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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07410806 | HEALEY ALS Platform Trial - Regimen I NUZ-001 | PHASE2 | ENROLLING BY_INVITATION | 160 | — | — | Feb 16, 2026 | Aug 1, 2028 | Feb 17, 2026 | 1 | United States |
Change in disease severity over time as measured by the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) total score and survival. Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function.
| Arm | Type | Description |
|---|---|---|
| NUZ-001 | EXPERIMENTAL | NUZ-001 |
| Matching Placebo | PLACEBO_COMPARATOR | Placebo Comparator: Matching Placebo |
| Name | Type | Description |
|---|---|---|
| NUZ-001 | DRUG | NUZ-001 is administered orally once daily for 36 weeks. |
| Matching placebo | DRUG | Matching placebo is administered orally once daily for 36 weeks. |
Inclusion Criteria: * No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT NCT04297683). Exclusion Criteria: * The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683). 1. Clini...