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Study on the Effectiveness and Safety of Masitinib and 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 standard care for patients 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 loss of motor function. The study aims to evaluate how effective and safe masitinib is when added to the usual treatment for ALS.

Participants in the trial will receive either masitinib or a placebo, both in combination with their standard ALS treatment. Masitinib is a type of medication known as a tyrosine kinase inhibitor, which works by blocking certain proteins that can contribute to disease progression. The trial will last for a period of 48 weeks, during which participants will take the medication orally in the form of coated tablets. The study will monitor changes in the participants’ condition and any side effects they may experience.

In addition to masitinib, some participants will continue taking another medication called Riluzole, which is commonly used in ALS treatment. The trial will compare the outcomes of those taking masitinib with those taking a placebo to determine the added benefits of masitinib. The goal is to provide more information on how masitinib can be used to improve the quality of life for people living with ALS.

1 initial visit

Upon joining the study, the patient will attend an initial visit. During this visit, the patient will receive detailed information about the trial procedures and will be asked to provide informed consent. This consent confirms the patient’s understanding and willingness to participate in the trial.

The patient will undergo a series of assessments to confirm eligibility, including a review of medical history and current health status. The patient must have been on a stable dose of riluzole (100 mg/day) for at least 30 days prior to this visit.

2 randomization

After eligibility is confirmed, the patient will be randomly assigned to one of two groups. One group will receive masitinib in combination with standard care, while the other group will receive a placebo in combination with standard care.

The trial is double-blind, meaning neither the patient nor the healthcare providers will know which group the patient is in.

3 treatment phase

The patient will begin the treatment phase, which lasts for 48 weeks. If assigned to the masitinib group, the patient will take masitinib orally at a dose of 4.5 mg/kg/day. If assigned to the placebo group, the patient will take a placebo tablet orally.

Throughout the treatment phase, the patient will continue taking riluzole as part of the standard care.

4 regular assessments

The patient will attend regular visits to monitor health and response to treatment. These visits will include physical examinations, blood tests, and assessments of muscle strength and lung function.

The patient’s progress will be evaluated using the ALS Functional Rating Scale-Revised (ALSFRS-R), which measures the patient’s ability to perform daily activities.

5 end of treatment

At the end of the 48-week treatment phase, the patient will undergo a final assessment to evaluate the overall response to the treatment.

The patient will be asked to provide feedback on their experience during the trial.

6 follow-up

After completing the treatment phase, the patient will enter a follow-up period. During this time, the patient’s health will continue to be monitored to assess any long-term effects of the treatment.

The follow-up period will include additional visits and assessments as needed.

Who Can Join the Study?

  • The patient must be diagnosed with Amyotrophic Lateral Sclerosis (ALS), which is a progressive nervous system disease that affects nerve cells in the brain and spinal cord.
  • The patient must be between 18 and 80 years old.
  • The patient must have either familial (inherited) or sporadic (not inherited) ALS.
  • The patient must have had the first symptoms of ALS no more than 36 months ago.
  • The patient must be taking a stable dose of Riluzole (100 mg/day) for at least 30 days before the screening visit. Riluzole is a medication used to treat ALS.
  • The patient may or may not be taking Edaravone. If taking Edaravone, it must be in oral suspension form and at a stable dose for at least 30 days before the screening visit. Edaravone is another medication used to treat ALS.
  • The patient must have an ALSFRS-R progression rate between 0.3 and 1.1 points per month. ALSFRS-R is a scale used to measure the progression of ALS.
  • The patient must have a certain ALSFRS-R total score at screening and baseline, with specific minimum scores on certain items of the scale.
  • Female patients of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the trial and for 8 months after the last treatment. Male patients with partners of childbearing potential must agree to use effective contraception during the trial and for 5 months after the last treatment.
  • The patient must not be a candidate for QALSODY® Tofersen treatment, which is another treatment for ALS.
  • The patient must be able to understand and willing to sign a written informed consent form. If unable to sign due to the disease, a legally authorized representative can sign on their behalf.
  • The patient must be able and willing to follow the trial protocol and attend scheduled visits.
  • The patient must be able to understand and willing to follow safety procedures in case of severe neutropenia (a low level of white blood cells) or severe cutaneous toxicity (skin reactions).

Who Cannot Join the Study?

  • Patients who are not diagnosed with Amyotrophic Lateral Sclerosis (ALS) cannot participate. ALS is a disease that affects nerve cells in the brain and spinal cord.
  • Patients who are not within the specified age range for the study cannot participate. The age range includes adults and older adults.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who have any other medical condition that might interfere with the study or pose a risk to their health cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are participating in another clinical trial cannot participate.
  • Patients who have a history of allergic reactions to the study medication or similar drugs 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
Universitaetsmedizin Goettingen Goettingen Germany
Centre Hospitalier Universitaire De Lille Lille France
Universitaet Leipzig Leipzig Germany
Bellvitge University Hospital L'hospitalet De Llobregat Spain
University Hospital Jena KöR Jena Germany

Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Erumyoazo Hbevwcyk Athens Greece
Czy do Nwsrc Hmmuemi Phdorro 2 Nice France
Nercjkwod utrsehddglamqypycpo Umea Sweden
Ctkniq Hlutbqnfkkv Eo Uaiijnynjdiwu Dh Lvyhvtp Limoges France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
02.09.2024
Germany Germany
Not yet recruiting
02.09.2024
Greece Greece
Not yet recruiting
02.09.2024
Latvia Latvia
Not yet recruiting
02.09.2024
Slovenia Slovenia
Not yet recruiting
02.09.2024
Spain Spain
Not yet recruiting
02.09.2024
Sweden Sweden
Not yet recruiting
02.09.2024

Trial locations

Investigated drugs:

Masitinib is a medication being studied for its potential to help people with Amyotrophic Lateral Sclerosis (ALS), a condition that affects the nerve cells in the brain and spinal cord. In this trial, masitinib is used alongside the usual treatments for ALS to see if it can improve the symptoms or slow down the progression of the disease. The goal is to determine if adding masitinib to the standard care can make a difference in the health and quality of life for patients with ALS.

Investigated diseases:

Amyotrophic Lateral Sclerosis – Amyotrophic Lateral Sclerosis (ALS) 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 speaking, swallowing, and breathing. The progression of the disease varies among individuals, but it generally leads to increasing disability.

Trial ID:
2024-511244-12-01
Protocol code:
AB23005
Trial Phase:
Therapeutic confirmatory (Phase III)

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