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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Medizinische Hochschule Hannover	Hanover	Germany
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Linden Sp. z o.o. sp.k.	Cracow	Poland
City Clinic Research Sp. z o.o.	Warsaw	Poland
University Hospital Jena KöR	Jena	Germany
Rostock University Medical Center	Rostock	Germany
Centre Hospitalier Universitaire De Lille	Lille	France
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Hospital Del Mar	Barcelona	Spain
Centrum Medyczne Neuromed Sp. z o.o.	Bydgoszcz	Poland
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Centre Hospitalier Universitaire De Nice	Nice	France
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Neuroprotect Sp. z o.o.	Warsaw	Poland
Beaumont Hospital	Dublin	Ireland
Ciffna Hgawmlbzwek Eo Usdfckfgldwkm Dp Lclhqkt	Limoges	France
Acepunlyja Pvfhhtbe Hhjctzuo Dr Mdebgcyht	Marseille	France
Ckuxxy Hoxlphhxlrz Rowyoaiy Uicifilnytqqm Dy Txixz	Tours	France
Fnrrqghus Pccz Lv Izkpgffkmsbtn Bvwdzpydp Diy Hirwqygd Uetlwecxryjbb Lp Pyb	Madrid	Spain
Hdrtqqzt Vosj dctxpaaf	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	14.11.2022
France	Not recruiting	14.11.2022
Germany	Not recruiting	14.11.2022
Ireland	Not recruiting	14.11.2022
Poland	Not recruiting	14.11.2022
Spain	Not recruiting	14.11.2022
The Netherlands	Recruiting	14.11.2022

Trial locations

Investigated drugs:

Dazucorilant

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.

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 ID:

2024-514082-19-00

Protocol code:

CORT113176-652

NCT ID:

NCT05407324

Trial Phase:

Therapeutic exploratory (Phase II)

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

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