NCT01929096CompletedPhase 2
Compound Edaravone Injection for Acute Ischemic Stroke, a Multi-center, Randomized, Double-blind, Multi-dose, Parallel, and Controlled Phase II Trial
Jiangsu Simcere Pharmaceutical Co., Ltd.28 sites in 1 country400 target enrollmentStarted: August 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 400
- Locations
- 28
- Primary Endpoint
- Change from baseline NIHSS score on day 14
Study Overview
Brief Summary
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
High-dose group
Experimental
Compound Edaravone Injection, 62.5mg/dose (Edaravone 50mg, (+)-Borneol 12.5mg), one dose every 12 hours, continue for 14 days
Intervention: Compound Edaravone Injection (Drug)
Control group
Active Comparator
Edaravone Injection，30 mg/dose, one dose every 12 hours, continues for 14 days
Intervention: Edaravone Injection (Drug)
Low-dose group
Experimental
Compound Edaravone Injection, 12.5mg/dose (Edaravone 10mg, (+)-Borneol 2.5mg), one dose every 12 hours, continue for 14 days
Intervention: Compound Edaravone Injection (Drug)
Medium-dose group
Experimental
Compound Edaravone Injection, 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days
Intervention: Compound Edaravone Injection (Drug)
Outcomes
Primary Outcomes
Change from baseline NIHSS score on day 14
Time Frame: day 14
mRS score on day 90
Time Frame: day 90
Secondary Outcomes
- 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)
- 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 proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90(day 14, 30, 90)
Investigators
Study Sites (28)
Loading locations...
Similar Trials
Completed
Phase 3
Study of Compound Edaravone Injection for Treatment of Acute Ischemic StrokeAcute Ischemic StrokeNCT02430350Jiangsu Simcere Pharmaceutical Co., Ltd.1,200
Completed
Phase 3
Treatment of Acute Ischemic STroke With Edaravone Dexborneol II (TASTE-2)Acute Ischemic StrokeMechanical ThrombectomyEdaravone DexborneolPhase IIINCT05249920Beijing Tiantan Hospital1,362
Unknown
Phase 2
Thrombolysis Combined With Edaravone Dexborneol on Hemorrhagic Transformation for Acute Ischemic StrokeStroke, IschemicNCT05035953Huashan Hospital200
Unknown
Phase 2
Edaravone Dexborneol for Treatment of Acute Ischemic Stroke With Endovascular Therapy in Extended Time WindowsStroke, IschemicNCT04817527First Affiliated Hospital Xi'an Jiaotong University200
Completed
Phase 4
Pilot Study of Edaravone to Treat Acute Myocardial InfarctionReperfusion InjuryMyocardial InfarctionNCT00265239Kumamoto University104