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Dazucorilant in Patients With Amyotrophic Lateral Sclerosis (DAZALS)

Corcept Therapeutics logo

Corcept Therapeutics

Status and phase

Active, not recruiting
Phase 2

Conditions

Amyotrophic Lateral Sclerosis

Treatments

Drug: Dazucorilant 300 mg
Other: Placebo
Drug: Dazucorilant 150 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT05407324
2021-005611-31 (EudraCT Number)
CORT113176-652

Details and patient eligibility

About

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

Full 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.

Enrollment

249 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

249 participants in 3 patient groups, including a placebo group

CORT113176 (Dazucorilant) 300 mg
Experimental group
Description:
300 mg of dazucorilant will be administered once daily.
Treatment:
Drug: Dazucorilant 300 mg
CORT113176 (Dazucorilant) 150 mg
Experimental group
Description:
150 mg of dazucorilant will be administered once daily.
Treatment:
Drug: Dazucorilant 150 mg
Placebo (matched to study drug)
Placebo Comparator group
Description:
Placebo will be administered once daily.
Treatment:
Other: Placebo

Trial contacts and locations

35

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Central trial contact

Clinical Trial Lead

Data sourced from clinicaltrials.gov

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