Study on the Effectiveness and Safety of Masitinib with Riluzole for Patients with Amyotrophic Lateral Sclerosis (ALS)

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What is this study about?

This clinical trial is focused on studying the effects of a medication called masitinib in combination with another drug, Riluzole, for treating patients with Amyotrophic Lateral Sclerosis (ALS). ALS is a progressive disease that affects nerve cells in the brain and spinal cord, leading to muscle weakness and loss of muscle control. The purpose of the study is to evaluate how effective and safe masitinib is when used alongside Riluzole in people diagnosed with ALS.

Participants in the study will be randomly assigned to receive either masitinib with Riluzole or a placebo with Riluzole. A placebo is a substance with no active medication, used to compare the effects of the actual drug. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, ensuring unbiased results. The study will last for a period of 48 weeks, during which participants will take the medication orally in the form of coated tablets.

Throughout the study, participants will be monitored for changes in their condition, focusing on their ability to perform daily activities and any side effects they may experience. The main goal is to see if there is an improvement in the symptoms of ALS when masitinib is added to the standard treatment with Riluzole. This research aims to provide valuable insights into potential new treatment options for those living with ALS.

1 initial visit

The patient attends an initial visit to confirm eligibility for the study. This includes a review of the diagnosis of amyotrophic lateral sclerosis (ALS) and ensuring the patient meets specific criteria, such as age and previous treatment with Riluzole.

2 randomization

The patient is randomly assigned to one of the study groups. This could be a group receiving masitinib or a placebo, both in combination with Riluzole.

3 treatment phase

The patient begins the treatment phase, which involves taking the assigned medication orally. The dosage of masitinib is either 100 mg or 200 mg, depending on the group assignment. The patient continues to take Riluzole at a stable dose of 100 mg per day.

The treatment phase lasts for 48 weeks, during which the patient will have regular check-ups to monitor health and any changes in symptoms.

4 follow-up visits

Throughout the study, the patient attends scheduled follow-up visits. These visits are used to assess the patient’s condition, adjust treatment if necessary, and ensure safety. The patient’s progress is measured using various assessments, including changes in the ALS Functional Rating Scale-Revised (ALSFRS-R) score.

5 end of study

At the end of the 48-week treatment period, the patient undergoes a final evaluation. This includes a comprehensive assessment of the treatment’s impact on ALS symptoms and overall health.

Who Can Join the Study?

The patient must be diagnosed with Amyotrophic Lateral Sclerosis (ALS), which is a condition affecting the nerve cells in the brain and spinal cord.
The patient can have either familial (inherited) or sporadic (not inherited) ALS.
The patient must be between 18 and 80 years old.
The patient should have been taking a stable dose of Riluzole (100 mg per day) for at least 12 weeks before the start of the study. Riluzole is a medication used to treat ALS.
The patient must have been diagnosed with ALS no more than 24 months before joining the study.
The patient should have a specific rate of progression in their ALS symptoms, measured by a tool called ALSFRS-R. This tool helps track the progression of ALS by scoring different abilities.
The patient must have a certain score on the ALSFRS-R scale at the start of the study, indicating their level of function.
The patient must agree to use effective birth control methods if they or their partner can have children, during the study and for a period after the study ends.
The patient must be able to understand and agree to sign a consent form, or have a representative do so if they are unable to sign due to their condition.
The patient must be willing and able to follow the study’s rules and attend scheduled visits.
The patient must understand and agree to follow safety procedures if they experience certain side effects, like severe neutropenia (a low level of white blood cells) or severe skin reactions.

Who Cannot Join the Study?

Patients who do not have a diagnosis of Amyotrophic Lateral Sclerosis (ALS) cannot participate. ALS is a disease that affects nerve cells in the brain and spinal cord.
Patients who are not taking Riluzole as part of their treatment cannot participate. Riluzole is a medication used to treat ALS.
Patients who are not within the specified age range for the study cannot participate. The study is open to adults.
Patients who are unable to follow the study procedures or attend study visits cannot participate.
Patients with other medical conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients with a history of allergic reactions to the study medication cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
CHU Gui de Chauliac	Montpellier	France
Bispebjerg Hospital	Copenhagen	Denmark

Other Sites

Site Name	City	Country
General University Hospital Of Patras	Patras	Greece
CHU Gabriel-Montpied	Clermont Ferrand	France
Athens Naval Hospital	Athens	Greece
Norrlands University Hospital	Umea	Sweden
Hospices Civils De Lyon	Lyon	France
CHU de Lille, Hôpital Roger Salengro	Lille	France
Olso University Hospital	Oslo	Norway
Caf dk Nupbi Haledtk Plxkxyh 2	Nice	France
Uxhqncgtzw Gnuilmv Hysdaqzd or Lccftv	Larissa	Greece
Ecianntii Heykmjyu	Athens	Greece
Aqojveblqh Pugmjvkl Hgrhezhs Dg Mwbzzgnni	Marseille	France
Cyzhtl Hysyvglnhgk Ey Ukhmlsoythkce Dz Lmxepxk	Limoges	France
Ayhhrb Usjueipcmn Hnyspppc	Aarhus	Denmark
Csnobm Hqpsangsira Rkuyruzm Umqollqdilssc Dg Tpfbp	Tours	France
Cbjqsc Hwvtogzvijj Rpybkkss Djghkldsoxuedm	Angers	France
Cinv Do Nnlev	Vandoeuvre Les Nancy	France

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	01.10.2019
France	Not yet recruiting	01.10.2019
Greece	Not yet recruiting	01.10.2019
Norway	Not yet recruiting	01.10.2019
Sweden	Not recruiting	01.10.2019

Trial locations

Investigated drugs:

Masitinib

Masitinib is a medication being studied for its potential to help treat Amyotrophic Lateral Sclerosis (ALS). It is being tested to see if it can improve the symptoms of ALS when used alongside another medication called Riluzole. Researchers are looking at how effective and safe it is for patients with this condition.

Riluzole is a medication that is already used to treat ALS. It works by slowing down the progression of the disease. In this study, Riluzole is used as a standard treatment to see if adding Masitinib can provide additional benefits to patients with ALS.

Amyotrophic Lateral Sclerosis – This is a progressive neurological 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 the disease progresses, individuals experience increasing muscle weakness and atrophy, affecting their ability to move, speak, swallow, and eventually breathe. The progression of symptoms varies among individuals, but it typically starts with muscle twitching and weakness in a limb or slurred speech. Over time, the disease spreads to other parts of the body, leading to more severe physical impairments. Despite the loss of muscle function, the disease does not usually affect the senses or cognitive abilities.

Trial ID:

2024-516671-33-00

Protocol code:

AB19001

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Masitinib with Riluzole for Patients with Amyotrophic Lateral Sclerosis (ALS)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?