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Study on the Effects of Rituximab 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 treatment for Amyotrophic Lateral Sclerosis (ALS), a progressive disease that affects nerve cells in the brain and spinal cord, leading to muscle weakness and loss of motor function. The study will evaluate the use of Rituximab, a medication that targets specific cells in the immune system, to see if it can slow down the progression of symptoms in patients with ALS. The trial will compare the effects of Rituximab when added to the standard therapy, which includes a medication called riluzole, against the standard therapy alone.

Participants in the study will receive either Rituximab or a placebo, in addition to their regular treatment. The study will last for a period of 79 weeks, during which participants will undergo regular assessments to monitor their health and the progression of their symptoms. These assessments will include tests to measure lung function, changes in body weight, and overall survival without the need for a tracheostomy, which is a procedure to help with breathing. The study will also look at the safety of Rituximab by checking laboratory parameters and conducting neuropsychological tests to assess cognitive function.

The goal of this study is to determine if Rituximab can provide additional benefits to patients with ALS by slowing down the progression of the disease and improving their quality of life. The results will help to understand the potential of Rituximab as a treatment option for ALS and its impact on patients’ health and well-being over time.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria, such as the duration of your condition and your ability to attend study visits.

You will be asked to provide written consent to participate in the study. Your current medication, including riluzole, will be reviewed to ensure it has been stable for at least 30 days prior to this visit.

2 screening tests

Screening tests will be conducted to assess your health status. These tests include a pulmonary function test to measure your slow vital capacity, which should be equal to or more than 75% of the predicted normal value.

Blood tests will be performed to check for any underlying infections, including Hepatitis B. If necessary, vaccinations will be recommended.

3 first infusion

You will receive your first dose of rituximab through an intravenous infusion. This is a process where the medication is delivered directly into your bloodstream through a vein.

You may also receive other medications such as methylprednisolone and paracetamol to help manage any potential side effects.

4 follow-up visits

Regular follow-up visits will be scheduled to monitor your health and the progression of your symptoms. These visits will include assessments using the ALS Functional Rating Scale and other tests to evaluate your lung function and overall health.

Additional doses of rituximab may be administered during these visits, as per the study protocol.

5 final assessment

At the end of the study period, a final assessment will be conducted. This will include a comprehensive evaluation of your health, including any changes in your symptoms and overall well-being.

The results of this assessment will help determine the effectiveness and safety of rituximab as a treatment for ALS.

Who Can Join the Study?

  • The patient must have been diagnosed with Sporadic Amyotrophic Lateral Sclerosis (ALS) for 24 months or less since symptoms started. The symptoms should not have progressed to needing permanent assisted breathing support.
  • The patient must be at least 18 years old.
  • The patient must provide written consent to participate in the study.
  • The patient must be able to attend study visits.
  • The patient must be taking the medication riluzole at a stable dose of 50 mg twice a day for at least 30 days before the screening visit and, if possible, continue throughout the study.
  • The patient must have a slow vital capacity (VC) of 75% or more of the predicted normal value for their gender, height, and age at the screening visit. (Slow vital capacity is a measure of lung function.)
  • The patient should have received the recommended standard vaccinations according to STIKO guidelines, including the COVID-19 vaccine, but not Hepatitis B. Hepatitis B will be checked at screening to rule out an infection. If vaccinations are missing, it is recommended to get them during the trial.
  • The patient must have the capacity to give informed consent, meaning they understand the study and agree to participate.

Who Cannot Join the Study?

  • Patients who are not diagnosed with Sporadic Amyotrophic Lateral Sclerosis (ALS) cannot participate. ALS is a disease that affects nerve cells in the brain and spinal cord, leading to muscle weakness.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study but is not specified here.
  • Patients who are not part of the specified clinical trial group cannot participate. This group is defined by the study but is not specified here.
  • Patients who are not male or female cannot participate, as the study includes both genders.
  • Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes individuals who may have difficulty giving informed consent or are at higher risk of harm.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Charite Research Organisation GmbH Berlin Germany
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V. Bonn Germany

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

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
01.09.2023

Trial locations

Investigated drugs:

Rituximab is a medication used in this clinical trial to help treat patients with amyotrophic lateral sclerosis (ALS). It works by targeting and reducing the number of B-cells in the body. B-cells are a type of white blood cell that can play a role in the immune system’s response. In this study, Rituximab is being tested to see if it can slow down the progression of ALS symptoms when used alongside standard treatments. The goal is to see if reducing B-cells can have a positive effect on the disease’s progression.

Investigated diseases:

Sporadic Amyotrophic Lateral Sclerosis – Sporadic 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 the disease progresses, individuals experience increasing muscle weakness and atrophy, affecting their ability to move, speak, swallow, and eventually breathe. The progression of muscle weakness is typically asymmetric and can start in any part of the body. Over time, the loss of motor neurons leads to complete paralysis. The rate of progression can vary significantly among individuals.

Trial ID:
2022-502743-35-00
Protocol code:
RituxALS01
Trial Phase:
Therapeutic exploratory (Phase II)

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