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Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT02059785
Recruitment Status : Suspended
First Posted : February 11, 2014
Last Update Posted : June 20, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: Pinocembrin for Injection Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke---Randomized, Double-blind, Placebo-controlled, Multicenter Study
Study Start Date : June 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Pinocembrin for Injection
40mg /60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day
Drug: Pinocembrin for Injection
Other Name: DL0108

Placebo Comparator: placebo
60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day
Drug: Pinocembrin for Injection
Other Name: DL0108




Primary Outcome Measures :
  1. To determination the proportion of subjects that 0-1 score of mRS after treatment 90 days [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. To compare treatment arms in terms of change from baseline to endpoint in NIHSS score. [ Time Frame: 90 days ]


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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059785


Locations
China, Beijing
Beijing Tiantan Hospital affilliated to Capital Medical University
Beijing, Beijing, China, 100050
Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
Study Director: Wang Yong Jun, Ph.D Beijing Tiantan Hospital affilliated to Capital Medical University

Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT02059785     History of Changes
Other Study ID Numbers: CSPC-HA1301
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: October 2015

Keywords provided by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.:
Pinocembrin for Injection
Placebo
mRS

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia