NBP in Adult Patients With Acute Ischemic Stroke (AIS)

NCT02905565 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: CSPC-NBP-2001
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 21

Brief Summary

This is a Phase 2 multicenter, randomized, double-blind, placebo-controlled, add-on to standard of care study of NBP softgel capsules for the treatment of mild to moderate AIS in adults.

Conditions

AIS

Keywords

Multicenter; Randomized; Double-Blind; Placebo-Controlled; Add-On to Standard-of-Care; Safety; Efficacy

Outcome Measures

Primary Outcomes (1)

• Incidence rate of treatment-emergent adverse events (TEAEs)

  Safety will be evaluated through the collection of TEAEs, serious adverse events (SAEs), clinical laboratory assessments, vital sign measurements, 12-lead ECGs, and physical and neurologic examinations. Suicidality will be evaluated at each clinical visit using the Columbia-Suicide Severity Rating Scale (C-SSRS).

  90 days

Secondary Outcomes (5)

• PK profile of NBP treatment in subjects with AIS

  1 day

• Exploratory efficacy outcome: mRS

  90 days

• Exploratory efficacy outcome: Barthel Index (BI) Assessment

  90 days

• Exploratory efficacy outcome: NIHSS

  90 days

• Exploratory efficacy outcome: Stroke Impact Scale (SIS) Assessment

  90 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Interventions: Placebo (NBP placebo softgel capsules, 0 mg NBP, BID)

Drug: Placebo

800 mg of NBP daily

ACTIVE COMPARATOR

Interventions: 800 mg NBP softgel capsules daily (400 mg BID)

Drug: NBP Softgel Capsules

Interventions

NBP Softgel Capsules DRUG

Take 4 capsules BID on an empty stomach at least 1 hour before food intake, and remain fasting at least 1 hour after dosing.

Also known as: NBP

800 mg of NBP daily

Placebo DRUG

Take 4 capsules BID on an empty stomach at least 1 hour before food intake, and remain fasting at least 1 hour after dosing

Also known as: NBP Placebo Softgel Capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged ≥ 18 and ≤ 85 years.
• Women of childbearing potential (WOCBP) must have a negative urine human chorionic gonadotropin (HCG) pregnancy test at Screening and be practicing a medically acceptable method of contraception with an annual failure rate of less than 1% until the completion of the trial or 60 days after discontinuation of study treatment. Women are considered not childbearing if they are \> 1 year postmenopausal or surgically sterile (ie, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy tubal ligation). If serum beta human chorionic gonadotropin (bHCG) is the standard of care, then this value can be used to determine eligibility.
• A clinical diagnosis of mild to moderate cortical or subcortical AIS.
• Able to swallow the softgel capsules as defined by the investigator.
• Completes screening procedures such that study treatment is first administered within 24 hours of stroke onset. The stroke onset time will be defined as the last known normal.
• If Tissue Plasminogen Activator (tPA) is given as part of standard of care, the first dose of NBP must be administered no sooner than 4 hours after the end of the tPA infusion.
• A standard NIHSS score of 4 to 17, inclusive. If patients receive tPA and/or endovascular treatment (EVT), the NIHSS score must be obtained after the infusion and/or procedure is completed. If sedation is used for EVT, then the NIHSS score must be obtained after sedation no longer confounds the assessment. All subjects must meet a NIHSS consciousness score of 0-1 in order to meet eligibility.
• Functionally independent, as defined by a Modified Rankin Scale (mRS) score of 0 to 1 before their present illness as determined by the subject or provided by a representative if the subject is unable to participate at the time of study entry (determined by retrospective assessment by the Investigator).
• Capable of understanding the purpose and risk of the study and has signed, in writing, the Informed Consent Form (ICF). If the subject is not capable of this at the time of enrollment, a legally authorized representative (LAR) will provide written informed consent in accordance with all regulations.
• Ability to comply with study requirements.

You may not qualify if:

• Female subjects who are pregnant, lactating/breast-feeding, or plan to become pregnant within the next 3 months.
• Suspected diagnosis of stroke isolated to brainstem or brain areas other than cortical or subcortical AIS that may have caused the present symptoms, based on the opinion of the Investigator.
• Rapidly improving or resolving symptoms, suggesting a possible transient ischemic attack (TIA) rather than a qualifying stroke.
• Signs of acute intracranial hemorrhage or symptomatic hemorrhagic transformation of AIS defined by a 4-point worsening in NIHSS from presentation, or other cause of acute stroke symptoms (other than early ischemic findings) on cranial imaging at Screening.
• History of intracranial hemorrhage.
• Seizure at onset of stroke.
• A previous clinical diagnosis of stroke within 6 months of current AIS. A previously undiagnosed stroke evidenced on screening CT or MRI may be enrolled provided it does not affect neurological and functional assessments based on the opinion of the Investigator.
• Uncontrolled severe hypertension defined as a systolic blood pressure (SBP) ≥ 220 mm Hg or diastolic blood pressure (DBP) ≥ 110 mm Hg.
• Treatment with intensive antihypertensive therapy within 4 hours of randomization.
• SBP \< 100 mm Hg, temperature \> 38.0º C, or heart rate \< 40 beats/minute or \> 120 beats/minute at Screening or prior to randomization.
• A glucose level of \< 50 mg/dL at Screening.
• An international normalized ratio (INR) ≥ 1.5 if not being treated with anticoagulant therapy, or an INR ≥ 3.5 if being treated with an acceptable anticoagulant therapy.
• A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level \> 1.5 × Upper Limits of Normal (ULN), or bilirubin \> 1.5 ULN (except in setting of known Gilbert's disease) at Screening.
• Clinically significant renal dysfunction (including serum creatinine level \> 2.0 mg/dL or 177 µmol/L) at Screening.
• A hemoglobin level \< 10 g/dL at Screening.

Sponsors & Collaborators

• CSPC-NBP Pharmaceutical Co., Ltd.: lead

Study Sites (21)

Investigative Site

Los Angeles, California, 90027, United States

Location

Investigative Site

Los Angeles, California, 90095, United States

Location

Investigative Site

Jacksonville, Florida, 32209, United States

Location

Investigative Site

Des Moines, Iowa, 50314, United States

Location

Investigative Site

Louisville, Kentucky, 40202, United States

Location

Investigative Site

Boston, Massachusetts, 02111, United States

Location

Investigative Site

Golden Valley, Minnesota, 55422, United States

Location

Investigative Site

St Louis, Missouri, 63110, United States

Location

Investigative Site

Omaha, Nebraska, 68123, United States

Location

Investigative Site

Buffalo, New York, 14202, United States

Location

Investigative Site

Asheville, North Carolina, 28801, United States

Location

Investigative Site

Columbus, Ohio, 43210, United States

Location

Investigative Site

Hillsboro, Oregon, 97123, United States

Location

Investigative Site

Portland, Oregon, 97213, United States

Location

Investigative Site

Portland, Oregon, 97225, United States

Location

Investigative Site

Portland, Oregon, 97239, United States

Location

Investigative Site

Philadelphia, Pennsylvania, 19104, United States

Location

Investigative Site

Charleston, South Carolina, 29425, United States

Location

Investigative Site

Columbia, South Carolina, 29203, United States

Location

Investigative Site

Chattanooga, Tennessee, 37403, United States

Location

Investigative Site

Burlington, Vermont, 05401, United States

Location

Study Officials

• Wayne Clarke, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: September 19, 2016
• Study Start: February 28, 2018
• Primary Completion: August 7, 2020
• Study Completion: August 7, 2020
• Last Updated: September 17, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)