Compound Edaravone Injection for Acute Ischemic Stroke

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Drug: Compound Edaravone Injection
* Drug: Edaravone Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mRS score on day 90 |  | day 90 | 
| Change from baseline NIHSS score on day 14 |  | day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |