Dazucorilant in Patients With Amyotrophic Lateral Sclerosis
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- Registration Number
- NCT05407324
- Lead Sponsor
- Corcept Therapeutics
- Brief Summary
The purpose of this study is to assess the safety and efficacy of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (ALS).
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 249
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CORT113176 (Dazucorilant) 150 mg Dazucorilant 150 mg 150 mg of dazucorilant will be administered once daily. CORT113176 (Dazucorilant) 300 mg Dazucorilant 300 mg 300 mg of dazucorilant will be administered once daily. Placebo (matched to study drug) Placebo Placebo will be administered once daily.
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, AEs by severity, and deaths due to AEs. Baseline to Week 24 Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score. Baseline to Week 24
- Secondary Outcome Measures
Name Time Method Change from Baseline to Week 24 in Percent Slow Vital Capacity Baseline to Week 24 Change from Baseline to Week 24 in muscle strength (assessed using hand-held dynamometer). Baseline to Week 24 Change from Baseline to Week 24 in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Baseline to Week 24
Trial Locations
- Locations (35)
425
🇨🇦Hamilton, Ontario, Canada
261
🇫🇷Marseille, France
108
🇧🇪Leuven, Belgium
265
🇩🇪Jena, Germany
303
🇪🇸Madrid, Spain
278
🇺🇸San Francisco, California, United States
256
🇫🇷Tours, France
255
🇩🇪Berlin, Germany
422
🇫🇷Bron, France
062
🇺🇸Phoenix, Arizona, United States
287
🇺🇸Neptune, New Jersey, United States
353
🇺🇸New York, New York, United States
273
🇨🇦Montréal, Quebec, Canada
258
🇫🇷Lille, France
423
🇫🇷Montpellier, France
257
🇫🇷Limoges, France
259
🇫🇷Nice, France
262
🇫🇷Paris, France
268
🇩🇪Dresden, Germany
270
🇩🇪Bonn, Germany
260
🇩🇪Hannover, Germany
283
🇵🇱Bydgoszcz, Poland
386
🇩🇪München, Germany
267
🇩🇪Rostock, Germany
269
🇩🇪Ulm, Germany
253
🇮🇪Dublin, Ireland
264
🇳🇱Utrecht, Netherlands
385
🇵🇱Kraków, Poland
274
🇵🇱Warszawa, Poland
302
🇪🇸Barcelona, Spain
254
🇵🇱Warszawa, Poland
194
🇪🇸Valencia, Spain
115
🇪🇸Barcelona, Spain
282
🇪🇸Málaga, Spain
263
🇬🇧Stoke on Trent, United Kingdom