Dazucorilant in Patients With Amyotrophic Lateral Sclerosis (DAZALS)

• Status: Not yet recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Corcept Therapeutics

Criteria

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.