Compound Edaravone Injection for Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

Official title:

Compound Edaravone Injection for Acute Ischemic Stroke, a Multi-center, Randomized, Double-blind, Multi-dose, Parallel, and Controlled Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929096
• Other study ID #: SIM-23-01
• Status: Completed
• Phase: Phase 2
• First received: August 22, 2013
• Last updated: July 1, 2015
• Start date: August 2013
• Est. completion date: February 2015

Study information

• Verified date: July 2015
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

1. To investigate the efficacy and safety of multi-doses Compound Edaravone Injection versus Edaravone Injection for acute ischemic stroke patients;

2. To provide evidence for the design of Compound Edaravone Injection Phase III trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• Hospitalized patients, diagnosed of ischemic stroke;

• 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:

• Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage;

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Stroke

Intervention

Drug:
• Compound Edaravone Injection

• Edaravone Injection

Locations

Country	Name	City	State
China	Central Hospital of Baotou	Baotou	Inner Mongolia
China	Beijing Tiantan Hospital affiliated to Capital Medical University	Beijing	Beijing
China	Navy General Hospital of The Chinese PLA	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	Hunan Provincial People's Hospital	Changsha	Hunan
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The First Affiliated Hospital of Third Military Medical University of Chinese PLA	Chongqing	Chongqing
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Haerbin Medical University	Haerbin	Heilongjiang
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	The Second Hospital of Shandong University	Jinan	Shandong
China	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	Nanjing Brain Hospital	Nanjing	Jiangsu
China	Nanjing First Hospital	Nanjing	Jiangsu
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Qingdao Municipal Hospital	Qingdao	Shandong
China	Rui Jin Hospital Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shanghai Changzheng Hospital	Shanghai	Shanghai
China	The General Hospital of Shenyang Military, Chinese PLA	Shenyang	Liaoning
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong
China	Hebei General Hospital	Shijiazhuang	Hebei
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The First Affiliated Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	The Second Affiliated Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Tianjin Huanhu Hospital	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Tianjin People's Hospital	Tianjin	Tianjin
China	The Affiliated Hospital of Xuzhou Medical College	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mRS score on day 90		day 90	No
Primary	Change from baseline NIHSS score on day 14		day 14	No
Secondary	The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90		day 14, 30, 90	No
Secondary	The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90		day 14, 30, 90	No
Secondary	The Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90		day 14, 30, 90	No
Secondary	Stroke Impact Scale (SIS) score on day 90		day 90	No