AuthorisedTherapeutic exploratory (Phase II)Interventional

A RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, CLINICAL TRIAL OF COLCHICINE IN AMYOTROPHIC LATERAL SCLEROSIS (CO-ALS II)

Amyotrophic lateral sclerosis (ALS) is the most common type of motor neurone disease (MND). It affects nerve cells in the brain and spine, causing muscles to weaken over time. Currently, there are very few treatments that can slow the condition down. This Phase II research study tests whether an established medicine called colchicine can help protect these nerve cells and slow the loss of physical abilities. Colchicine is already commonly used to treat other inflammatory conditions such as gout. During the first 30 weeks, participants will take either a 0.5 mg colchicine tablet or an identical dummy pill (placebo) once a day. Neither you nor your doctors will know which one you receive. After this, all participants are offered colchicine for a further 36 weeks. Doctors will track changes in muscle strength, breathing, and daily quality of life through regular hospital visits.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Azienda Ospedaliero Universitaria Di Modena

Enrolment target

Start

12 Aug 2026

AMYOTROPHIC LATERAL SCLEROSIS

What is this study about?

Amyotrophic lateral sclerosis (ALS) is a progressive condition that attacks the motor nerves responsible for controlling voluntary movement. In the UK, it is often referred to as motor neurone disease (MND). As these nerve cells break down, signals to the muscles are lost, leading to muscle wasting and weakness that can affect walking, speaking, swallowing, and breathing. Finding treatments that slow down this nerve damage is one of the most urgent priorities in neurological research.

This study, named CO-ALS II, is exploring whether a tablet called colchicine can help. Colchicine is an existing anti-inflammatory medication that has been safely prescribed for decades, mainly for painful joint conditions like gout. Laboratory research suggests that colchicine may help nerve cells handle stress better by reducing harmful inflammation and clearing away faulty proteins that build up inside motor neurones.

To find out if colchicine truly works for ALS, researchers need to compare it against a dummy tablet, known as a placebo. During the first 30 weeks, half of the volunteers will receive colchicine and the other half will take the placebo. Comparing the two groups allows scientists to see whether any slowdown in symptoms is really caused by the medicine rather than chance. In the second part of the trial, which lasts 36 weeks, every participant is offered colchicine so that no one misses out on the active treatment.

Throughout the study, doctors will regularly measure participants' everyday abilities, lung capacity, and overall well-being. If colchicine is shown to be effective, it could offer a widely accessible and affordable new treatment option to help people with ALS stay independent for longer.

Key takeaways

Tests whether colchicine, an existing anti-inflammatory pill, can slow the progression of ALS.
Open to adults aged 18 and older diagnosed with ALS (motor neurone disease).
Involves 30 weeks of comparing colchicine with a placebo, followed by 36 weeks where all participants receive colchicine.
Monitors your daily activities, breathing, muscle function, and quality of life at regular clinic visits.
Participation is entirely voluntary, and you may withdraw at any time without altering your standard care.

Who may be eligible?

This trial is open to adults aged 18 and over who have received a confirmed diagnosis of amyotrophic lateral sclerosis (ALS). Both men and women are eligible to take part.

Before you can join, the study doctors will carry out some initial health checks. These include reviewing your full medical history, checking how well your kidneys and liver are functioning with routine blood tests, and assessing your breathing and current symptoms to make sure taking part is safe for you.

Some people may not be able to participate. For example, if you have severe kidney or liver problems, you may be excluded because colchicine is processed by these organs. You may also be unable to join if you take certain medicines that interact dangerously with colchicine, or if you are pregnant or breastfeeding. The trial team will review your situation carefully before you enrol.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

You are aged 18 or older.
You have a confirmed medical diagnosis of amyotrophic lateral sclerosis (ALS).
You do not have severe kidney or liver disease.
You are able and willing to swallow a tablet once daily.
You can travel to the hospital clinic for regular check-ups over a 66-week period.

Answer every question to see your result.

What does participation involve?

Taking part in this study lasts for about 66 weeks (roughly 15 months) and is divided into two stages.

In the first stage (weeks 1 to 30), you will take one 0.5 mg tablet once a day. A computer system randomly decides whether you get colchicine or a placebo tablet. You will visit the hospital clinic regularly—roughly every 4 to 6 weeks—for standard health checks. These visits include completing a daily-living questionnaire (called the ALSFRS-R), simple breathing tests where you blow into a device, routine blood tests, and questions about your quality of life.

In the second stage (weeks 31 to 66), called the open-label extension, all participants receive daily colchicine tablets. You will continue to attend the hospital clinic every few months so the research team can monitor your physical function and safety until the study finishes.

Potential risks and benefits

There is no guarantee that taking colchicine will slow down your ALS or improve your symptoms. However, you will receive regular, detailed health check-ups from specialist doctors, and your participation will provide vital answers that could help other people with ALS in the future. Colchicine can cause side effects, most commonly digestive problems like diarrhoea, stomach cramps, nausea, or sickness. Less commonly, it can affect blood counts or muscle health, which is why regular blood tests are carried out. Joining the study is completely voluntary, and you are free to leave at any time without your regular NHS care being affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is a placebo and why is it used?

A placebo is an inactive tablet that looks and tastes identical to the real medicine. It helps scientists prove whether any changes in your health are truly caused by colchicine or by other factors.

Can I choose whether I receive colchicine or the placebo?

No. In the first 30 weeks, a computer decides at random, and neither you nor your doctor will know which pill you are taking. However, in the second stage (weeks 31 to 66), everyone is given colchicine.

Will taking part affect my current MND medications?

You will usually be able to continue your standard treatments (such as riluzole). The study team will check all your regular medicines beforehand to ensure there are no unsafe interactions.

What happens if I experience unpleasant side effects?

You should contact the trial team straight away. They can offer advice, prescribe medicines to ease tummy upset, lower your dose, or stop the study treatment if necessary.

Do I have to pay to take part in this study?

No. The study medication and all trial-related appointments and tests are provided free of charge. Many trials also offer help to cover your travel costs.