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

PHASE2CompletedINTERVENTIONAL
Enrollment

236

Participants

Timeline

Start Date

March 2, 2017

Primary Completion Date

June 12, 2019

Study Completion Date

December 13, 2019

Conditions
StrokeCerebral 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

Trial Locations (1)

100050

Beijing Stroke Association, Beijing

All Listed Sponsors
collaborator

Zhejiang Apeloa Jiayuan Pharmaceutical Co. Ltd.

UNKNOWN

collaborator

Subei People's Hospital of Jiangsu Province

OTHER

collaborator

The First Hospital of Jilin University

OTHER

collaborator

First Hospital of China Medical University

OTHER

collaborator

General Hospital of Shenyang Military Region

OTHER

collaborator

The First Affiliated Hospital of BaoTou Medical College

OTHER

collaborator

Xuanwu Hospital, Beijing

OTHER

collaborator

Peking University First Hospital

OTHER

collaborator

Peking University Third Hospital

OTHER

collaborator

Tianjin First Central Hospital

OTHER

collaborator

Tianjin Huanhu Hospital

OTHER

collaborator

Hebei Medical University Third Hospital

OTHER

collaborator

The Second Hospital of Hebei Medical University

OTHER

collaborator

Hebei General Hospital

OTHER

collaborator

Second Hospital of Shanxi Medical University

OTHER

collaborator

Shandong Provincial Hospital

OTHER_GOV

collaborator

Qilu Hospital of Shandong University

OTHER

collaborator

The First Affiliated Hospital of Soochow University

OTHER

collaborator

Nanjing PLA General Hospital

OTHER

collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

collaborator

Shanghai Minhang Central Hospital

OTHER

collaborator

First Affiliated Hospital of Zhejiang University

OTHER

collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

collaborator

Xiangya Hospital of Central South University

OTHER

collaborator

Guangzhou First People's Hospital

OTHER

collaborator

Second Affiliated Hospital of Guangzhou Medical University

OTHER

collaborator

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

OTHER

collaborator

Nanfang Hospital, Southern Medical University

OTHER

collaborator

First Affiliated Hospital of Jinan University

OTHER

collaborator

Tongji Hospital

OTHER

collaborator

The Central Hospital of Lishui City

OTHER

collaborator

Shanghai Pudong New Area People's Hospital

OTHER

collaborator

Inner Mongolia Baogang Hospital

OTHER

collaborator

Daqing Oil Field Hospital

OTHER

lead

Beijing Tiantan Hospital

OTHER

NCT04486430 - Efficacy and Safety Study of Neu2000KWL for Acute Ischemic Stroke Patients Within 6 Hours of Onset | Biotech Hunter | Biotech Hunter