A RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, CLINICAL TRIAL OF COLCHICINE IN AMYOTROPHIC LATERAL SCLEROSIS (CO-ALS II)
Key facts
- Where
- Milan, Modena, Naples, Novara, Padova és Pavia, OlaszországSee the 6 sites
- Phase
- 2. fázis
Where in Olaszország
- Centro Clinico NemoMilan, OlaszországToborzás még nem indult
- AOU di Modena Nuovo Ospedale Civile S. Agostino Estense di Modena - Ospedale di BaggiovaraModena, OlaszországToborzás még nem indult
- Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi VanvitelliNaples, OlaszországToborzás még nem indult
- Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, OlaszországToborzás még nem indult
- Azienda Ospedaliera di PadovaPadova, OlaszországToborzás még nem indult
- Fondazione Istituto Neurologico Nazionale Casimiro MondinoPavia, OlaszországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Azienda Ospedaliero Universitaria Di Modena
- Trial code
- EU 2026-526460-20-00
- Record updated
- 2026. október 28.
- Original description
to determine whether colchicine, administered at a dosage of 0.005 mg/kg/day, can slow disease progression compared to placeboRead full original descriptionShow less
to determine whether colchicine, administered at a dosage of 0.005 mg/kg/day, can slow disease progression compared to placebo
Inclusion: 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.
Exclusion: 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; 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; 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; Women who are pregnant or breastfeeding; Patients with ALSFRS-R total score<28; Patients with invasive ventilation or non-invasive ventilation > 8 hours/day.