Compound Edaravone Injection for Acute Ischemic Stroke

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01929096

Collaborator

(none)

400

Enrollment

Locations

Arms

Duration (Months)

14.3

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke	Drug: Compound Edaravone Injection Drug: Edaravone Injection	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low-dose group Compound Edaravone Injection, 12.5mg/dose (Edaravone 10mg, (+)-Borneol 2.5mg), one dose every 12 hours, continue for 14 days	Drug: Compound Edaravone Injection
Experimental: Medium-dose group Compound Edaravone Injection, 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days	Drug: Compound Edaravone Injection
Experimental: High-dose group Compound Edaravone Injection, 62.5mg/dose (Edaravone 50mg, (+)-Borneol 12.5mg), one dose every 12 hours, continue for 14 days	Drug: Compound Edaravone Injection
Active Comparator: Control group Edaravone Injection，30 mg/dose, one dose every 12 hours, continues for 14 days	Drug: Edaravone Injection

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Navy General Hospital of The Chinese PLA	Beijing	Beijing	China	100048
2	Beijing Tiantan Hospital affiliated to Capital Medical University	Beijing	Beijing	China	100050
3	Peking University Third Hospital	Beijing	Beijing	China	100191
4	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing	China	400010
5	The First Affiliated Hospital of Third Military Medical University of Chinese PLA	Chongqing	Chongqing	China	400038
6	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong	China	510080
7	Peking University Shenzhen Hospital	Shenzhen	Guangdong	China	518036
8	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei	China	050000
9	Hebei General Hospital	Shijiazhuang	Hebei	China	050051
10	The Second Affiliated Hospital of Haerbin Medical University	Haerbin	Heilongjiang	China	150001
11	Hunan Provincial People's Hospital	Changsha	Hunan	China	410005
12	Central Hospital of Baotou	Baotou	Inner Mongolia	China	014040
13	Nanjing First Hospital	Nanjing	Jiangsu	China	210006
14	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	China	210011
15	Nanjing Brain Hospital	Nanjing	Jiangsu	China	210029
16	The Affiliated Hospital of Xuzhou Medical College	Xuzhou	Jiangsu	China	221006
17	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi	China	330006
18	The General Hospital of Shenyang Military, Chinese PLA	Shenyang	Liaoning	China	110016
19	Qilu Hospital of Shandong University	Jinan	Shandong	China	250012
20	The Second Hospital of Shandong University	Jinan	Shandong	China	250033
21	Qingdao Municipal Hospital	Qingdao	Shandong	China	266011
22	Shanghai Changzheng Hospital	Shanghai	Shanghai	China	200003
23	Rui Jin Hospital Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai	China	200025
24	The First Affiliated Hospital of Shanxi Medical University	Taiyuan	Shanxi	China	030001
25	The Second Affiliated Hospital of Shanxi Medical University	Taiyuan	Shanxi	China	030001
26	Tianjin People's Hospital	Tianjin	Tianjin	China	300000
27	Tianjin Medical University General Hospital	Tianjin	Tianjin	China	300052
28	Tianjin Huanhu Hospital	Tianjin	Tianjin	China	300060