Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke

Suspended

Phase 2 Results N/A

Update History

28 Jun '16
The eligibility criteria were updated.
New
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
Old
Inclusion Criteria: - Patients must be 35-75years old(hospital patients) ,both male and female; Patients had a clinical diagnosis of acute stroke that had commenced within the six hours before entry into the study; Patients had a score of 6-20 on the National Institutes of Health Stroke Scale and the score ≥2 of item 5 and/or 6; For the first time or always without obvious sequelae of stroke disease(mRS≤1) Exclusion Criteria: - The disease such as Acute intracerebral hemorrhage,tumor and encephalitis ;cause which cause similar symptoms; TIA; Pregnancy and breast-feeding women and male subjects with fertility program
A location was updated in Beijing.
New
The overall status was removed for Beijing Tiantan Hospital affilliated to Capital Medical University.