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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05006352 | A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis | PHASE1 | COMPLETED | 29 | — | — | Aug 11, 2021 | Jun 5, 2024 | Sep 19, 2024 | 7 | United States, Netherlands |
| Arm | Type | Description |
|---|---|---|
| DNL343 (High Dose) | EXPERIMENTAL | - |
| DNL343 (Low Dose) | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| DNL343 | DRUG | Oral repeating dose |
| Placebo | DRUG | Oral repeating dose |
Key Inclusion Criteria: * Diagnosis of sporadic or familial ALS * ≤ 4 years since ALS symptom onset * Stable doses of approved ALS treatments (riluzole and/or edaravone) for at least 2 months prior to screening * Participants must be able to swallow the study intervention * Vital capacity \>50% pre...