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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Amyotrophic Lateral Sclerosis (ALS), a progressive disease that affects nerve cells in the brain and spinal cord, leading to muscle weakness and loss of muscle control. The study is testing a new treatment called dazucorilant, also known by its code name CORT113176. This treatment is being compared to a placebo to evaluate its safety and effectiveness in patients with ALS.

The purpose of the study is to assess how well dazucorilant works and how safe it is for people with ALS. Participants in the study will be randomly assigned to receive either dazucorilant 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 helps ensure that the results are unbiased. The study will take place over several months, with regular check-ups to monitor the participants' health and any changes in their condition.

Throughout the study, participants will be asked to take capsules of the study medication by mouth. The researchers will track changes in the participants' ability to perform daily activities and any side effects they may experience. The study aims to provide valuable information about the potential benefits and risks of using dazucorilant for treating ALS, which could lead to new treatment options for this challenging condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will attend an initial visit. During this visit, you will undergo various assessments to confirm your eligibility for the trial. This includes reviewing your medical history and conducting physical examinations.

    You will be asked to provide written informed consent, indicating your understanding of the study's purpose and any potential risks involved.

  2. Step 2

    Randomization

    After confirming eligibility, you will be randomly assigned to receive either the study medication, dazucorilant (CORT113176), or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.

    This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving to ensure unbiased results.

  3. Step 3

    Medication administration

    You will take the assigned medication orally in the form of a softgel capsule. The dosage and frequency will be determined by the study protocol, and you will be instructed on how to take the medication correctly.

    The duration of the medication administration will be specified in the study plan, and you will be required to adhere to this schedule throughout the trial.

  4. Step 4

    Regular follow-up visits

    You will attend regular follow-up visits as scheduled by the study team. These visits are crucial for monitoring your health and the effects of the medication.

    During these visits, various tests and assessments will be conducted, including evaluations of muscle strength and respiratory function, to track any changes from the baseline.

  5. Step 5

    End of treatment evaluation

    At the end of the treatment period, you will undergo a final evaluation. This will include a comprehensive assessment of your condition and any changes observed during the trial.

    The study team will discuss the results with you and provide any necessary follow-up care or recommendations.

Who can join the trial?

7 criteria

  • Male and female patients who are 18 years of age or older with Amyotrophic Lateral Sclerosis (ALS) as defined by specific criteria.
  • Patients with either sporadic or familial ALS who have a risk of ALS progression characterized by a specific score range.
  • Patients can continue using approved therapies for ALS. If taking medications like riluzole, edaravone, and/or sodium phenylbutyrate and taurursodiol, they must have been on a stable dose for a certain period before the study starts.
  • Medically able to participate in the study procedures and follow the visit schedule, as determined by the study doctor.
  • Able to understand the purpose and risks of the study and willing to follow the scheduled visits, treatment plans, tests, and other study procedures.
  • Provide written consent to participate in the study.
  • Male patients and female patients who can have children must agree to use a specific method of birth control from the start of the study until 28 days after the last dose of the study drug.

Who cannot join the trial?

4 criteria

  • Patients who do not have Amyotrophic Lateral Sclerosis (ALS) cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who belong to certain clinical trial groups that are not included in this study cannot participate.
  • Patients who are part of a vulnerable population that is not selected for this study cannot participate.
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Investigated drugs

Dazucorilant is a medication being studied for its potential to help people with Amyotrophic Lateral Sclerosis (ALS), a condition that affects the nerves and muscles. The goal of using dazucorilant in this trial is to see if it can improve the symptoms of ALS and to ensure it is safe for patients to use. This medication is being tested to understand how it might help slow down the progression of the disease and improve the quality of life for those affected by ALS.

What is already known about the treatment

Dazucorilant – Dazucorilant is administered orally and is currently being studied in clinical trials for its potential use in treating Amyotrophic Lateral Sclerosis (ALS). It is in the experimental phase, and researchers are evaluating its safety and effectiveness in patients with ALS. The medication works by modulating certain receptors in the body that may help reduce inflammation and protect nerve cells. Dazucorilant is classified as a glucocorticoid receptor antagonist, which means it blocks specific receptors that are involved in the body's stress response.

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 typically leads to increasing physical disability.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514082-19-00Protocol codeCORT113176-652Estimated enrolment279 patientsSponsorCorcept Therapeutics Inc.

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