Study on the Effect of Salbutamol on Walking Ability in Patients with ALS

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What is this study about?

This clinical trial is focused on studying the effects of a medication called salbutamol on individuals with Amyotrophic Lateral Sclerosis (ALS). ALS is a progressive neurological disease that affects nerve cells in the brain and spinal cord, leading to muscle weakness and difficulty in walking. The trial aims to evaluate whether salbutamol can improve walking capacity in patients who are still able to walk.

Participants in the study will receive either salbutamol or a placebo, which is a substance with no active medication. Salbutamol is administered as an oral solution, meaning it is taken by mouth in liquid form. The study will last for a period of six months, during which the effects of salbutamol on walking ability will be closely monitored. The main goal is to see if there is an improvement in the distance patients can walk in six minutes, a common test used to measure walking capacity.

The study is designed to provide valuable information on the potential benefits of salbutamol for people with ALS, specifically in terms of enhancing their ability to walk. This research could lead to new treatment options that help improve the quality of life for those living with this challenging condition.

1 joining the study

Upon joining the study, you will be asked to confirm your eligibility. This includes meeting specific criteria such as being between 18 and 75 years old, having a diagnosis of amyotrophic lateral sclerosis (ALS), and being able to walk and perform certain tests.

You will need to sign a written informed consent form to participate in the study.

2 initial assessment

An initial assessment will be conducted to establish a baseline for your walking capacity. This involves performing a 6-minute walking test (6MWT) and other muscle tests.

Your current medication regimen, including any use of riluzole, will be reviewed to ensure stability before starting the trial.

3 medication phase 1

You will begin taking the study medication, Ventoline 0.4 mg/ml oral solution, which contains salbutamol sulfate. This medication is taken orally.

For the first three months, you will take a dose of 2 mg three times a day (TID).

4 midpoint assessment

At the three-month mark, your walking capacity will be reassessed using the 6-minute walking test (6MWT) to measure any changes from the baseline.

5 medication phase 2

For the next three months, the dosage of the study medication will be increased to 4 mg, taken three times a day (TID).

6 final assessment

At the end of the six-month period, a final assessment will be conducted. This will include another 6-minute walking test (6MWT) to evaluate changes in your walking capacity since the start of the trial.

Who Can Join the Study?

Patients must have a diagnosis of Amyotrophic Lateral Sclerosis (ALS) according to specific medical guidelines called the revised El Escorial criteria.
Patients must be adults between the ages of 18 and 75.
Patients must be able to walk and perform a walking test called the 6-Minute Walk Test (6MWT) and muscle strength tests during the screening.
Patients must be able and willing to travel to the study site and are expected to attend visits for at least 6 months, according to the study doctor’s opinion.
Patients must sign a written agreement to participate, known as informed consent.
Patients must have been on a stable dose of a medication called riluzole for at least 4 weeks before starting the study, or they must not have taken it for 4 weeks before starting the study.
Patients must be part of the French social security system, except for a specific program called AME.
Women who can have children must use effective birth control.
Patients must have a lung function test result called Forced Vital Capacity (FVC) greater than 70% while sitting.

Who Cannot Join the Study?

Patients with any other serious medical condition that might interfere with the study.
Patients who are unable to walk at all.
Patients who have had a recent surgery or are planning to have surgery during the study period.
Patients who are currently participating in another clinical trial.
Patients who have a known allergy to salbutamol (a medication used to help with breathing).
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have a mental health condition that might affect their ability to participate in the study.
Patients who are unable to provide informed consent (agreement to participate after understanding the study).

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Association Institut De Myologie	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.04.2023

Trial locations

Investigated drugs:

Salbutamol Sulfate

Salbutamol is a medication commonly used to help people with breathing problems, like asthma, by relaxing the muscles in the airways and increasing airflow to the lungs. In this clinical trial, salbutamol is being tested to see if it can improve the walking ability of patients with ALS, a condition that affects nerve cells in the brain and spinal cord, leading to muscle weakness. The goal is to determine if salbutamol can help these patients walk better by potentially improving muscle function or strength.

Investigated diseases:

Amyotrophic lateral sclerosis

Amyotrophic Lateral Sclerosis (ALS) – Amyotrophic Lateral Sclerosis is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. It leads to the gradual degeneration and death of motor neurons, which are responsible for controlling voluntary muscles. As these neurons die, the brain loses the ability to initiate and control muscle movement. This results in muscle weakness and atrophy, often starting in the limbs and spreading to other parts of the body. Over time, individuals with ALS may experience difficulty in speaking, swallowing, and breathing. The progression of the disease varies among individuals, but it typically leads to increasing disability.

Trial ID:

2022-501624-14-00

Protocol code:

APHP190724

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effect of Salbutamol on Walking Ability in Patients with ALS

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