Efficacy of BNG-1 to Treat Acute Ischemic Stroke (BNG-1)

July 27, 2015 updated by: Tsong-Hai Lee, Chang Gung Memorial Hospital

A Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Compare the Functional Outcome and Safety of Treatment With BNG-1 in Combination With Aspirin With That of Aspirin Alone in Ischemic Stroke Recovery

The objective of this study is to investigate the efficacy and safety of BNG-1 in patients with ischemic stroke. The efficacy assessment will be based on the functional outcome while the safety will be reviewed by the adverse events and laboratory examinations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary endpoint will be performed on the 12 weeks after study drug administered and will compare the favorable rate between treatment with Aspirin alone and combination treatment with BNG-1 and Aspirin in patients with ischemic stroke. The favorable to therapy will be determined if all of the following occurs: alive, Modified Rankin Scale (MRS) < 3, Barthel Index (BI) >= 60.

Secondary objectives are to compare the following:

  1. Compare the favorable rate at one week after study drug administered and the end of treatment (Week 4) and 4 weeks of follow-up (Week 8) of either Aspirin alone or combination treatment with BNG-1 and Aspirin.
  2. Compare the mean change in Barthel Index (BI), at each evaluation time-point of either Aspirin alone or combination treatment with BNG-1 and Aspirin.
  3. Compare the mean change in National Institute of Health Stroke Scale (NIHSS) at each evaluation time-point of either Aspirin alone or combination treatment with BNG-1 and Aspirin.
  4. Compare the Modified Rankin Scale (MRS) at each evaluation time-point of either Aspirin alone or combination treatment with BNG-1 and Aspirin.
  5. Compare the change in Extended Glasgow Outcome Scale (GOS-E) at each evaluation time-point of either Aspirin alone or combination treatment with BNG-1 and Aspirin.

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 3

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

  • Taiwan
    • Taoyuan
      • Kweishan, Taoyuan, Taiwan, 333
        • Stroke center, Department of Neurology, Linkou Chang Gung Memorial Hospital

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Both genders and ages 20 through 65 (subjects are at least 20 years old but not yet 66).
  2. Clinical diagnosis of ischemic stroke, causing a measurable neurological deficit.
  3. Onset of symptoms of ischemic stroke within 10 days of initiation of treatment with the study drug.
  4. Patients have a total National Institutes of Health Stroke Scale (NIHSS) between 8 and 22 inclusive by the time of randomization.
  5. Patients have a total Barth Index (BI) less than 60 or Modified Rankin Scale (MRS) at least 3 by the time of randomization.
  6. No previous history of stroke or previous stroke with Modified Rankin Scale < 1.
  7. Patient must have a CT or MRI examination compatible with the clinical diagnosis of acute ischemic stroke.
  8. Signed informed consent from patient or legally authorized representative.

Exclusion Criteria:

  1. Patient has only major symptoms that are rapidly improving by the time of randomization.
  2. History of stroke within the previous 3 months, exclude TIA.
  3. Patient has a CT or MRI scan with evidence of a non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage.
  4. Patients with known or suspected prior intracranial haemorrhage or history of brain injury or brain tumor.
  5. Patient had documented history of any atrial fibrillation occurring 6 months before randomization.
  6. Hypertension, defined as systolic blood pressure > 185 mmHg or diastolic blood pressure >110 mmHg or requiring aggressive (eg, intravenous antihypertensive) treatment to reduce blood pressure to within these limits.
  7. Recurrent peptic ulcer or gastrointestinal bleeding documented by radiographic or endoscopic means within the past 3 months.
  8. Pregnant or lactating women or women of childbearing potential who are not practicing reliable birth control.
  9. Platelet count less than 100,000 cells/ml.
  10. Activated partial thromboplastin time (aPTT) prolongation greater than 2 seconds above the upper limit of normal for local laboratory.
  11. International normalized ratio (INR) greater than or equal to 1.4.
  12. Uncontrolled hyperglycemia (Sugar AC > 200 mg/dl).
  13. History of alcohol or drug abuse in the previous 3 months.
  14. History of hypersensitivity or intolerance of study drug or aspirin.
  15. Neurological (other than the presenting stroke) or psychiatric conditions that may affect the patient's functional status and/or that may interfere with the patient's assessment.
  16. Previously in the BRAIN-Study or participation in a research protocol for investigation of a pharmaceutical agent or innovative invasive procedure within the past 30 days.
  17. Any other known clinically significant medical disorder (e.g., a severe comorbid disease or dementia, transient cerebral ischemia, lower gastrointestinal bleeding, bleeding diathesis, hepatorenal diseases, cancer, and AIDS).
  18. Patients who have received anticoagulant agents, antiplatelet agents (except Aspirin), thrombolytics with 48-hour before randomization.

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BNG-1 plus Aspirin
BNG-1 3 grams TID plus Aspirin 100mg QD for 4 weeks
Drug: BNG-1
BNG-1 3 grams TID for 4 weeks
Sham Comparator: Aspirin
Aspirin 100mg QD for 4 weeks
Drug: Aspirin
Aspirin 100 mg QD for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Favorable rate
Time Frame: 12 weeks
Favorite rate: A composite of mortality (alive), modified Rankin Scale < 3, AND Barthel Index (BI)>=60
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Favorable rate
Time Frame: 12 weeks
12 weeks
Barthel index
Time Frame: 12 weeks
12 weeks
Modified Rankin Scale
Time Frame: 12 weeks
12 weeks
National Institute of Health Stroke Scale
Time Frame: 12 weeks
12 weeks
Extended Glasgow Outcome Scale
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Tsong-Hai Lee, MD, PhD, Chief of Stroke Center, Linkou Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

April 2, 2012

First Submitted That Met QC Criteria

August 25, 2012

First Posted (Estimate)

August 29, 2012

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BNG-1-PIIIB

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.

Clinical Trials on Ischemic Stroke

Clinical Trials on BNG-1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe