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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05357950 | A Phase IIb, Multi-Center, Multinational, Double-Blind, Placebo-Controlled Study, With an Open Label Extension, to Evaluate Safety, Tolerability and Efficacy of PrimeC in Subjects With ALS | PHASE2 | COMPLETED | 69 | — | — | May 31, 2022 | Nov 4, 2024 | Sep 5, 2025 | 4 | Canada, Israel +1 |
Treatment emergent adverse event is any medical event associated with the drug
Number of subjects whose treatment is stopped prematurely for any reason
Number of patients whose treatment is stopped prematurely specifically due to adverse events
| Arm | Type | Description |
|---|---|---|
| PrimeC | ACTIVE_COMPARATOR | 2 tablets of PrimeC administered twice daily (4 tablets a day), at a daily dose of 1496 mg |
| Placebo | PLACEBO_COMPARATOR | 2 tablets of Placebo administered twice daily (4 tablets a day). Placebo tablets are matched in size, color and taste. |
| Name | Type | Description |
|---|---|---|
| PrimeC | DRUG | Ciprofloxacin and celecoxib combination extended release formulation |
| Placebo | DRUG | Placebo matches active drug in size, color and taste |
Inclusion Criteria: 1. Able to comprehend and willing to sign an informed consent form (ICF) 2. Males or females between the ages of 18 and 75 years of age, inclusive 3. Diagnosis of familial or sporadic ALS (defined as meeting the laboratory-supported probable, probable, or definite criteria for a...