TrialBridgeNCT07813858
Colchicine Effect on Amyotrophic Lateral Sclerosis Patients
Not Yet Recruiting · Phase 2 · Azienda Ospedaliero-Universitaria di Modena · registry updated 2026-09-10
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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....
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.
Exclusion
- Concurrent participation or treatment within any other interventional or drug-based clinical trial.
- 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).
- Severe renal insufficiency, documented bone marrow suppression, or significant hematological abnormalities.
- 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.