Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke

• Status: Suspended
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Criteria

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