Study of morphine to relieve shortness of breath in patients with amyotrophic lateral sclerosis who have breathing problems

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What is this study about?

This study examines amyotrophic lateral sclerosis, a disease that affects nerve cells in the brain and spinal cord, leading to muscle weakness and breathing problems. Patients with this condition may develop chronic respiratory insufficiency, which means their lungs cannot work properly on their own, and they often need help breathing through a mask at night. Many of these patients experience shortness of breath, called dyspnea, during the day when they are not using their breathing support device. This feeling of not getting enough air can be very uncomfortable and distressing. The treatment being tested is morphine sulfate, a pain medicine that will be given as prolonged-release tablets by mouth, meaning the medicine is released slowly over time. Some patients will receive morphine sulfate tablets while others will receive placebo tablets.

The purpose of this study is to find out whether morphine sulfate can reduce the unpleasantness of the worst episode of shortness of breath that patients experience during a day, measured four weeks after starting the study. The study will also look at other effects of the treatment, such as changes in how patients describe their shortness of breath, how anxious they feel about their breathing, how much time they spend using their breathing machine each day, their pain levels, their overall quality of life, and how well they sleep. The study will also examine how the treatment affects the patient’s closest family member or caregiver, including their anxiety levels and the burden they feel from providing care.

Patients who take part in this study will be randomly assigned to receive either morphine sulfate or placebo tablets for a period of several weeks. Throughout the study, patients will be asked to rate their shortness of breath and answer questions about their symptoms, quality of life, and sleep. Their breathing will be monitored, including measurements of breathing rate, oxygen levels, and blood gases when they are not using their breathing support. The study will also track any side effects that occur, with particular attention to constipation, which can be caused by morphine. The treatment period will last up to 77 days, with a maximum daily dose of 30 milligrams and a total dose of up to 2220 milligrams over the entire treatment period.

1 Initial treatment phase

Upon joining the study, you will be randomly assigned to receive either morphine sulfate tablets or placebo tablets. Morphine sulfate is a pain and breathing discomfort relief medication. A placebo is an inactive tablet that looks identical but contains no active medication.

You will take the assigned tablets by mouth. The tablets are designed to release the medication slowly over time, which is called sustained-release formulation.

You will continue taking the tablets daily throughout the study period.

2 First assessment at day 7

Seven days after starting the treatment, an assessment will be conducted to evaluate changes in your breathing discomfort.

You will be asked to rate the unpleasantness of the worst episode of breathing difficulty (also called dyspnea) you experienced in the previous 24 hours. This rating will be done using a numerical scale.

Additional evaluations will be performed to assess how the treatment affects your breathing discomfort and overall well-being.

3 Ongoing monitoring throughout the study

During the study period, various assessments will be conducted at scheduled intervals.

You will be asked to describe your breathing discomfort using specific questionnaires designed for individuals with your condition.

The time you spend daily using your mechanical ventilator (the device that assists your breathing at night) will be recorded.

Your breathing rate, oxygen levels in your blood, and blood gas measurements will be checked while you are breathing without ventilator assistance.

You will be asked to rate any pain you experience using a numerical scale from 0 to 10.

Your overall quality of life will be evaluated using standardized questionnaires.

Your sleep quality will be assessed using a specific questionnaire.

Any side effects or unwanted reactions to the treatment will be monitored and recorded according to standard safety guidelines.

Specific attention will be given to monitoring for constipation, which is a common side effect of morphine-type medications.

4 Final assessment at four weeks

Four weeks after starting the treatment, a final comprehensive assessment will be conducted.

You will again rate the unpleasantness of the worst episode of breathing difficulty you experienced in the previous 24 hours.

All other measurements and questionnaires completed during the study will be repeated to evaluate the overall effect of the treatment.

This final assessment marks the completion of your participation in the treatment phase of the study.

Who Can Join the Study?

You must be over 18 years old
You must have a confirmed diagnosis of amyotrophic lateral sclerosis, which is a disease that affects the nerves controlling muscles, regardless of what type you have or how advanced it is
You must have chronic respiratory insufficiency, which means your lungs have ongoing difficulty providing enough oxygen to your body
You must be using home nocturnal non-invasive mask ventilation, which is a breathing machine with a mask that you wear at night to help you breathe, for at least 6 hours each night for 3 months or longer
You must experience dyspnea, which means difficulty breathing or shortness of breath, during the day when you are not using the breathing machine, either when resting or doing minimal activity
Your difficulty breathing must be rated at 2 or more on a scale that measures how unpleasant your breathing discomfort feels
You must be affiliated with a social security system
You must be able to understand the information provided about the study
You must sign an informed consent form before participating in the study

Who Cannot Join the Study?

No exclusion criteria have been specified for this clinical trial in the available information.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Hopital Beaujon	Clichy	France
Cehyxt Hdrpsznbznv Uugzhldvmiseg Dc Dncdi	Dijon	France
Bnlwpcxe Upglrkajpy Hcpumzke Cnpqke	Besançon	France
Ckyn Dn Nijhk	Vandoeuvre Les Nancy	France
Crlsaw Hbohcxulykb Rznejoka Dzfbogztqbsuwi	Angers	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	27.02.2026

Trial locations

Investigated drugs:

Morphine Sulfate

Morphine is a pain medication that also helps reduce shortness of breath. In this study, it is given as a sustained-release oral pill, which means the medication is released slowly over time in your body. The purpose is to test whether it can help reduce the unpleasant feeling of difficulty breathing in patients with breathing problems caused by amyotrophic lateral sclerosis.

Amyotrophic Lateral Sclerosis – Amyotrophic lateral sclerosis is a progressive disease of the nervous system that affects nerve cells in the brain and spinal cord. The disease causes the gradual breakdown and death of nerve cells that control voluntary muscle movement. As the condition progresses, patients experience increasing muscle weakness and loss of muscle control throughout the body. This leads to difficulties with walking, speaking, swallowing, and breathing. Over time, the muscles responsible for breathing become weaker, resulting in chronic respiratory insufficiency. Patients eventually require mechanical ventilation support to assist with breathing.

Chronic Respiratory Insufficiency – Chronic respiratory insufficiency is a long-term condition where the lungs cannot adequately provide oxygen to the body or remove carbon dioxide from the blood. This condition develops gradually as the respiratory system progressively fails to maintain normal breathing function. Patients experience persistent shortness of breath and difficulty breathing that worsens over time. The condition can result from various underlying diseases that affect the lungs, airways, or the muscles involved in breathing. As it progresses, patients may require supplemental oxygen or mechanical ventilation to support their breathing.

Dyspnea – Dyspnea is the medical term for shortness of breath or difficulty breathing that causes discomfort or distress. It is characterized by an unpleasant sensation of breathing difficulty that can vary in intensity. Patients may describe it as feeling breathless, suffocated, or unable to get enough air. The sensation can occur during physical activity or even at rest, depending on the underlying cause and severity. Dyspnea often causes anxiety and can significantly impact daily activities and quality of life.

Trial ID:

2025-522546-52-00

Protocol code:

APHP 230842

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of morphine to relieve shortness of breath in patients with amyotrophic lateral sclerosis who have breathing problems

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