Phase 2, multicenter, randomized, double-blind, placebo-controlled study
Topic / Pathology
- SLA
- Phase 2
Objectives
Primary objective :
The purpose of this study is to assess the safety and efficacy of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (ALS).
Secondary objectives :
To evaluate the effect of CORT113176 on :
1. Muscular strength
2. Quality of life and function scales
3. Time to event for patients involved in the following events:
- Hospitalization due to an ALS-related event or condition
- Full-time or near-full-time respiratory assistance
- Tracheostomy procedure
- Death.
4. Combined assessment of function and survival (CAFS)
5. Evaluate the pharmacokinetics (PK) of CORT113176 in patients with ALS
6. Evaluate ALS-related biomarkers
7. Evaluate other patient-reported outcomes
Find out more : https://clinicaltrials.gov/ct2/show/NCT05407324
Patients who complete their visits during the double-blind treatment period will be eligible to participate in a 24-week open-label extension (OLE) study. A daily dose of 300 mg dazucorilant will be used during the 24-week OLE period.
Patients who complete the double-blind treatment period and do not participate in the OLE study will enter the 24-week follow-up period.
Sponsor
Corcept Therapeutics
Investigator
National coordinator : Pr Gaëlle Bruneteau
Status
Active not recruiting
