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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Drug: Compound Edaravone Injection Drug: Edaravone Injection Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : August 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke
Drug Information available for: Edaravone

Arms and Interventions
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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
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Primary Outcome Measures :
  1. mRS score on day 90 [ Time Frame: day 90 ]
  2. Change from baseline NIHSS score on day 14 [ Time Frame: day 14 ]

Secondary Outcome Measures :
  1. The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90 [ Time Frame: day 14, 30, 90 ]
  2. 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 ]
  3. The Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90 [ Time Frame: day 14, 30, 90 ]
  4. Stroke Impact Scale (SIS) score on day 90 [ Time Frame: day 90 ]

Eligibility Criteria
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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929096


Locations
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Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Yongjun Wang, MD Beijing Tiantan Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01929096    
Other Study ID Numbers: SIM-23-01
First Posted: August 27, 2013    Key Record Dates
Last Update Posted: July 3, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
 Brain Infarction
Brain Ischemia
Infarction
Necrosis
Edaravone
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs