NCT05407324Phase 2Active not recruiting

Dazucorilant in Patients With Amyotrophic Lateral Sclerosis

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2026-10Estimated

Enrollment · participants279Estimated

Source updated2026-09-24Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-09-24 · 1 field changed

Recruitment status

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Recruiting

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Active not recruiting

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Posted 2026-06-16 · 1 field changed

Primary completion date

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2026-09

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2026-10

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Posted 2026-03-04 · 1 field changed

Recruitment status

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Active not recruiting

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Recruiting

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Posted 2025-12-22 · 5 fields changed

Primary outcomes · main study measures

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measure: Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score.; measure: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, AEs by severity, and deaths due to AEs; measure: Incidence of treatment-emergent AEs and SAEs; measure: Incidence of treatment-emergent AEs leading to dose interruptions, dose reductions, and/or discontinuations of study drug

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Participant count type

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Actual

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Estimated

Enrollment · participant count

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count: 249; type: ACTUAL

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count: 279; type: ESTIMATED

Completion date type

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Actual

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Estimated

Primary completion date

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2024-10-22

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2026-09

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Study details

Conditions studied

Amyotrophic Lateral Sclerosis

Treatments or interventions studied

Dazucorilant 300 mgDrugAlso known as CORT113176
Dazucorilant 150 mgDrugAlso known as CORT113176
DazucorilantDrugAlso known as CORT113176

Primary outcomes · main study measures

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measure: Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score.; description: This outcome measure is assessed in study Part 1.; timeFrame: Baseline to Week 24; measure: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, AEs by severity, and deaths due to AEs; description: This outcome measure is assessed in study Part 1.; timeFrame: Baseline to Week 24; measure: Incidence of treatment-emergent AEs and SAEs; description: This outcome measure is assessed in study Part 2.; timeFrame: Baseline up to Week 12; measure: Incidence of treatment-emergent AEs leading to dose interruptions, dose reductions, and/or discontinuations of study drug; description: This outcome measure is assessed in study Part 2.; timeFrame: Baseline up to Week 12

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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