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Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke

Primary Purpose

Ischemic Stroke

Status
Suspended
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pinocembrin for Injection
Sponsored by
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Pinocembrin for Injection, Placebo, mRS

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Tiantan Hospital affilliated to Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pinocembrin for Injection

placebo

Arm Description

40mg /60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day

60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To compare treatment arms in terms of change from baseline to endpoint in NIHSS score.

Full Information

First Posted
February 7, 2014
Last Updated
June 16, 2016
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02059785
Brief Title
Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke
Official Title
Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke---Randomized, Double-blind, Placebo-controlled, Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Suspended
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Pinocembrin for Injection, Placebo, mRS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pinocembrin for Injection
Arm Type
Experimental
Arm Description
40mg /60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day
Intervention Type
Drug
Intervention Name(s)
Pinocembrin for Injection
Other Intervention Name(s)
DL0108
Primary Outcome Measure Information:
Title
To determination the proportion of subjects that 0-1 score of mRS after treatment 90 days
Time Frame
90 days
Secondary Outcome Measure Information:
Title
To compare treatment arms in terms of change from baseline to endpoint in NIHSS score.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Yong Jun, Ph.D
Organizational Affiliation
Beijing Tiantan Hospital affilliated to Capital Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Tiantan Hospital affilliated to Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China

12. IPD Sharing Statement

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Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke

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