> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/dazucorilant-in-patients-with-amyotrophic-lateral-sclerosis-2d69a249-d7b3-4733-8ef9-9750e55b69b5 > Record changed: 2026-10-13 # Dazucorilant in Patients With Amyotrophic Lateral Sclerosis NCT05407324 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) Participants 279 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) Lead sponsor Corcept Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) Start date 2022-11-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) Number of sites 35 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) ## Title and summary **Summary** The purpose of this 2-part study is to assess the safety and efficacy of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (ALS). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) **Acronym** DAZALS Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) **Short title** Dazucorilant in Patients With Amyotrophic Lateral Sclerosis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) **Official title** A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of CORT113176 (Dazucorilant) in Patients With Amyotrophic Lateral Sclerosis (DAZALS) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) ## Dates **Completion date** 2027-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) **First posted** 2022-06-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) **Registry last updated** 2026-06-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) **Primary completion date** 2026-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) **Start date** 2022-11-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) ## Size and sites **Participants** 279 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) **Planned participants** 279 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) **Protocol amendments** 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) **Randomisation ratio** 1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) **Number of sites** 35 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) **Lead sponsor** Corcept Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) ## Identifiers **Registry ID** NCT05407324 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) **ClinicalTrials.gov ID** NCT05407324 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) ## Outcomes ### Primary outcomes 1. Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score. Timeframe: Baseline to Week 24 This outcome measure is assessed in study Part 1. 2. Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, AEs by severity, and deaths due to AEs Timeframe: Baseline to Week 24 This outcome measure is assessed in study Part 1. 3. Incidence of treatment-emergent AEs and SAEs Timeframe: Baseline up to Week 12 This outcome measure is assessed in study Part 2. 4. Incidence of treatment-emergent AEs leading to dose interruptions, dose reductions, and/or discontinuations of study drug Timeframe: Baseline up to Week 12 This outcome measure is assessed in study Part 2. ### Secondary outcomes 1. Change from Baseline to Week 24 in muscle strength (assessed using hand-held dynamometer) Timeframe: Baseline to Week 24 This outcome measure is assessed in study Part 1. 2. Change from Baseline to Week 24 in Percent Slow Vital Capacity Timeframe: Baseline to Week 24 This outcome measure is assessed in study Part 1. 3. Change from Baseline to Week 24 in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Timeframe: Baseline to Week 24 This outcome measure is assessed in study Part 1. 4. Time to Death Timeframe: From randomization date to the date of death from any cause up to 156 weeks This outcome measure is assessed in study Part 1. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Male and female patients ≥18 years of age with sporadic or familial ALS. In Part 1, patients must have a risk of ALS progression characterized by a European Network for the Cure of ALS (ENCALS) risk profile score ≥ -6 and ≤ -3\. In Part 2 patients must have a risk of ALS progression characterized by an Treatment Research Initiative to Cure ALS (TRICALS) risk profile score ≥ -7 and ≤ -3. - If taking riluzole, edaravone, and/or sodium phenylbutyrate and taurursodiol, must be on a stable dose prior to Screening. Sodium phenylbutyrate and taurursodiol are not permitted for patients enrolled in Part 2 of the study. - Part 2 only: Patients with a pathogenic mutation in superoxide dismutase 1 gene (SOD1) must not be receiving treatment with tofersen or eligible for treatment with tofersen if available. Patients who have received prior treatment with tofersen and discontinued due to safety and/or efficacy reasons prior to Screening are eligible. - Part 2 only: Use of ultra high-dose methylcobalamin for the treatment of ALS is permitted provided the patient has been on a stable dose for ≥11 weeks prior to the Day 1 visit. ### Exclusion criteria - History of a clinically significant non-ALS neurologic disorder - Inability to swallow capsules. - Blood platelet count <150,000/mm^3. - Renal impairment indicated by Estimated Glomerular Filtration Rate (eGFR) ≤30 mL/min/1.73 m^2\. Part 2 only: Patients with a recent history of acute kidney injury should have returned to their baseline renal function (i.e, eGFR prior to acute kidney injury) prior to enrollment. - Human immunodeficiency virus (HIV) or current chronic/active infection with hepatitis C virus or hepatitis B virus. Part 2 only: Known history of HIV or chronic/active infection with hepatitis C or hepatitis B virus; testing does not need to be performed if infection status is unknown. - 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. - Cancer that is currently being treated (except adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin, stage I endometrial cancer or carcinoma in situ of the cervix or breast) or a history of cancer with an expected survival < 2 years. - Current or anticipated need of a diaphragm pacing system (DPS). - Previous exposure or treatment with glucocorticoid receptor modulators or antagonists. - Taking, or have taken, any systemic, inhaled, or potent dermatologic topical corticosteroids (Class I to III) within a period equivalent to 5 half-lives of the corticosteroid used prior to first dose of study drug. Patients who have stopped glucocorticoid use should have an alternative option if their condition deteriorates during the study. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) ## Sites - 062Phoenix, United StatesRecruiting - 278San Francisco, United StatesRecruiting - 287Neptune City, United StatesRecruiting - 353New York, United StatesRecruiting - 108Leuven, BelgiumActive, not recruiting - 425Hamilton, CanadaActive, not recruiting - 273Montreal, CanadaActive, not recruiting - 422Bron, FranceActive, not recruiting - 258Lille, FranceActive, not recruiting - 257Limoges, FranceActive, not recruiting - 261Marseille, FranceActive, not recruiting - 423Montpellier, FranceActive, not recruiting - 259Nice, FranceActive, not recruiting - 262Paris, FranceActive, not recruiting - 256Tours, FranceActive, not recruiting - 255Berlin, GermanyActive, not recruiting - 270Bonn, GermanyRecruiting - 268Dresden, GermanyActive, not recruiting - 260Hanover, GermanyActive, not recruiting - 265Jena, GermanyActive, not recruiting - 386München, GermanyActive, not recruiting - 267Rostock, GermanyActive, not recruiting - 269Ulm, GermanyActive, not recruiting - 253Dublin, IrelandActive, not recruiting - 264Utrecht, NetherlandsRecruiting And 10 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) ## References ### Other registry identifiers - 2021-005611-31 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05407324) ## Related records ### Drugs (1) - [Dazucorilant](https://trialight.com/data/asset/dazucorilant-ca3d0014-18ff-41d5-bc23-88f1eb00acd8.md) ### Lead sponsors (1) - [Corcept Therapeutics](https://trialight.com/data/company/corcept-therapeutics-854925e2-55aa-4b8b-92d8-af8bdcc20ee9.md) ### Conditions (1) - [Amyotrophic lateral sclerosis](https://trialight.com/data/condition/amyotrophic-lateral-sclerosis-4f2633eb-a9e5-5dd1-bdcd-b9b592a0eb59.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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