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

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.