Dazucorilant in Patients With Amyotrophic Lateral Sclerosis

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Corcept Therapeutics
Study ID
NCT05407324
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dazucorilant 300 mg — DRUG
    300 mg of dazucorilant will be administered once daily in 4 capsules of 75 mg dazucorilant/capsule.
  • Dazucorilant 150 mg — DRUG
    Dazucorilant and placebo will be administered once daily in 4 capsules, 2 capsules with 75 mg dazucorilant/capsule, and 2 capsules of placebo equivalent.
  • Placebo — OTHER
    Placebo will be administered once daily in capsules of placebo equivalent.
  • Dazucorilant — DRUG
    Dazucorilant will be administered once daily in 75-mg capsules.

Study Details

The purpose of this 2-part study is to assess the safety and efficacy of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (ALS).

Key Dates

Start date
Nov 15, 2022
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
279 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: CORT113176 (Dazucorilant) 300 mg
    300 mg of dazucorilant will be administered once daily.
  • Experimental: Part 1: CORT113176 (Dazucorilant) 150 mg
    150 mg of dazucorilant will be administered once daily.
  • Placebo Comparator: Part 1: Placebo (matched to study drug)
    Placebo will be administered once daily.
  • Experimental: Part 2: CORT113176 (Dazucorilant) 75 - 300 mg Dose-titration
    75 mg of dazucorilant will be administered once daily for 1 week, and increased weekly in 75 mg increments up to 300 mg once daily.

Primary Outcome Measure

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

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
062PhoenixArizona85013-
278San FranciscoCalifornia94109-
287Neptune CityNew Jersey07753-
353New YorkNew York10032-

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