Pure Global
NCT06299579

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
Beijing Tiantan Hospital·Phase 3·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Acute Ischemic Stroke
Drug/Device/Intervention
GD-11 for injection test group
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Beijing Tiantan Hospital
Location
Beijing,Shangxi, China
Timeline & enrollment
Phase
Phase 3
Start date
Feb 29, 2024
End date
Dec 31, 2025
Enrollment
980 participants
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
Stroke, not specified as haemorrhage or infarctionSequelae of stroke, not specified as haemorrhage or infarctionCerebral infarctionCerebral infarction, unspecifiedTransient cerebral ischaemic attack, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06299579
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.