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AISPhase 2NCT02905565

NBP in Adult Patients With Acute Ischemic Stroke (AIS)

A Phase 2 study testing NBP Softgel Capsules in people with AIS, run by CSPC-NBP Pharmaceutical Co., Ltd. at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
AIS
What is being tested?
NBP Softgel Capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
177 participants
Where
21 sitesUnited States
Study dates
28 Feb 2018to 7 Aug 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Current or within the last 6 months prior to Screening, New York Heart Association Class III/IV heart failure, severe uncorrected valve disease, known or suspected infective/vegetative endocarditis, ventricular tachycardia, or torsade de pointes.
  • Corrected QTcF (Fridericia) > 450 ms for male subjects or > 470 ms for female subjects (average of 3 ECG tracings) prior to randomization.
  • Current diagnosis of cancer or is being treated or has received any treatments for cancer within the last 5 years except basal cell carcinoma or curatively resected squamous cell carcinoma.
  • Known life expectancy < 6 months (for any reason).
  • Known allergy or hypersensitivity to celery or soybeans.
  • Received treatment with any other investigational drug within 30 days before Baseline, was previously treated with NBP, is currently taking celery seed extract, or is currently participating in another clinical study.
  • Known or suspected history of alcohol or drug dependence within the past 6 months, or is known to have abused alcohol (eg, been intoxicated) within the last 24 hours.
  • Known history of hepatitis B, hepatitis C, HIV, or tuberculous (TB).
  • Any other reasons that, in the opinion of the investigator, make the subject unsuitable for enrollment.

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

United States21 sites

  • Investigative Site

    Asheville, North Carolina, 28801

  • Investigative Site

    Boston, Massachusetts, 02111

  • Investigative Site

    Buffalo, New York, 14202

  • Investigative Site

    Burlington, Vermont, 05401

  • Investigative Site

    Charleston, South Carolina, 29425

  • Investigative Site

    Chattanooga, Tennessee, 37403

  • Investigative Site

    Columbia, South Carolina, 29203

  • Investigative Site

    Columbus, Ohio, 43210

  • Investigative Site

    Des Moines, Iowa, 50314

  • Investigative Site

    Golden Valley, Minnesota, 55422

  • Investigative Site

    Hillsboro, Oregon, 97123

  • Investigative Site

    Jacksonville, Florida, 32209

  • Investigative Site

    Los Angeles, California, 90027

  • Investigative Site

    Los Angeles, California, 90095

  • Investigative Site

    Louisville, Kentucky, 40202

  • Investigative Site

    Omaha, Nebraska, 68123

  • Investigative Site

    Philadelphia, Pennsylvania, 19104

  • Investigative Site

    Portland, Oregon, 97213

  • Investigative Site

    Portland, Oregon, 97225

  • Investigative Site

    Portland, Oregon, 97239

  • Investigative Site

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Add-On to Standard Of-Care Study of n Butylphthalide (NBP) Softgel Capsules for Treatment of Mild to Moderate Acute Ischemic Stroke (AIS) in Adult Subjects

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.

Read the detailed description

This is a randomized, double-blind, placebo-controlled, add-on to standard-of-care study with a primary objective to assess the safety of NBP treatment in patients with mild to moderate acute ischemic stroke. The secondary objectives include determination of pharmacokinetic (PK) profile and exploratory evaluation for the efficacy of NBP treatment in stroke patients.

All randomized subjects will also receive standard supportive medical care for treatment of AIS throughout the study. The overall duration of the study will be approximately 90 days, including 30 days of treatment and an additional 60 days for follow up assessments. Subjects will be hospitalized long enough to receive the first four doses of study drug. After discharge from the hospital, subjects will continue to take study treatment daily through Day 30 and have scheduled assessments completed.

To maintain the blind, all subjects will take 4 softgel capsules BID, which will contain either 100 mg NBP or matching placebo. The first dose must be taken within 12 hours of the onset of the AIS defined as the last known normal.

Conditions
AIS
Being tested
NBP Softgel Capsules, Placebo
Keywords
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Add-On to Standard-of-Care, Safety, Efficacy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NBP Softgel CapsulesDrug

    Also called NBP

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

  • PlaceboDrug

    Also called NBP Placebo Softgel Capsules

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

Study groups in NCT02905565
Study groupRoleWhat they receive
PlaceboPlacebo comparatorInterventions: Placebo (NBP placebo softgel capsules, 0 mg NBP, BID)
Receives: Drug: Placebo
800 mg of NBP dailyActive comparatorInterventions: 800 mg NBP softgel capsules daily (400 mg BID)
Receives: Drug: NBP Softgel Capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 90 days

Secondary outcomes (5)

  1. PK profile of NBP treatment in subjects with AIS

    Peak and trough levels of NBP and metabolites

    Measured: 1 day

  2. Exploratory efficacy outcome: mRS

    Improvement of disability as measured by the mRS at Day 30 and Day 90

    Measured: 90 days

  3. Exploratory efficacy outcome: Barthel Index (BI) Assessment

    Stroke recovery as measured by the BI Assessment at Day 30 and Day 90

    Measured: 90 days

  4. Exploratory efficacy outcome: NIHSS

    Stroke recovery as measured by the NIHSS at Day 30 and Day 90

    Measured: 90 days

  5. Exploratory efficacy outcome: Stroke Impact Scale (SIS) Assessment

    SIS-16 on study Day 30 and 90

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2016 (estimated)
  2. Study start28 Feb 2018
  3. Primary completion7 Aug 2020
  4. Study completion7 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
177 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02905565
Sponsor's protocol ID
CSPC-NBP-2001
Status last verified
Nov 2019
First submitted
23 Aug 2016
Last updated
17 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NBP Softgel Capsules in people with AIS, run by CSPC-NBP Pharmaceutical Co., Ltd. at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate of treatment-emergent adverse events (TEAEs) (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02905565.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2020.

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