Study Purpose:The purpose of this study is to assess the safety and efficacy of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (ALS).
Not yet recruiting
Amyotrophic Lateral Sclerosis
Type of Intervention:
Dazucorilant 300 mg, Dazucorilant 150 mg, Placebo
Study Chair(s)/Principal Investigator(s):
Grace Mann, PhD, Corcept Therapeutics
Coordinating Center Contact Information
Full Study Summary:
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.
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
- 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.
- 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.