A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of CORT113176 (Dazucorilant) in Patients With Amyotrophic Lateral Sclerosis (DAZALS)

Study Purpose:

The purpose of this study is to assess the safety and efficacy of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (ALS).

Study Status:

Not yet recruiting


Amyotrophic Lateral Sclerosis

Study Type:


Type of Intervention:

Drug, N/A

Intervention Name:

Dazucorilant 300 mg, Dazucorilant 150 mg, Placebo




Phase 2

Study Chair(s)/Principal Investigator(s):

Grace Mann, PhD, Corcept Therapeutics

Clinicaltrials.gov ID:


Neals Affiliated?


Coordinating Center Contact Information

Clinical Trial Lead / email hidden; JavaScript is required / (650) 327-3270

Full Study Summary:

Eligible ALS patients will be randomized to one of three treatment arms (1:1:1) across the United States and Europe for a 24-week double-blind treatment period.

Patients who complete participation (i.e., complete all visits) in the double-blind treatment period will be eligible for participation in a 24-week open-label extension (OLE) study. A daily dose of 300 mg dazucorilant will be used in the 24-week OLE period.

Patients that complete the double-blind treatment period and who do not enter the OLE will enter the 24-week follow-up period.

Study Sponsor:

Corcept Therapeutics

Estimated Enrollment:


Estimated Study Start Date:

09 / 01 / 2022

Estimated Study Completion Date:

11 / 01 / 2024

Posting Last Modified Date:

06 / 07 / 2022

Date Study Added to neals.org:

06 / 07 / 2022

Minimum Age:

18 Years

Maximum Age:


Inclusion Criteria:

- Male and female patients ≥18 years of age with Sporadic or familial ALS

- If taking riluzole and/or edaravone, must be on a stable dose prior to Screening.

Exclusion Criteria:

- History of a clinically significant non-ALS neurologic disorder

- Inability to swallow capsules.

- Human immunodeficiency virus (HIV) or current chronic/active infection with hepatitis C virus or hepatitis B virus

- Women who are pregnant, planning to become pregnant, or are breastfeeding.

- Use of non-invasive ventilation (NIV) or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation.

- Current or anticipated need of a diaphragm pacing system (DPS).

- Currently using glucocorticoids or have a history of regular systemic glucocorticoid use within the last 12 months.

- Previous exposure or treatment with glucocorticoid receptor modulators or antagonists.