Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05407324

Dazucorilant in Patients With Amyotrophic Lateral Sclerosis

Led by Corcept Therapeutics · Updated on 2026-03-30

279

Participants Needed

35

Research Sites

258 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Dazucorilant in Patients With Amyotrophic Lateral Sclerosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female patients 18 years of age or older with sporadic or familial ALS
  • Part 1: ALS progression risk with ENCALS risk profile score between -6 and -3
  • Part 2: ALS progression risk with ENCALS risk profile score between -7 and -3
  • Stable dose of riluzole, edaravone, and/or sodium phenylbutyrate and taurursodiol before screening (sodium phenylbutyrate and taurursodiol not allowed in Part 2)
  • Part 2 only: Patients with SOD1 mutation not receiving or eligible for tofersen; prior tofersen treatment allowed if stopped for safety or efficacy reasons
  • Part 2 only: Use of ultra high-dose methylcobalamin allowed if stable for at least 11 weeks before Day 1 visit
Not Eligible

You will not qualify if you...

  • History of clinically significant neurologic disorders other than ALS
  • Inability to swallow capsules
  • Blood platelet count below 150,000/mm^3
  • Renal impairment with eGFR below 30 mL/min/1.73 m^2; Part 2 only: recent acute kidney injury not resolved
  • HIV infection or chronic/active hepatitis B or C infection; Part 2 only: known history without need for testing if unknown
  • Women who are pregnant, planning pregnancy, or breastfeeding
  • Use of non-invasive ventilation, mechanical ventilation via tracheostomy, or oxygen supplementation
  • Current or expected need for a diaphragm pacing system
  • Current or history of regular systemic glucocorticoid use within the last 12 months
  • Previous exposure or treatment with glucocorticoid receptor modulators or antagonists

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 35 locations

1

062

Phoenix, Arizona, United States, 85013

Actively Recruiting

2

278

San Francisco, California, United States, 94109

Actively Recruiting

3

287

Neptune City, New Jersey, United States, 07753

Actively Recruiting

4

353

New York, New York, United States, 10032

Actively Recruiting

5

108

Leuven, Belgium, 3000

Active, Not Recruiting

6

425

Hamilton, Ontario, Canada, L8N 3Z5

Active, Not Recruiting

7

273

Montreal, Quebec, Canada, H3A2B4

Active, Not Recruiting

8

422

Bron, France, 69500

Active, Not Recruiting

9

258

Lille, France, 59037

Active, Not Recruiting

10

257

Limoges, France, 87042

Active, Not Recruiting

11

261

Marseille, France, 13385

Active, Not Recruiting

12

423

Montpellier, France, 42395

Active, Not Recruiting

13

259

Nice, France, 06001

Active, Not Recruiting

14

262

Paris, France, 75651

Active, Not Recruiting

15

256

Tours, France, 37000

Active, Not Recruiting

16

255

Berlin, Germany, 13353

Active, Not Recruiting

17

270

Bonn, Germany, 53127

Active, Not Recruiting

18

268

Dresden, Germany, 1307

Active, Not Recruiting

19

260

Hanover, Germany, 30625

Active, Not Recruiting

20

265

Jena, Germany, 7747

Active, Not Recruiting

21

386

München, Germany, 81675

Active, Not Recruiting

22

267

Rostock, Germany, 18147

Active, Not Recruiting

23

269

Ulm, Germany, 89081

Active, Not Recruiting

24

253

Dublin, Ireland, D09 YD60

Active, Not Recruiting

25

264

Utrecht, Netherlands, 3584 CW

Active, Not Recruiting

26

283

Bydgoszcz, Poland, 85-163

Active, Not Recruiting

27

385

Krakow, Poland, 30721

Active, Not Recruiting

28

254

Warsaw, Poland, 01-684

Active, Not Recruiting

29

274

Warsaw, Poland, 02-473

Active, Not Recruiting

30

302

Barcelona, Spain, 08003

Active, Not Recruiting

31

115

Barcelona, Spain, 08035

Active, Not Recruiting

32

303

Madrid, Spain, 28046

Active, Not Recruiting

33

282

Málaga, Spain, 29010

Active, Not Recruiting

34

194

Valencia, Spain, 46026

Active, Not Recruiting

35

263

Stoke-on-Trent, United Kingdom, ST4 6QG

Active, Not Recruiting

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Research Team

C

Clinical Trial Lead

CONTACT

C

Corcept Therapeutics Incorporated

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Dazucorilant in Patients With Amyotrophic Lateral Sclerosis | DecenTrialz