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Dazucorilant in Patients With Amyotrophic Lateral Sclerosis (DAZALS)

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ClinicalTrials.gov Identifier: NCT05407324
Recruitment Status : Active, not recruiting
First Posted : June 7, 2022
Last Update Posted : April 26, 2024
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics

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

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: Dazucorilant 300 mg Drug: Dazucorilant 150 mg Other: Placebo Phase 2

Detailed Description:

Eligible ALS patients will be randomized to one of three treatment arms (1:1:1) across North America and Europe for a 24-week double-blind treatment period.

Patients who complete participation (i.e., completed all visits) in the double-blind treatment period will be eligible for participation in a 132-week open-label extension (OLE) study. A daily dose of 300 mg dazucorilant will be used in the 132-week OLE period.

Patients that complete the double-blind treatment period and who do not enter the OLE will enter the 132-week follow-up period.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 : October 2024
Estimated Study Completion Date : May 2027

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Arms and Interventions
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Arm Intervention/treatment
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.
 Other: Placebo
Placebo will be administered once daily in 4 softgel capsules of placebo equivalent.


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score. [ Time Frame: Baseline to Week 24 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Change from Baseline to Week 24 in muscle strength (assessed using hand-held dynamometer). [ Time Frame: Baseline to Week 24 ]
  2. Change from Baseline to Week 24 in Percent Slow Vital Capacity [ Time Frame: Baseline to Week 24 ]
  3. Change from Baseline to Week 24 in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) [ Time Frame: Baseline to Week 24 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients ≥18 years of age with Sporadic or familial ALS
  • If taking riluzole, edaravone, and/or sodium phenylbutyrate and taurursodiol, 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Corcept Therapeutics
Investigators
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Study Director: Grace Mann, PhD Corcept Therapeutics
More Information
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Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT05407324    
Other Study ID Numbers: CORT113176-652
2021-005611-31 ( EudraCT Number )
First Posted: June 7, 2022    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Corcept Therapeutics:
ALS, Amyotrophic Lateral Sclerosis
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases