NCT04486430

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 236 (actual)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Stroke
• Cerebral Infarction

Interventions

Type	Name	Description
DRUG	Neu2000KWL	1st infusion of 500mg in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of 250 mg at intervals of 12 hours
DRUG	Neu2000KWL	1st infusion of 750mg in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of 500 mg at intervals of 12 hours
DRUG	Neu2000KWL	1st infusion of 1500mg in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of 500 mg at intervals of 12 hours
DRUG	Placebos	1st infusion of the same volume of saline in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of the same volume of saline at intervals of 12 hours

Timeline

• Start date: 2017-03-02
• Primary completion: 2019-06-12
• Completion: 2019-12-13
• First posted: 2020-07-24
• Last updated: 2020-07-24

Locations

1 site across 1 country: China