Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke

Phase 2

Suspended

• Conditions: Ischemic Stroke
• Interventions: Drug: Pinocembrin for Injection

• Registration Number: NCT02059785
• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-02-07
• Study First Submitted QC: 2014-02-07
• Study First Posted: 2014-02-11
• Status Verified: 2015-10
• Last Update Submitted: 2016-06-16
• Last Update Posted: 2016-06-20
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pinocembrin for Injection	Pinocembrin for Injection	40mg /60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day
placebo	Pinocembrin for Injection	60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day

Primary Outcome Measures

Name	Time	Method
To determination the proportion of subjects that 0-1 score of mRS after treatment 90 days	90 days

Secondary Outcome Measures

Name	Time	Method
To compare treatment arms in terms of change from baseline to endpoint in NIHSS score.	90 days

Trial Locations

Locations (1)

Beijing Tiantan Hospital affilliated to Capital Medical University; 🇨🇳 Beijing, Beijing, China