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GD-11 for Injection in the Treatment of Acute Ischemic Stroke
Phase III Clinical Trial of GD-11 for Injection in the Treatment of Acute Ischemic Stroke - A Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase III Clinical Study with the primary objective of evaluation of the efficacy and safety of GD-11 for injection in the treatment of acute ischemic stroke patients within 48 hours. The subject has a clinical diagnosis of acute ischemic stroke, within 48 hours from stroke onset to start of study treatment, with a National Institutes of Health Stroke Scale (NIHSS) between 6 and 20, had a total score of upper and lower limbs on motor deficits ≥ 2. The primary outcome is the proportion of subjects with mRS score ≤ 1 at 90 days after treatment.
Details
| Lead sponsor | Beijing Tiantan Hospital |
|---|---|
| Phase | PHASE3 |
| Status | UNKNOWN |
| Enrolment | 980 |
| Start date | Thu Feb 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed Dec 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Acute Ischemic Stroke
Interventions
- GD-11 for injection test group
- Placebo control group
Countries
China