Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05407324 | Dazucorilant in Patients With Amyotrophic Lateral Sclerosis | PHASE2 | RECRUITING | 279 | — | — | Nov 15, 2022 | Nov 1, 2027 | Mar 30, 2026 | 35 | United States, Belgium +8 |
This outcome measure is assessed in study Part 1.
This outcome measure is assessed in study Part 1.
This outcome measure is assessed in study Part 2.
This outcome measure is assessed in study Part 2.
| Arm | Type | Description |
|---|---|---|
| Part 1: CORT113176 (Dazucorilant) 300 mg | EXPERIMENTAL | 300 mg of dazucorilant will be administered once daily. |
| Part 1: CORT113176 (Dazucorilant) 150 mg | EXPERIMENTAL | 150 mg of dazucorilant will be administered once daily. |
| Part 1: Placebo (matched to study drug) | PLACEBO_COMPARATOR | Placebo will be administered once daily. |
| Part 2: CORT113176 (Dazucorilant) 75 - 300 mg Dose-titration | EXPERIMENTAL | 75 mg of dazucorilant will be administered once daily for 1 week, and increased weekly in 75 mg increments up to 300 mg once daily. |
| Name | Type | Description |
|---|---|---|
| Dazucorilant 300 mg | DRUG | 300 mg of dazucorilant will be administered once daily in 4 capsules of 75 mg dazucorilant/capsule. |
| Dazucorilant 150 mg | DRUG | Dazucorilant and placebo will be administered once daily in 4 capsules, 2 capsules with 75 mg dazucorilant/capsule, and 2 capsules of placebo equivalent. |
| Placebo | OTHER | Placebo will be administered once daily in capsules of placebo equivalent. |
| Dazucorilant | DRUG | Dazucorilant will be administered once daily in 75-mg capsules. |
Inclusion Criteria: * Male and female patients ≥18 years of age with Sporadic or familial ALS. In Part 1, patients must have a risk of ALS progression characterized by a European Network for the Cure of ALS (ENCALS) risk profile score ≥ -6 and ≤ -3. In Part 2 patients must have a risk of ALS progre...