Dazucorilant in Patients With Amyotrophic Lateral Sclerosis
Start Date
11/15/2022
Completion Date
11/1/2027
Summary
The purpose of this 2-part study is to assess the safety and efficacy of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (ALS).
Detailed Description
In Part 1, 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., complete 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 OLE period. Patients who complete the double-blind treatment period and who do not enter the OLE will enter the 132-week follow-up period. In Part 2, eligible ALS patients will receive open-label treatment to evaluate dose titration and tolerability of dazucorilant. The dose titration will begin with an initial 75 mg once daily dose, and the dose will be titrated up as tolerated in 75 mg increments until the 300 mg once daily target dose is reached and maintained for 3 weeks. Patients who complete participation in the dose-titration treatment period will be eligible to continue treatment with dazucorilant 300 mg once daily in a 52-week open-label extension portion of the study.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Dazucorilant 300 mg
Dazucorilant 150 mg
Placebo
Dazucorilant
Conditions
Locations
062
Phoenix, Arizona 85013
United States
278
San Francisco, California 94109
United States
287
Neptune City, New Jersey 07753
United States
353
New York, New York 10032
United States
108
Leuven, 3000
Belgium
425
Hamilton, Ontario L8N 3Z5
Canada
273
Montreal, Quebec H3A2B4
Canada
422
Bron, 69500
France
258
Lille, 59037
France
257
Limoges, 87042
France
261
Marseille, 13385
France
423
Montpellier, 42395
France
259
Nice, 06001
France
262
Paris, 75651
France
256
Tours, 37000
France
255
Berlin, 13353
Germany
270
Bonn, 53127
Germany
268
Dresden, 1307
Germany
260
Hanover, 30625
Germany
265
Jena, 7747
Germany
386
München, 81675
Germany
267
Rostock, 18147
Germany
269
Ulm, 89081
Germany
253
Dublin, D09 YD60
Ireland
264
Utrecht, 3584 CW
Netherlands
283
Bydgoszcz, 85-163
Poland
385
Krakow, 30721
Poland
254
Warsaw, 01-684
Poland
274
Warsaw, 02-473
Poland
302
Barcelona, 08003
Spain
115
Barcelona, 08035
Spain
303
Madrid, 28046
Spain
282
Málaga, 29010
Spain
194
Valencia, 46026
Spain
263
Stoke-on-Trent, ST4 6QG
United Kingdom