Efficacy and Safety Study of Neu2000KWL for Acute Ischemic Stroke Patients Within 6 Hours of Onset — Salfaprodil  

Stroke Clinical Trial

Official title: A Phase II, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of the Salfaprodil for Injection in Patients With Acute Ischemic Stroke

Status Completed

Clinical Trial Summary

The purpose of the study is to explore safety and efficacy of Salfaprodil administration for patients with acute ischemic stroke within 6 hours of onset.

Clinical Trial Description

The present study is to investigate safety and efficacy of Neu2000, a multi-target neuroprotectant acting as a moderate NR2B-selective NMDA receptor antagonist and potent antioxidant, in acute ischemic stroke patients within 6 hours of onset. Compared to NMDA antagonists or antioxidants, improved efficacy and therapeutic time window of Neu2000 have been well documented in four animal models of stroke. Notable Safety of Neu2000 has been demonstrated in 168 human subjects conducted in the US and China as well as animals.

In the present phase II study, patients with acute ischemic stroke within 6 hours of onset would be assigned randomly to one of four groups as follows:

• Group A receiving 2.75g Neu2000KWL for 5 days

• Group B receiving 5.25g Neu2000KWL for 5 days

• Group C receiving 6.00g Neu2000KWL for 5 days

• Group D receiving placebo for 5 days

Patients will receive intravenous infusion of the clinical study drug twice a day at 12±1 hour intervals for 5 days. ;

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction
• Stroke

• NCT number: NCT04486430
• Study type: Interventional
• Source: Beijing Tiantan Hospital
• Status: Completed
• Phase: Phase 2
• Start date: March 2, 2017
• Completion date: December 13, 2019