Colchicine for Amyotrophic Lateral Sclerosis

Exclusion Criteria

• •Prior use of Colchicine
• •Prior allergy/sensitivity to Colchicine
• •Receiving Colchicine or other anti-inflammatory drugs (such as corticosteroids, methotrexate, anti-neoplastic, Interleukin 1-1b antagonist, Tumor necrosis factor-alpha inhibitor)
• •Receiving food or co-medications such as strong-moderate cytochrome P450 3A4 inhibitors that will result in elevated plasma level of Colchicine
• •Inflammatory disorders (SLE, Rheumatoid arthritis, connective tissue disorder) or chronic infections (HIV, hepatitis B or C infection) or significant history of malignancy
• •Severe renal (eGFR\< 30ml/min/1.73m2), or liver failure or liver aminotransferase (ALT/AST \> 2x Upper limit of normal),
• •Existing blood dyscrasia (e.g., myelodysplasia)
• •White blood cells\<4,000/mm³, platelets count\<100,000/mm³, hematocrit\<30%
• •Severe comorbidities (heart, renal, liver failure), 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, progressive muscular atrophy.
• •Patients with familial ALS defined as 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, C9ORF72).