Actively Recruiting
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
Eligibility Criteria
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
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
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
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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