Efficacy of BNG-1 to Treat Acute Ischemic Stroke

NCT01675115 | Completed Phase 3 DMC

• 1 other identifier: BNG-1-PIIIB
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Stroke

Keywords

Ischemic stroke; Traditional Chinese Medication; Aspirin

Outcome Measures

Primary Outcomes (1)

• Favorable rate

  Favorite rate: A composite of mortality (alive), modified Rankin Scale \< 3, AND Barthel Index (BI)\>=60

  12 weeks

Secondary Outcomes (5)

• Favorable rate

  12 weeks

• Barthel index

  12 weeks

• Modified Rankin Scale

  12 weeks

• National Institute of Health Stroke Scale

  12 weeks

• Extended Glasgow Outcome Scale

  12 weeks

Study Arms (2)

BNG-1 plus Aspirin

ACTIVE COMPARATOR

BNG-1 3 grams TID plus Aspirin 100mg QD for 4 weeks

Drug: BNG-1

Aspirin

SHAM COMPARATOR

Aspirin 100mg QD for 4 weeks

Drug: Aspirin

Interventions

BNG-1 DRUG

BNG-1 3 grams TID for 4 weeks

BNG-1 plus Aspirin

Aspirin DRUG

Aspirin 100 mg QD for 4 weeks

Aspirin

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patient has only major symptoms that are rapidly improving by the time of randomization.
• History of stroke within the previous 3 months, exclude TIA.
• Patient has a CT or MRI scan with evidence of a non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage.
• Patients with known or suspected prior intracranial haemorrhage or history of brain injury or brain tumor.
• Patient had documented history of any atrial fibrillation occurring 6 months before randomization.
• 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.
• Recurrent peptic ulcer or gastrointestinal bleeding documented by radiographic or endoscopic means within the past 3 months.
• Pregnant or lactating women or women of childbearing potential who are not practicing reliable birth control.
• Platelet count less than 100,000 cells/ml.
• Activated partial thromboplastin time (aPTT) prolongation greater than 2 seconds above the upper limit of normal for local laboratory.
• International normalized ratio (INR) greater than or equal to 1.4.
• Uncontrolled hyperglycemia (Sugar AC \> 200 mg/dl).
• History of alcohol or drug abuse in the previous 3 months.
• History of hypersensitivity or intolerance of study drug or aspirin.
• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Stroke center, Department of Neurology, Linkou Chang Gung Memorial Hospital

Kweishan, Taoyuan, 333, Taiwan

Location

Related Publications (1)

• Hsieh CY, Lin HJ. Letter by Hsieh and Lin Regarding Article, "Acute Reperfusion Therapy and Stroke Care in Asia After Successful Endovascular Trials". Stroke. 2015 Aug;46(8):e198. doi: 10.1161/STROKEAHA.115.010253. Epub 2015 Jul 2. No abstract available.

  PMID: 26138124 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Tsong-Hai Lee, MD, PhD

  Chief of Stroke Center, Linkou Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Stroke Center

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: August 29, 2012
• Study Start: August 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

TW (1)