Low-dose colchicine to slow amyotrophic lateral sclerosis
Tests whether colchicine slows decline in adults with amyotrophic lateral sclerosis.
Plain-language title generated from the registry record
Registry title: Colchicine Effect on Amyotrophic Lateral Sclerosis Patients
Key facts
- Where
- Milan, Modena, Naples, Novara, and Pavia, ItalySee the 5 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07813858, who can take part
Where in Italy
- Centro Clinico NemoMilan, ItalyNo longer taking part
- CENTRO SLA, Ospedale Civile di Baggiovara, AOU ModenaModena, ItalyNo longer taking part
- CENTRO SLA, AOU Università Degli Studi Della Campania Luigi VanvitelliNaples, ItalyNo longer taking part
- CENTRO SLA, AOU Maggiore Della CaritàNovara, ItalyNo longer taking part
- CENTRO SLA, Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCSPavia, ItalyNo longer taking part
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
- NCT07813858
- Record updated
- 10 September 2026
- Original description
The goal of this clinical trial is to evaluate whether low-dose colchicine can slow disease progression in patients with amyotrophic lateral sclerosis (ALS), a progressive and fatal neurodegenerative disorder affecting motor neurons.Read full original descriptionShow less
A Randomized, Placebo-controlled, Multicenter, Clinical Trial of Colchicine in Amyotrophic Lateral Sclerosis
The goal of this clinical trial is to evaluate whether low-dose colchicine can slow disease progression in patients with amyotrophic lateral sclerosis (ALS), a progressive and fatal neurodegenerative disorder affecting motor neurons.
The study is designed to answer whether patients receiving colchicine show a slower decline in functional status, as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), over a 30-week double-blind treatment period compared to patients receiving placebo. Additional questions include whether colchicine has an effect on respiratory function, disability progression, quality of life, and overall survival.
Researchers will compare participants receiving colchicine at a dose of 0.005 mg/kg/day with those receiving placebo, both in addition to standard-of-care therapy with riluzole, to assess potential differences in disease progression.
Participants will be randomly assigned in a 2:1 ratio to colchicine or placebo. They will take the assigned study medication for 30 weeks during a double-blind phase and then continue into a 36-week open-label extension phase, during which all participants will receive colchicine while remaining blinded to their initial treatment assignment. Throughout the study, participants will undergo regular clinical evaluations, including assessments of motor and respiratory function, functional disability, and quality of life, for a total follow-up period of up to 66 weeks. Blood samples will also be collected to investigate biological markers of neurodegeneration and inflammation.
Inclusion: Patient age strictly between 18 and 80 years at the time of screening; Definitively established diagnosis of ALS (sporadic or familial) matching standardized clinical consensus parameters; Stable background regimen of European gold-standard Riluzole therapy maintained at a fixed dose of 100 mg/day for a minimum of 1 month prior to baseline randomization; BMI>17.5 Kg/m2; Sufficient respiratory capability, verified by an upright Forced Vital Capacity (FVC) >= 70% of predicted normal values at screening (highest value of three sequential tests); Patient must display full cognitive and communicative capacity to provide written, personally signed Independent Ethics Committee-approved Informed Consent prior to initiation of any protocolized procedures; Use of highly effective contraception both for males and females.
Exclusion: Concurrent participation or treatment within any other interventional or drug-based clinical trial; Severe renal insufficiency, documented bone marrow suppression, or significant hematological abnormalities; Clinically significant hepatic impairment (defined as baseline serum transaminases AST or ALT exceeding 3x Upper Limit of Normal [ULN], or total bilirubin exceeding 2x ULN); Known hypersensitivity or systemic intolerance to colchicine or any of the manufacturing excipients (lactose, sucrose, magnesium stearate, arabic gum); Pregnancy, active lactation, or unwillingness of fertile male/female subjects to strictly comply with highly effective double-barrier contraception regimens throughout the study and for 100 days post-final dose.