Dazucorilant in Patients With Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05407324
• Other study ID #: CORT113176-652
• Secondary ID: 2021-005611-31
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 15, 2022
• Est. completion date: May 2027

Study information

• Verified date: March 2024
• Source: Corcept Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 249
• Est. completion date: May 2027
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• Dazucorilant 300 mg
300 mg of dazucorilant will be administered once daily in 4 softgel capsules of 75 mg dazucorilant/capsule.
• 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.

Other:
• Placebo
Placebo will be administered once daily in 4 softgel capsules of placebo equivalent.

Locations

Country	Name	City	State
Belgium	108	Leuven
Canada	425	Hamilton	Ontario
Canada	273	Montréal	Quebec
France	422	Bron
France	258	Lille
France	257	Limoges
France	261	Marseille
France	423	Montpellier
France	259	Nice
France	262	Paris
France	256	Tours
Germany	255	Berlin
Germany	270	Bonn
Germany	268	Dresden
Germany	260	Hannover
Germany	265	Jena
Germany	386	München
Germany	267	Rostock
Germany	269	Ulm
Ireland	253	Dublin
Netherlands	264	Utrecht
Poland	283	Bydgoszcz
Poland	385	Kraków
Poland	254	Warszawa
Poland	274	Warszawa
Spain	115	Barcelona
Spain	302	Barcelona
Spain	303	Madrid
Spain	282	Málaga
Spain	194	Valencia
United Kingdom	263	Stoke on Trent
United States	287	Neptune	New Jersey
United States	353	New York	New York
United States	062	Phoenix	Arizona
United States	278	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Corcept Therapeutics

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany,  Ireland,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score.		Baseline to Week 24
Primary	Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, AEs by severity, and deaths due to AEs.		Baseline to Week 24
Secondary	Change from Baseline to Week 24 in muscle strength (assessed using hand-held dynamometer).		Baseline to Week 24
Secondary	Change from Baseline to Week 24 in Percent Slow Vital Capacity		Baseline to Week 24
Secondary	Change from Baseline to Week 24 in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)		Baseline to Week 24