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Dazucorilant in Patients With Amyotrophic Lateral Sclerosis (DAZALS)

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dazucorilant 300 mg
Dazucorilant 150 mg
Placebo
Sponsored by
Corcept Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring ALS, Amyotrophic Lateral Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

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.

Sites / Locations

  • 108Recruiting
  • 258Recruiting
  • 257Recruiting
  • 261Recruiting
  • 259Recruiting
  • 262Recruiting
  • 256Recruiting
  • 255Recruiting
  • 270Recruiting
  • 268Recruiting
  • 260Recruiting
  • 265Recruiting
  • 267Recruiting
  • 269Recruiting
  • 253Recruiting
  • 264Recruiting
  • 283Recruiting
  • 385Recruiting
  • 254Recruiting
  • 274Recruiting
  • 302Recruiting
  • 115Recruiting
  • 303Recruiting
  • 282Recruiting
  • 194Recruiting
  • 263Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

CORT113176 (Dazucorilant) 300 mg

CORT113176 (Dazucorilant) 150 mg

Placebo (matched to study drug)

Arm Description

300 mg of dazucorilant will be administered once daily.

150 mg of dazucorilant will be administered once daily.

Placebo will be administered once daily.

Outcomes

Primary Outcome Measures

Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score.
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, AEs by severity, and deaths due to AEs.

Secondary Outcome Measures

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
Change from Baseline to Week 24 in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)

Full Information

First Posted
June 2, 2022
Last Updated
September 22, 2023
Sponsor
Corcept Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05407324
Brief Title
Dazucorilant in Patients With Amyotrophic Lateral Sclerosis
Acronym
DAZALS
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corcept Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
ALS, Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CORT113176 (Dazucorilant) 300 mg
Arm Type
Experimental
Arm Description
300 mg of dazucorilant will be administered once daily.
Arm Title
CORT113176 (Dazucorilant) 150 mg
Arm Type
Experimental
Arm Description
150 mg of dazucorilant will be administered once daily.
Arm Title
Placebo (matched to study drug)
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered once daily.
Intervention Type
Drug
Intervention Name(s)
Dazucorilant 300 mg
Intervention Description
300 mg of dazucorilant will be administered once daily in 4 softgel capsules of 75 mg dazucorilant/capsule.
Intervention Type
Drug
Intervention Name(s)
Dazucorilant 150 mg
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered once daily in 4 softgel capsules of placebo equivalent.
Primary Outcome Measure Information:
Title
Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score.
Time Frame
Baseline to Week 24
Title
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 Measure Information:
Title
Change from Baseline to Week 24 in muscle strength (assessed using hand-held dynamometer).
Time Frame
Baseline to Week 24
Title
Change from Baseline to Week 24 in Percent Slow Vital Capacity
Time Frame
Baseline to Week 24
Title
Change from Baseline to Week 24 in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Time Frame
Baseline to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Lead
Phone
(650) 327-3270
Email
study652@corcept.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace Mann, PhD
Organizational Affiliation
Corcept Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
108
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
258
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
257
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Name
261
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Name
259
City
Nice
ZIP/Postal Code
06001
Country
France
Individual Site Status
Recruiting
Facility Name
262
City
Paris
ZIP/Postal Code
75651
Country
France
Individual Site Status
Recruiting
Facility Name
256
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Recruiting
Facility Name
255
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
270
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Name
268
City
Dresden
ZIP/Postal Code
1307
Country
Germany
Individual Site Status
Recruiting
Facility Name
260
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
265
City
Jena
ZIP/Postal Code
7747
Country
Germany
Individual Site Status
Recruiting
Facility Name
267
City
Rostock
ZIP/Postal Code
18147
Country
Germany
Individual Site Status
Recruiting
Facility Name
269
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Name
253
City
Dublin
ZIP/Postal Code
D09 YD60
Country
Ireland
Individual Site Status
Recruiting
Facility Name
264
City
Utrecht
ZIP/Postal Code
3584 CW
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
283
City
Bydgoszcz
ZIP/Postal Code
85-163
Country
Poland
Individual Site Status
Recruiting
Facility Name
385
City
Kraków
ZIP/Postal Code
30721
Country
Poland
Individual Site Status
Recruiting
Facility Name
254
City
Warszawa
ZIP/Postal Code
01-684
Country
Poland
Individual Site Status
Recruiting
Facility Name
274
City
Warszawa
ZIP/Postal Code
02-473
Country
Poland
Individual Site Status
Recruiting
Facility Name
302
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Name
115
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
303
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
282
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
194
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
263
City
Stoke on Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dazucorilant in Patients With Amyotrophic Lateral Sclerosis

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