Phase III Clinical Trial of 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.
⁃ Only those who meet all of the following items will be enrolled:
• age ≥18 years and \<81 years, male or female;
• National Institutes of Health Stroke Scale (NIHSS) score: 6 ≤ NIHSS ≤ 20, and the sum of item 5 Upper Extremity and item 6 Lower Extremity scores ≥ 2 after the onset of this event;
• The onset of the disease is within 48 hours (including 48 hours);
• Patients who are diagnosed with ischemic stroke according to the requirements of the latest guidelines such as Diagnostic Points of Various Major Cerebrovascular Diseases in China 2019 or Clinical Management Guidelines of Cerebrovascular Diseases in China (2nd edition), and who have a good healing after the first onset or the last onset (mRS score ≤1 before this onset);
• Obtaining informed consent approved by the Ethics Committee voluntarily signed by the patients or their legal representatives.