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Compound Edaravone Injection for Acute Ischemic Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01929096
Recruitment Status : Completed
First Posted : August 27, 2013
Last Update Posted : July 3, 2015
Sponsor:
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE August 22, 2013
First Posted Date  ICMJE August 27, 2013
Last Update Posted Date July 3, 2015
Study Start Date  ICMJE August 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2013)
  • mRS score on day 90 [ Time Frame: day 90 ]
  • Change from baseline NIHSS score on day 14 [ Time Frame: day 14 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2013)
  • The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90 [ Time Frame: day 14, 30, 90 ]
  • 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 ]
  • The Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90 [ Time Frame: day 14, 30, 90 ]
  • Stroke Impact Scale (SIS) score on day 90 [ Time Frame: day 90 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compound Edaravone Injection for Acute Ischemic Stroke
Official Title  ICMJE Compound Edaravone Injection for Acute Ischemic Stroke, a Multi-center, Randomized, Double-blind, Multi-dose, Parallel, and Controlled Phase II Trial
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Ischemic Stroke
Intervention  ICMJE
  • Drug: Compound Edaravone Injection
  • Drug: Edaravone Injection
Study Arms  ICMJE
  • Experimental: Low-dose group
    Compound Edaravone Injection, 12.5mg/dose (Edaravone 10mg, (+)-Borneol 2.5mg), one dose every 12 hours, continue for 14 days
    Intervention: 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
    Intervention: 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
    Intervention: Drug: Compound Edaravone Injection
  • Active Comparator: Control group
    Edaravone Injection,30 mg/dose, one dose every 12 hours, continues for 14 days
    Intervention: Drug: Edaravone Injection
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2013)
400
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01929096
Other Study ID Numbers  ICMJE SIM-23-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jiangsu Simcere Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yongjun Wang, MD Beijing Tiantan Hospital
PRS Account Jiangsu Simcere Pharmaceutical Co., Ltd.
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP