AuthorisedTherapeutic confirmatory (Phase III)Interventional

Sustained-release oral morphine to alleviate persistent dyspnea in patients with chronic respiratory insufficiency due to amyotrophic lateral sclerosis outside the administration of ventilatory assistance: prospective multicenter randomized, placebo-controlled study, parallel arms. (OPIDYS-ALS).

This study, called OPIDYS-ALS, is for people with Motor Neurone Disease (ALS) who have trouble breathing but are not using a breathing machine. It will investigate if a slow-release morphine tablet can help ease the discomfort of breathlessness. Half of the participants will receive the morphine, and the other half will receive a dummy tablet (placebo), so researchers can compare the effects. The main goal is to see if morphine reduces how unpleasant breathlessness feels after one week and then again after four weeks. Researchers will also look at how morphine affects pain, sleep, and overall quality of life for patients and their caregivers.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

160

Start

13 Feb 2026

patients with chronic respiratory insufficiency due to amyotrophic lateral sclerosis.

What is this study about?

This research study, called OPIDYS-ALS, is looking for a better way to help people who have Motor Neurone Disease (ALS) and also experience ongoing breathing difficulties. This can be a very challenging symptom, and doctors are always searching for safe and effective treatments to improve comfort.

The study wants to find out if a specific type of morphine tablet, designed to release slowly over time, can make breathing feel less difficult for people with ALS who aren't currently using a breathing machine. Morphine is a pain-relieving medicine, but it can also help to ease breathlessness. Scientists want to properly test this to see if it makes a real difference to people's daily lives and how they feel overall.

To do this fairly, some participants will receive the morphine tablet, while others will receive a dummy tablet (called a placebo). This is a common way to test new treatments, as it helps researchers be sure that any changes observed are due to the medication itself and not other factors. The study will look closely at how breathlessness changes, as well as checking on pain, sleep, and general well-being for both the patient and their closest caregiver.

Key takeaways

Tests if slow-release morphine helps breathlessness in ALS.
Compares morphine to a dummy tablet (placebo).
Focuses on improving comfort and quality of life.
For adults with ALS and breathing difficulties, not on a breathing machine.
Participation lasts about four weeks.
Caregivers' well-being is also considered.

Who may be eligible?

This study is looking for adults aged 18 and over, regardless of whether they are male or female. You would need to have been diagnosed with Motor Neurone Disease (ALS) and be experiencing ongoing problems with your breathing because of it. Importantly, you should not be using a breathing machine (ventilator) to help you breathe, at least not for the main part of your day.

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.

Are you 18 years old or older?
Do you have a diagnosis of Motor Neurone Disease (ALS)?
Are you currently experiencing ongoing breathing difficulties due to your ALS?
Are you NOT currently using a breathing machine (ventilator) for most of the day?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the slow-release morphine tablets or dummy tablets to take regularly. You won't know which one you're receiving, and neither will your doctor, which helps to keep the study fair. You'll need to keep track of how your breathing feels and any other symptoms over time. You'll have several visits or check-ins with the study team, likely at the start, after one week, and again after four weeks. During these visits, you'll answer questions about your breathing, pain, sleep, and general well-being. The study will also be looking at how the treatment might affect you, including any side effects. Your closest informal caregiver may also be asked to complete some questionnaires about their own well-being. The total duration of active participation is four weeks.

Potential risks and benefits

Participating in this study might offer a potential benefit by helping to reduce your breathlessness and improve your comfort and quality of life. However, like all medications, the morphine tablets may have side effects, such as constipation, drowsiness, or changes in your breathing. The dummy tablets have no active ingredients, so they shouldn't cause side effects, but also won't offer any direct benefit for breathlessness. The study team will closely monitor you for any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What is Motor Neurone Disease (ALS)?

Motor Neurone Disease, or ALS, is a condition that affects nerves in the brain and spinal cord, leading to muscle weakness and problems with movement, speech, and breathing.

What does 'chronic respiratory insufficiency' mean?

This means you have ongoing breathing difficulties because your lungs aren't working as well as they should, due to your ALS.

What is a 'placebo'?

A placebo is a dummy tablet that looks exactly like the real medicine but contains no active drug. It helps researchers compare the true effects of the medicine.

Will I know if I'm getting the real medicine?

No, neither you nor your study doctor will know whether you are receiving the morphine or the placebo. This is called a 'blinded' study and helps ensure fair results.

What if I feel unwell during the study?

The study team will monitor you closely, and you should tell them immediately if you experience any new or worsening symptoms, or feel unwell at any point.