NCT Number: NCT01929096
Compound Edaravone Injection for Acute Ischemic Stroke
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.
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Conditions
Age range
35 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Beijing Tiantan Hospital affiliated to Capital Medical University, Beijing, Beijing Municipality, China
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Edaravone Injection
DrugPrimary outcomes
-
mRS score on day 90
Time frame: day 90
-
Change from baseline NIHSS score on day 14
Time frame: day 14
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Industry
Registry information
Official study title
Compound Edaravone Injection for Acute Ischemic Stroke, a Multi-center, Randomized, Double-blind, Multi-dose, Parallel, and Controlled Phase II Trial
Important dates
- Study start
- 2013
- Primary completion
- 2014
- Study completion
- 2015
- First posted
- Aug 27, 2013
- Registry last updated
- Jul 3, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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