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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 980 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 81 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A multicenter, randomized, double-blind, parallel, placebo-controlled trial design was used. Subjects were randomly assigned in a 1:1 ratio to the experimental group (GD-11 for injection treatment group) and the control group (GD-11 for injection placebo group). Randomization stratification factors included onset time (≤24 hours, \>24 hours) and center.Continuous treatment was performed for 10 days (20 times), followed up to 90 days after the first administration. The trial was divided into three phases: screening/baseline phase, treatment phase, and follow-up phase. Screening/baseline phase: Subjects entered the screening/baseline phase after signing the informed consent for screening examinations. Treatment phase: Eligible subjects were randomly assigned in a 1:1 ratio to receive GD-11 for injection or placebo for injection for 10 days (20 times). During the treatment, protocol-required examinations were performed and safety was evaluated. Follow-up phase: Subjects who completed the treatment entered the follow-up phase and were followed up to 90 days after the first administration. Stroke-related scale scores were performed on the 10th, 30th, and 90th days after the first use of the test drug. Adverse events were recorded during the treatment and follow-up phases to further evaluate safety.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	GD-11 for injection test group	The first dose of GD-11 was administered as soon as possible after randomization and then every 12±1 hour. A total of 20 doses were required.
DRUG	Placebo control group	The first dose of placebo was administered as soon as possible after randomization and then every 12±1 hour. A total of 20 doses were required.

Timeline

• Start date: 2024-02-29
• Primary completion: 2025-02-22
• Completion: 2025-12-31
• First posted: 2024-03-08
• Last updated: 2024-03-15

Locations

2 sites across 1 country: China