NCT07813858Not yet recruitingPhase 2
Colchicine Effect on Amyotrophic Lateral Sclerosis Patients
A Randomized, Placebo-controlled, Multicenter, Clinical Trial of Colchicine in Amyotrophic Lateral Sclerosis
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 87 (estimated)
- First submitted
- 2 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- May 2028
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT07813858
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 87
- From Oct 2026 to the primary completion date, May 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation or treatment within any other interventional or drug-based clinical trial.
Other illness
- Severe renal insufficiency, documented bone marrow suppression, or significant hematological abnormalities.
Lab values
- 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).
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Clinico Nemo Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| CENTRO SLA, Ospedale Civile di Baggiovara, AOU Modena Coordinator of this site? Confirm its status | Modena | Italy | Unknown status |
| CENTRO SLA, AOU Università Degli Studi Della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| CENTRO SLA, AOU Maggiore Della Carità Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| CENTRO SLA, Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.