Dazucorilant in Patients With Amyotrophic Lateral Sclerosis (DAZALS)
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|ClinicalTrials.gov Identifier: NCT05407324|
Recruitment Status : Recruiting
First Posted : June 7, 2022
Last Update Posted : March 10, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Drug: Dazucorilant 300 mg Drug: Dazucorilant 150 mg Other: Placebo||Phase 2|
Eligible ALS patients will be randomized to one of three treatment arms (1:1:1) across the United States and Europe for a 24-week double-blind treatment period.
Patients who complete participation (i.e., complete all visits) in the double-blind treatment period will be eligible for participation in a 24-week open-label extension (OLE) study. A daily dose of 300 mg dazucorilant will be used in the 24-week OLE period.
Patients that complete the double-blind treatment period and who do not enter the OLE will enter the 24-week follow-up period.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||198 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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)|
|Actual Study Start Date :||November 15, 2022|
|Estimated Primary Completion Date :||May 2024|
|Estimated Study Completion Date :||November 2024|
Experimental: CORT113176 (Dazucorilant) 300 mg
300 mg of dazucorilant will be administered once daily.
Drug: Dazucorilant 300 mg
300 mg of dazucorilant will be administered once daily in 4 softgel capsules of 75 mg dazucorilant/capsule.
Experimental: CORT113176 (Dazucorilant) 150 mg
150 mg of dazucorilant will be administered once daily.
Drug: Dazucorilant 150 mg
Dazucorilant and placebo will be administered once daily in 4 softgel capsules, 2 capsules with 75 mg dazucorilant/capsule and 2 capsules of placebo equivalent.
Placebo Comparator: Placebo (matched to study drug)
Placebo will be administered once daily.
Placebo will be administered once daily in 4 softgel capsules of placebo equivalent.
- Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score. [ Time Frame: Baseline to Week 24 ]
- Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, AEs by severity, and deaths due to AEs. [ Time Frame: Baseline to Week 24 ]
- Change from Baseline to Week 24 in muscle strength (assessed using hand-held dynamometer). [ Time Frame: Baseline to Week 24 ]
- Change from Baseline to Week 24 in Percent Slow Vital Capacity [ Time Frame: Baseline to Week 24 ]
- Change from Baseline to Week 24 in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) [ Time Frame: Baseline to Week 24 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05407324
|Contact: Clinical Trial Lead||(650) firstname.lastname@example.org|
|Leuven, Belgium, 3000|
|Limoges, France, 87042|
|Marseille, France, 13385|
|Nice, France, 06001|
|Paris, France, 75651|
|Utrecht, Netherlands, 3584 CW|
|Bydgoszcz, Poland, 85-163|
|Warszawa, Poland, 01-684|
|Study Director:||Grace Mann, PhD||Corcept Therapeutics|
|Responsible Party:||Corcept Therapeutics|
|Other Study ID Numbers:||
2021-005611-31 ( EudraCT Number )
|First Posted:||June 7, 2022 Key Record Dates|
|Last Update Posted:||March 10, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
ALS, Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Nervous System Diseases
Spinal Cord Diseases
Central Nervous System Diseases