Overview

This trial is active, not recruiting.

Condition acute ischemic stroke
Treatments compound edaravone injection, edaravone injection
Phase phase 3
Sponsor Jiangsu Simcere Pharmaceutical Co., Ltd.
Start date May 2015
End date December 2016
Trial size 1200 participants
Trial identifier NCT02430350, SIM-23-02

Summary

The primary objective of the study is to confirm the efficacy of compound Edaravone Injection via intravenous infusion every 12 hours in the patients with Acute Ischemic Stroke(AIS) in a double-blind, active-controlled manner. The study is also to examine the safety of compound Edaravone Injection for the AIS patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Compound Edaravone Injection 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days
compound edaravone injection
(Active Comparator)
Edaravone Injection 30 mg/dose, one dose every 12 hours, continues for 14 days
edaravone injection

Primary Outcomes

Measure
The proportion of patients with mRS ≤1 on day 90
time frame: day 90

Secondary Outcomes

Measure
mRS score on day 90
time frame: day 90
Changes of NIHSS score from baseline on day 14
time frame: day 14
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
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

Eligibility Criteria

Male or female participants from 35 years up to 80 years old.

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 or 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; - Serum Creatinine (SCr) is greater than 1.5×ULN, Creatinine Clearance (CrCl) is less than 50 ml/min or previously known severe renal diseases; - Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase; - Arterial or venous thrombolytic therapy has been applied after onset of stroke; - Patients with malignant tumors or receiving concurrent antitumor treatment; - Patients with severe systemic disease, life expectancy is less than 90 days; - allergic to edaravone , (+)-Borneol or related excipients; - Pregnant or lactating women; - Have major surgery within 4 weeks before enrollment; - Participated in other clinical studies within 30 days before randomization; or participating in other clinical trials at present; - The investigators consider the patients are not suitable for this trial.

Additional Information

Official title Compound Edaravone Injection for Acute Ischemic Stroke, a Multi-center, Randomized, Double-blind, Parallel, and Active-controlled PhaseⅢTrial
Principal investigator Yongjun Wang, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Jiangsu Simcere Pharmaceutical Co., Ltd..