Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02059785
• Other study ID #: CSPC-HA1301
• Status: Suspended
• Phase: Phase 2
• First received: February 7, 2014
• Last updated: June 16, 2016
• Start date: June 2013
• Est. completion date: December 2016

Study information

• Verified date: October 2015
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 216
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Pinocembrin for Injection

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital affilliated to Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determination the proportion of subjects that 0-1 score of mRS after treatment 90 days		90 days	No
Secondary	To compare treatment arms in terms of change from baseline to endpoint in NIHSS score.		90 days	No