Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke

Study Overview
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Brief Summary
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This research is a Randomized, double-blind, placebo-controlled, multicenter clinical study. Chinese subjects with Ischemic Stroke.

Detailed Description
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Subjects will randomly enter into one of two groups,the period of treatment is 14 days,follow-up to the 90th days.

Official Title
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Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke---Randomized, Double-blind, Placebo-controlled, Multicenter Study

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: Pinocembrin for Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 35-75 hospitalized patients Patients with acute stroke ≤24h NIHSS score 6-20 at time of enrollment , the score ≥2 of item 5 and/or 6 For the first time or always without obvious sequelae of stroke disease(mRS≤1） Informed consent Exclusion Criteria: The disease such as Acute intracerebral hemorrhage,tumor and encephalitis which cause similar symptoms Patient with NIHSS level of consciousness score≥2 or dementia,or other patients who the investigator think that don't fit into the study TIA Symptoms of disease rapidly improving during the randomized Severe hypertension(SBP > 200 mmHg or DBP >110 mmHg) Inadequate liver function(AST or ALT greater than 2 times the upper limit of normal values);Renal impairment (Creatinine clearance <60ml/min） Severe system or viscera organic disease Have used other neuroprotectant or other experimental drugs Patient who are unlikely to complete the study that due to a severe clinical condition Pregnant or breast-feeding Participation in a previous clinical study within 30 days Meets all other exclusion criteria

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pinocembrin for Injection<br>40mg /60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day | Drug: Pinocembrin for Injection<br> <br> * Other names: DL0108;|
| Placebo Comparator: placebo<br>60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day | Drug: Pinocembrin for Injection<br> <br> * Other names: DL0108;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determination the proportion of subjects that 0-1 score of mRS after treatment 90 days |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare treatment arms in terms of change from baseline to endpoint in NIHSS score. |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pinocembrin for Injection, Placebo, mRS