GD-11 for Injection in the Treatment of Acute Ischemic Stroke - Trial NCT06299579
Access comprehensive clinical trial information for NCT06299579 through Pure Global AI's free database. This Phase 3 trial is sponsored by Beijing Tiantan Hospital and is currently Recruiting. The study focuses on Acute Ischemic Stroke. Target enrollment is 980 participants.
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Study Focus
Sponsor & Location
Beijing Tiantan Hospital
Timeline & Enrollment
Phase 3
Feb 29, 2024
Dec 31, 2025
Primary Outcome
Proportion of subjects with mRS score ≤1 on 90th day of treatment
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06299579
Non-Device Trial