Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
400 participants
INTERVENTIONAL
2013-08-31
2015-02-28
Brief Summary
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2. To provide evidence for the design of Compound Edaravone Injection Phase III trial.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low-dose group
Compound Edaravone Injection, 12.5mg/dose (Edaravone 10mg, (+)-Borneol 2.5mg), one dose every 12 hours, continue for 14 days
Compound Edaravone Injection
Medium-dose group
Compound Edaravone Injection, 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days
Compound Edaravone Injection
High-dose group
Compound Edaravone Injection, 62.5mg/dose (Edaravone 50mg, (+)-Borneol 12.5mg), one dose every 12 hours, continue for 14 days
Compound Edaravone Injection
Control group
Edaravone Injection，30 mg/dose, one dose every 12 hours, continues for 14 days
Edaravone Injection
Interventions
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Compound Edaravone Injection
Edaravone Injection
Eligibility Criteria
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Inclusion Criteria
* Onset of stroke is less than or equal to 48 hours;
* There are clear signs of neurological deficit: 4≤NIHSS score≤24, and also, the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2;
* Patients signed written inform consent.
Exclusion Criteria
* Iatrogenic stroke;
* Severe disturbance of consciousness: NIHSS category 1a for consciousness is greater than 1；
* The mRS score prior to this onset is greater than 1;
* Transient ischemic attack (TIA);
* SBP after blood pressure control is still greater than to equal to 220 mmHg, or DBP after blood pressure control is still greater than or equal to 120 mmHg;
* Patients with severe mental disorders and dementia;
* ALT or AST is greater than 2.0×ULN or previously known liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis;
* Creatinine clearance is less than 30 ml/min or previously known severe renal diseases;
* Therapeutic neuroprotective agents have been applied after onset, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase;
* Arterial or venous thrombolytic therapy has been applied after onset;
* With malignant tumors or receiving concurrent antitumor treatment;
* With severe systemic disease, life expectancy is less than 90 days;
* Pregnant or lactating women;
* Participate in other clinical studies within 30 days before randomization;
* The investigators consider the patients are not suitable for this trial.
35 Years
75 Years
ALL
No
Sponsors
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Jiangsu Simcere Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yongjun Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Locations
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Navy General Hospital of The Chinese PLA
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Third Military Medical University of Chinese PLA
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Hebei General Hospital
Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Haerbin Medical University
Haerbin, Heilongjiang, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Central Hospital of Baotou
Baotou, Inner Mongolia, China
Nanjing First Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Nanjing Brain Hospital
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
The General Hospital of Shenyang Military, Chinese PLA
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
The Second Hospital of Shandong University
Jinan, Shandong, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
The Second Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China
Countries
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References
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Xu J, Wang Y, Wang A, Gao Z, Gao X, Chen H, Zhou J, Zhao X, Wang Y. Safety and efficacy of Edaravone Dexborneol versus edaravone for patients with acute ischaemic stroke: a phase II, multicentre, randomised, double-blind, multiple-dose, active-controlled clinical trial. Stroke Vasc Neurol. 2019 Apr 22;4(3):109-114. doi: 10.1136/svn-2018-000221. eCollection 2019 Sep.
Other Identifiers
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SIM-23-01
Identifier Type: -
Identifier Source: org_study_id
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