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

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.

Conditions

• Stroke
• Cerebral Infarction

Interventions

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

Sponsors & Collaborators

• Zhejiang Apeloa Jiayuan Pharmaceutical Co. Ltd.

  collaborator UNKNOWN

• Subei People's Hospital of Jiangsu Province

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• General Hospital of Shenyang Military Region

  collaborator OTHER

• The First Affiliated Hospital of BaoTou Medical College

  collaborator OTHER

• Xuanwu Hospital, Beijing

  collaborator OTHER

• Peking University First Hospital

  collaborator OTHER

• Peking University Third Hospital

  collaborator OTHER

• Tianjin First Central Hospital

  collaborator OTHER

• Tianjin Huanhu Hospital

  collaborator OTHER

• Hebei Medical University Third Hospital

  collaborator OTHER

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• Hebei General Hospital

  collaborator OTHER

• Second Hospital of Shanxi Medical University

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Qilu Hospital of Shandong University

  collaborator OTHER

• The First Affiliated Hospital of Soochow University

  collaborator OTHER

• Nanjing PLA General Hospital

  collaborator OTHER

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Shanghai Minhang Central Hospital

  collaborator OTHER

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• Guangzhou First People's Hospital

  collaborator OTHER

• Second Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• First Affiliated Hospital of Jinan University

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• The Central Hospital of Lishui City

  collaborator OTHER

• Shanghai Pudong New Area People's Hospital

  collaborator OTHER

• Inner Mongolia Baogang Hospital

  collaborator OTHER

• Daqing Oil Field Hospital

  collaborator OTHER

• Beijing Tiantan Hospital

  lead OTHER

Principal Investigators

• Meng Wang, MD, Ph.D · IRB of Beijing Tiantan Hospital, Capital Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-02

Primary Completion

2019-06-12

Completion

2019-12-13

Countries

• China

Study Locations