ClinicalTrials.gg
Sign In
SuspendedNCT02059785Updated Jun 20, 2016

Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke

A Phase 2 interventional study of Pinocembrin for Injection in Ischemic Stroke, sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.. Suspended at 1 site in China. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-06-20.

Sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (part of CSPC Pharmaceutical Group Limited) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
216
Allocation
Randomized
Ages
35 Years to 75 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Ischemic Stroke

Browse trials for

Keywords

  • Pinocembrin for Injection
  • Placebo
  • mRS
03

In context

Ischemic Stroke

2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.

This study's planned enrollment of 216 is above the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd. is the lead sponsor of 166 studies on the registry; 47 are open to participants now.

Browse CSPC ZhongQi Pharmaceutical Technology Co., Ltd. studies →All CSPC Pharmaceutical Group Limited studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
216 participants (estimated)

Study arms

  • Experimental
    Pinocembrin for Injection

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

    Drug: Pinocembrin for Injection

  • Placebo comparator
    placebo

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

    Drug: Pinocembrin for Injection

Interventions

  • DrugPinocembrin for Injection

    Also known as: DL0108

06

What researchers measure

Primary outcomes

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

    Time frame: 90 days

Secondary outcomes

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

    Time frame: 90 days

07

Study locations

1 site
  • Beijing Tiantan Hospital affilliated to Capital Medical University
    Beijing, Beijing Municipality 100050, China
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2013, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 7, 2014
First posted
Feb 11, 2014
Start
Jun 2013
Primary completionEst.
Dec 2016
CompletionEst.
Dec 2016
Last update
Jun 20, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02059785
Lead sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Responsible party
Sponsor
First posted
Feb 11, 2014
Start date
Jun 2013
Primary completion
Dec 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Jun 20, 2016

Study contacts

Wang Yong Jun, Ph.D
study director · Beijing Tiantan Hospital affilliated to Capital Medical University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Ischemic Stroke →

Other studies from this sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd. →

Start the discussion