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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04950920 | Phase III Clinical Trial of Y-2 Sublingual Tablets in the Treatment of Acute Ischemic Stroke | PHASE3 | COMPLETED | 914 | — | — | Jun 28, 2021 | Nov 14, 2022 | Aug 22, 2023 | 1 | China |
Whether patients with mRS(Modified Rankin Scale) score ≤ 1. Used to calculate the proportion of patients with mRS score ≤ 1.
| Arm | Type | Description |
|---|---|---|
| Y-2 sublingual test group | EXPERIMENTAL | Y-2 sublingual tablets: Edaravone 30mg and d-borneol 6mg. |
| placebo group | SHAM_COMPARATOR | 60 μg d-borneol |
| Name | Type | Description |
|---|---|---|
| Y-2 sublingual tablets | DRUG | 30mg Edaravone+6mg d-borneo OR， Bid |
| d-borneol | DRUG | 60 μg d-borneol OR， Bid |
Inclusion Criteria: \- Those who meet all of the following requirements: 1. Age ≥ 18 years old and ≤ 80 years old, regardless of gender; 2. After the onset of the disease, the National Institutes of Stroke Scale score: 6 ≤ NIHSS ≤ 20, and the sum of the fifth upper limb score and the sixth lower ...