent at screening visit prior to any protocol-specific procedures. Use of highly effective contraception for both men and women.	Prior use of colchicine. Prior allergy/sensitivity to colchicine. Receiving colchicine or other anti-inflammatory drugs (such as corticosteroids, methotrexate, antineoplastic, interleukin 1–1b antagonist, tumor necrosis factor-alpha inhibitor). Receiving food or comedications, such as strong–moderate cytochrome P450 3A4 inhibitors that will result in elevated plasma levels of colchicine. Inflammatory disorders (systemic lupus erythematosus, rheumatoid arthritis and connective tissue disorder), chronic infections (HIV and hepatitis B or C infections) or significant history of malignancy. Severe renal (estimated Glomerular Filtration Rate <30 mL/min/1.73 m²) or liver failure or liver aminotransferase (aspartate transaminase/ alanine transaminase >2× upper limit of normal). Existing blood dyscrasia (eg, myelodysplasia). White blood cells <4 x 10⁹/L, platelets count of <100 x 10⁹/L and hematocrit level of <30%. Severe comorbidities (heart, renal and liver failures), autoimmune diseases or any type of interstitial lung disease. Patients who underwent non-invasive ventilation, tracheotomy and/or gastrostomy. Women who are pregnant or breastfeeding. Participation in pharmacological studies within the last 30 days before screening. Patients with the following ALS phenotypes: flail arm, flail leg, UMN-p, respiratory PLS and progressive muscular atrophy. Patients with familial ALS defined as the presence of at least one first-degree family member (parents/son/daughter/brother/sister) affected by ALS. Patients with known pathogenic mutations (SOD1, TARDBP, FUS and C9ORF72).

Inclusion criteria

Exclusion criteria

Patients diagnosed with a laboratory-supported, clinically ‘probable’ or ‘definite’ ALS according to the Revised El Escorial criteria.
Sporadic ALS.
ALS phenotypes: classic or bulbar.
Female or male patients aged between 18 and 80 years old.
Disease duration from symptom onset no longer than 18 months at the screening visit.
Patients treated with a stable dose of riluzole (100 mg/day) for at least 30 days prior to screening.
Patients with a weight of >50 kg and a BMI of ≥18.
Patients with an FVC ≥65% predicted normal value for gender, height and age at the screening visit.
Patients able and willing to comply with study procedures as per protocol.
Patients able to understand and capable of providing informed consent at screening visit prior to any protocol-specific procedures.
Use of highly effective contraception for both men and women.

Prior use of colchicine.
Prior allergy/sensitivity to colchicine.
Receiving colchicine or other anti-inflammatory drugs (such as corticosteroids, methotrexate, antineoplastic, interleukin 1–1b antagonist, tumor necrosis factor-alpha inhibitor).
Receiving food or comedications, such as strong–moderate cytochrome P450 3A4 inhibitors that will result in elevated plasma levels of colchicine.
Inflammatory disorders (systemic lupus erythematosus, rheumatoid arthritis and connective tissue disorder), chronic infections (HIV and hepatitis B or C infections) or significant history of malignancy.
Severe renal (estimated Glomerular Filtration Rate <30 mL/min/1.73 m²) or liver failure or liver aminotransferase (aspartate transaminase/ alanine transaminase >2× upper limit of normal).
Existing blood dyscrasia (eg, myelodysplasia).
White blood cells <4 x 10⁹/L, platelets count of <100 x 10⁹/L and hematocrit level of <30%.
Severe comorbidities (heart, renal and liver failures), autoimmune diseases or any type of interstitial lung disease.
Patients who underwent non-invasive ventilation, tracheotomy and/or gastrostomy.
Women who are pregnant or breastfeeding.
Participation in pharmacological studies within the last 30 days before screening.
Patients with the following ALS phenotypes: flail arm, flail leg, UMN-p, respiratory PLS and progressive muscular atrophy.
Patients with familial ALS defined as the presence of at least one first-degree family member (parents/son/daughter/brother/sister) affected by ALS.
Patients with known pathogenic mutations (SOD1, TARDBP, FUS and C9ORF72).

ALS, amyotrophic lateral sclerosis; BMI, body mass index; FVC, forced vital capacity; UMN-p, upper motor neuron predominant; PLS, primary lateral sclerosis.