Compound Edaravone Injection for Acute Ischemic Stroke

Simcere

Status and phase: Completed; Phase 2

Conditions: Acute Ischemic Stroke

Treatments: Drug: Compound Edaravone Injection; Drug: Edaravone Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT01929096

SIM-23-01

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 4 patient groups

Low-dose group

Experimental group

Description:

Compound Edaravone Injection, 12.5mg/dose (Edaravone 10mg, (+)-Borneol 2.5mg), one dose every 12 hours, continue for 14 days

Treatment:

Drug: Compound Edaravone Injection

Medium-dose group

Experimental group

Description:

Compound Edaravone Injection, 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days

Treatment:

Drug: Compound Edaravone Injection

High-dose group

Experimental group

Description:

Compound Edaravone Injection, 62.5mg/dose (Edaravone 50mg, (+)-Borneol 12.5mg), one dose every 12 hours, continue for 14 days

Treatment:

Drug: Compound Edaravone Injection

Control group

Active Comparator group

Description:

Edaravone Injection，30 mg/dose, one dose every 12 hours, continues for 14 days

Treatment:

Drug: Edaravone Injection