Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke

November 14, 2019 updated by: Jeil Pharmaceutical Co., Ltd.

A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke

Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Recruiting
        • Inje University Busan Paik Hospital
        • Contact:
          • Eung-Gyu Kim, MD., PhD
      • Busan, Korea, Republic of
        • Recruiting
        • Dong-A University Hospital
        • Contact:
      • Changwon, Korea, Republic of
        • Recruiting
        • Gyeongsang National University Changwon Hospital
        • Contact:
          • Seunguk Jung, MD
      • Daegu, Korea, Republic of
        • Recruiting
        • Yeungnam University Medical Center
        • Contact:
      • Gwangju, Korea, Republic of
        • Recruiting
        • Chonnam National University Hospital
        • Contact:
      • Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
      • Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Inje University Ilsan Paik Hospital
        • Contact:
      • Incheon, Korea, Republic of
        • Recruiting
        • Catholic Kwandong University International St. Mary's Hospital
        • Contact:
          • Sang Joon An, MD
      • Jeju, Korea, Republic of
        • Recruiting
        • Jeju National University Hospital
        • Contact:
      • Jinju, Korea, Republic of
        • Recruiting
        • Gyeongsang National University Hospital
        • Contact:
      • Pusan, Korea, Republic of
        • Recruiting
        • Pusan National University Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Hanyang University Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Ewha Womans University Seoul Hospital
        • Contact:
          • Tae Jin Song, MD., PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with acute ischemic stroke, aging ≥ 19
  • Confirmed to have acute anterior circulation cerebral artery occlusion in intracranial internal carotid artery (IICA) or middle cerebral artery (MCA) M1 segment by CT or MR angiography.
  • National Institutes of Health Stroke Scale(NIHSS) is 6~30 before endovascular recanalization therapy (ERT)
  • Subject who is reperfused with 2b or 3 stages of thrombolysis in cerebral infarction (TICI) (However, if angiography is conducted for thrombectomy after IV tPA treatment and the effect of tPA results in TICI 2b-3 reperfusion, the subject can participate)
  • Subject who can administer IP within 6.5 hrs of symptom development
  • Subject who can administer IP within 30 min of vascular reperfusion
  • Subject who can evaluate MRI within 90 min of vascular reperfusion

Exclusion Criteria:

  • Subject who is contraindicated for endovascular recanalization
  • Subject who has hypersensitivity to contrast agent or component of investigational product
  • Prohibited or unable to perform MRI test
  • Medical history that is related to bleeding
  • History of hemorrhagic stroke within 6 months of study participation
  • Subjects with chronic liver disorder
  • Kidney disorder (Serum creatinine > 3 mg/dL)
  • Life expectancy is less than 3 months due to concomitant disease other than stroke
  • Pregnant or lactating women
  • Those who have taken tirofiban (anticoagulant agent) during endovascular recanalization therapy
  • Those who have taken other investigational drugs and/or medical instruments 12 weeks prior to screening
  • Subject is unable to be followed up
  • Subject is deemed unable to participate the study in the opinion of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-dose group
JPI-289 Low dose or placebo
Drug: JPI-289 Low-dose
JPI-289 Low dose will be intravenously administered during 24 hours
Experimental: High-dose group
JPI-289 High dose or placebo
Drug: JPI-289 High-dose
JPI-289 High dose will be intravenously administered during 24 hours
Placebo Comparator: Placebo group
Same dosage of JPI-289 low and high dose
Drug: Placebo
Same dosage of JPI-289 Low and Hogh dose will be intravenously administered during 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infact growth ratio from baseline
Time Frame: 4 days from baseline
4 days from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeil Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

February 20, 2017

First Submitted That Met QC Criteria

February 20, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 14, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JPI-289-P2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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