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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514082-19-00

Acronym

CORT113176-652

Enrollment

225

Registered

2024-10-14

Start date

2022-11-04

Completion date

Unknown

Last updated

2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Brief summary

Primary Efficacy Endpoint: Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score., Primary Safety Endpoints: Incidence of AEs, SAEs, treatment-related AEs, AEs by severity, and death due to AEs.

Detailed description

Change from Baseline to Week 24 in muscle strength (assessed using hand-held dynamometer)., Change from Baseline to Week 24 in: − Percent Slow Vital Capacity − EQ-5D-5L., Time to death., Time to respiratory support >22 hours per day for 7 days., Time to death or time to respiratory support >22 hours per day for 7 days., Combined Assessment of Function and Survival (CAFS)., Plasma samples for pharmacokinetic (PK) analysis will be obtained in a dedicated PK substudy in a subset (~20%) of patients at the Week 3 visit. The dazucorilant AUC and Cmax will be reported.

Interventions

DRUGPlacebo to Dazucorilant softgel capsule

DRUGCORT113176

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary Efficacy Endpoint: Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score., Primary Safety Endpoints: Incidence of AEs, SAEs, treatment-related AEs, AEs by severity, and death due to AEs.	—

Secondary

Measure	Time frame
Change from Baseline to Week 24 in muscle strength (assessed using hand-held dynamometer)., Change from Baseline to Week 24 in: − Percent Slow Vital Capacity − EQ-5D-5L., Time to death., Time to respiratory support >22 hours per day for 7 days., Time to death or time to respiratory support >22 hours per day for 7 days., Combined Assessment of Function and Survival (CAFS)., Plasma samples for pharmacokinetic (PK) analysis will be obtained in a dedicated PK substudy in a subset (~20%) of patients at the Week 3 visit. The dazucorilant AUC and Cmax will be reported.	—

Measure

Time frame

—

Countries

Belgium, France, Germany, Ireland, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026