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
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug, N/A
Intervention Name:
Dazucorilant 300 mg, Dazucorilant 150 mg, Placebo
Placebo:
Yes
Phase:
Phase 2
Study Chair(s)/Principal Investigator(s):
Grace Mann, PhD, Corcept Therapeutics
Clinicaltrials.gov ID:
Neals Affiliated?
No
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.
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:
198
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:
N/A
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.