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Study on the Effects of EH-301, N-Acetylcysteine, and Riluzole in 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 a combination therapy that includes N-Acetylcysteine (NAC), a substance known for its antioxidant properties, and EH-301, alongside the medication Riluzole, which is commonly used to treat ALS. The purpose of the study is to assess the safety and effectiveness of this combined treatment in slowing down the progression of ALS.

Participants in the study will be randomly assigned to receive either the combination therapy or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This approach helps ensure that the results are unbiased. The treatment will be administered orally, and participants will be monitored over a period of time to observe any changes in their condition, particularly focusing on their ability to perform daily activities and their overall quality of life.

The study aims to gather valuable information on how the combination of NAC, EH-301, and Riluzole affects the progression of ALS. By using the ALS Functional Rating Scale-Revised (ALSFRS-R), researchers will evaluate changes in participants’ physical abilities. Additionally, the study will look at other factors such as muscle strength, respiratory function, and survival rates. The findings from this study could contribute to developing more effective treatments for individuals living with ALS.

1 initial visit

Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria, such as age, diagnosis of amyotrophic lateral sclerosis (ALS), and current health status.

A detailed explanation of the study procedures, potential risks, and benefits is provided. Written informed consent is obtained before any study-related activities begin.

2 baseline assessment

A comprehensive assessment is conducted to establish baseline health status. This includes measuring muscle strength, respiratory function, and quality of life using specific scales.

The ALS Functional Rating Scale-Revised (ALSFRS-R) is used to evaluate the current level of function.

3 medication regimen

Participants are required to continue taking riluzole at a dose of 50 mg twice daily. This medication should have been taken for at least 30 days prior to the start of the study and will continue throughout the trial.

In addition to riluzole, participants will receive either a combination of N-acetylcysteine (NAC) and EH-301 or a placebo. The specific dosage and frequency of these additional treatments are determined by the study protocol.

4 follow-up visits

Regular follow-up visits are scheduled to monitor health status and any changes in symptoms. These visits include assessments similar to the baseline assessment, focusing on muscle strength, respiratory function, and quality of life.

Adjustments to the treatment regimen may be made based on the participant’s response and any side effects experienced.

5 final assessment

At the end of the study period, a final assessment is conducted. This includes a comprehensive evaluation of the participant’s health status and any changes in the ALSFRS-R score.

The results of the study are analyzed to determine the effectiveness and safety of the treatment regimen.

Who Can Join the Study?

  • Patients must be diagnosed with Amyotrophic Lateral Sclerosis (ALS) according to specific medical guidelines known as the Gold Coast criteria.
  • The disease must have been present for 18 months or less.
  • Participants must be between 18 and 75 years old.
  • The ALS Functional Rating Scale-Revised (ALSFRS-R) score, which measures the ability to perform daily activities, must be 30 or higher across all 12 categories.
  • The Forced Vital Capacity (FVC), a test that measures lung function, must be 70% or higher.
  • Participants must be taking a medication called Riluzole (50 mg twice daily) for at least 30 days before starting the study and continue this dose until the study ends.
  • Participants must be willing and able to follow the study’s requirements.
  • Participants must sign a written consent form before any study-related procedures begin.
  • Women of childbearing age must agree to use specific contraceptive methods starting 30 days before taking the study medication and continue throughout the study. Acceptable methods include non-hormonal intrauterine device (IUD), barrier methods like condoms, surgical sterilization, having a partner who has had a vasectomy, or abstaining from sexual intercourse.

Who Cannot Join the Study?

  • Patients who are not able to walk or move around on their own.
  • Patients who have not been diagnosed with Amyotrophic Lateral Sclerosis (ALS) using the ALS Functional Rating Scale-Revised (ALSFRS-R) score.
  • Patients who are under the age of 18 or over the age of 75.
  • Patients who are part of a vulnerable population, such as those who cannot give consent for themselves.

Where you can join this trial?

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Site Name City Country Status
Hmuwfcpo Uhnkiygvvcnpe Dyyfyomn Donostia / San Sebastian Spain

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

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
01.03.2025

Trial locations

Investigated drugs:

EH-301 is a medication being studied for its potential to help people with Amyotrophic Lateral Sclerosis (ALS), a condition that affects the nerves and muscles. In this trial, EH-301 is being tested to see if it can slow down the progression of ALS when used together with other treatments. The goal is to find out if EH-301 can help improve or maintain the ability to perform daily activities, which is often measured by a specific scale used for ALS patients.

N-Acetylcysteine, often called NAC, is a supplement that is being tested in this trial for its potential benefits in treating ALS. NAC is known for its antioxidant properties, which means it might help protect cells from damage. In this study, researchers are looking to see if NAC can help slow down the progression of ALS when used in combination with other treatments. The hope is that NAC can help patients maintain their ability to perform everyday tasks for a longer period.

Riluzole is a medication that is already used to treat ALS. It works by affecting the nerve cells in the brain and spinal cord, which can help slow down the progression of the disease. In this trial, Riluzole is being used as part of a combination therapy to see if it can be even more effective when used together with other treatments like EH-301 and NAC. The aim is to see if this combination can help patients maintain their physical abilities and improve their quality of life.

Investigated diseases:

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 speaking, swallowing, and breathing. The progression of the disease varies among individuals, but it typically leads to increasing physical disability.

Trial ID:
2024-519857-13-00
Protocol code:
NADALS-001-ALS -2021
Trial Phase:
Human Pharmacology (Phase I) – Other

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