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Compound Edaravone Injection for Acute Ischemic Stroke

Primary Purpose

Acute Ischemic Stroke

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Compound Edaravone Injection
Edaravone Injection
Sponsored by
Jiangsu Simcere Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Navy General Hospital of The Chinese PLA
  • Beijing Tiantan Hospital affiliated to Capital Medical University
  • Peking University Third Hospital
  • The First Affiliated Hospital of Chongqing Medical University
  • The First Affiliated Hospital of Third Military Medical University of Chinese PLA
  • The First Affiliated Hospital of Sun Yat-sen University
  • Peking University Shenzhen Hospital
  • The Second Hospital of Hebei Medical University
  • Hebei General Hospital
  • The Second Affiliated Hospital of Haerbin Medical University
  • Hunan Provincial People's Hospital
  • Central Hospital of Baotou
  • Nanjing First Hospital
  • The Second Affiliated Hospital of Nanjing Medical University
  • Nanjing Brain Hospital
  • The Affiliated Hospital of Xuzhou Medical College
  • Jiangxi Provincial People's Hospital
  • The General Hospital of Shenyang Military, Chinese PLA
  • Qilu Hospital of Shandong University
  • The Second Hospital of Shandong University
  • Qingdao Municipal Hospital
  • Shanghai Changzheng Hospital
  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
  • The First Affiliated Hospital of Shanxi Medical University
  • The Second Affiliated Hospital of Shanxi Medical University
  • Tianjin People's Hospital
  • Tianjin Medical University General Hospital
  • Tianjin Huanhu Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Low-dose group

Medium-dose group

High-dose group

Control group

Arm Description

Compound Edaravone Injection, 12.5mg/dose (Edaravone 10mg, (+)-Borneol 2.5mg), one dose every 12 hours, continue for 14 days

Compound Edaravone Injection, 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days

Compound Edaravone Injection, 62.5mg/dose (Edaravone 50mg, (+)-Borneol 12.5mg), one dose every 12 hours, continue for 14 days

Edaravone Injection，30 mg/dose, one dose every 12 hours, continues for 14 days

Outcomes

Primary Outcome Measures

mRS score on day 90
Change from baseline NIHSS score on day 14

Secondary Outcome Measures

The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90
The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90
The Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90
Stroke Impact Scale (SIS) score on day 90

Full Information

First Posted
August 22, 2013
Last Updated
July 1, 2015
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01929096
Brief Title
Compound Edaravone Injection for Acute Ischemic Stroke
Official Title
Compound Edaravone Injection for Acute Ischemic Stroke, a Multi-center, Randomized, Double-blind, Multi-dose, Parallel, and Controlled Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To investigate the efficacy and safety of multi-doses Compound Edaravone Injection versus Edaravone Injection for acute ischemic stroke patients; To provide evidence for the design of Compound Edaravone Injection Phase III trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-dose group
Arm Type
Experimental
Arm Description
Compound Edaravone Injection, 12.5mg/dose (Edaravone 10mg, (+)-Borneol 2.5mg), one dose every 12 hours, continue for 14 days
Arm Title
Medium-dose group
Arm Type
Experimental
Arm Description
Compound Edaravone Injection, 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days
Arm Title
High-dose group
Arm Type
Experimental
Arm Description
Compound Edaravone Injection, 62.5mg/dose (Edaravone 50mg, (+)-Borneol 12.5mg), one dose every 12 hours, continue for 14 days
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Edaravone Injection，30 mg/dose, one dose every 12 hours, continues for 14 days
Intervention Type
Drug
Intervention Name(s)
Compound Edaravone Injection
Intervention Type
Drug
Intervention Name(s)
Edaravone Injection
Primary Outcome Measure Information:
Title
mRS score on day 90
Time Frame
day 90
Title
Change from baseline NIHSS score on day 14
Time Frame
day 14
Secondary Outcome Measure Information:
Title
The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90
Time Frame
day 14, 30, 90
Title
The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90
Time Frame
day 14, 30, 90
Title
The Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90
Time Frame
day 14, 30, 90
Title
Stroke Impact Scale (SIS) score on day 90
Time Frame
day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongjun Wang, MD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Navy General Hospital of The Chinese PLA
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100048
Country
China
Facility Name
Beijing Tiantan Hospital affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
Facility Name
The First Affiliated Hospital of Third Military Medical University of Chinese PLA
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518036
Country
China
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
Hebei General Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Facility Name
The Second Affiliated Hospital of Haerbin Medical University
City
Haerbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
Hunan Provincial People's Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Facility Name
Central Hospital of Baotou
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014040
Country
China
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Facility Name
The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Facility Name
Nanjing Brain Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical College
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221006
Country
China
Facility Name
Jiangxi Provincial People's Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
The General Hospital of Shenyang Military, Chinese PLA
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
The Second Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250033
Country
China
Facility Name
Qingdao Municipal Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266011
Country
China
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China
Facility Name
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
The First Affiliated Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Facility Name
The Second Affiliated Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Facility Name
Tianjin People's Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Tianjin Huanhu Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
31709115
Citation
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.
Results Reference
derived

Learn more about this trial

Compound Edaravone Injection for Acute Ischemic Stroke

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