Phase 2 Study of NBP For Patients With Acute Ischemic Stroke "SUNRISE"


Phase 2 Results N/A

Eligibility Criteria

Inclusion Criteria
1. Males or females aged ≥ 18 and ≤ 80 years
2. Women of childbearing potential (WOCBP) must have a negative urine 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 bHCG is the standard of care, then this value can be used to determine eligibility.
3. A clinical diagnosis of mild to moderate cortical or subcortical AIS
4. Able to swallow the softgel capsules as defined by the investigator
5. Completes screening procedures such that study treatment is first administered within 12 hours of stroke onset. The stroke onset time will be defined as the last known normal
6. In subjects receiving tPA, the first dose of NBP must be administered no sooner than 4 hours after the end of the tPA infusion
7. A standard NIHSS score of 4 to 17, inclusive. If patients receive tPA and/or EVT, the NIHSS score must be obtained after the procedure is completed. All subjects must meet a NIHSS consciousness score of 0-1 in order to meet eligibility
8. 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)
9. Capable of understanding the purpose and risk of the study and has signed, in writing, the 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
10. Ability to comply with study requirements
Exclusion Criteria
1. Female subjects who are pregnant, lactating/breast-feeding, or plan to become pregnant within the next 3 months
2. Suspected diagnosis of stroke isolated to brainstem or brain areas other than cortical or subcortical AIS that, in the opinion of the Investigator, may have caused the present symptoms
3. Rapidly improving or resolving symptoms, suggesting a possible transient ischemic attack (TIA) rather than a qualifying stroke
4. Signs of acute hemorrhage or other cause of acute stroke symptoms (other than early ischemic findings) on cranial imaging at Screening
5. History of intracranial hemorrhage
6. Seizure at onset of stroke
7. A previous clinical diagnosis of stroke will exclude the subject (however, the individual with a previously undiagnosed stroke evidenced on screening CT or MRI may be enrolled provided it does not affect neurological and functional assessments based in the opinion of the Investigator)
8. Uncontrolled severe hypertension defined as a systolic BP (SBP) ≥ 220 mm Hg or diastolic BP (DBP) ≥ 110 mm Hg
9. Treatment with intensive antihypertensive therapy, such as intravenous (IV) sodium nitroprusside (Nipride®) and/or more than 30 mg of IV labetalol, between the onset of the AIS and the randomization to study treatment
10. SBP < 100 mm Hg, temperature > 38.0º C, or heart rate < 40 beats/minute or > 120 beats/minute at Screening or prior to randomization
11. A glucose level of < 50 mg/dL at Screening
12. 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
13. A serum ALT or AST level > 1.5 × ULN, or bilirubin > 1.5 ULN (except in setting of known Gilbert's disease) at Screening
14. Clinically significant renal dysfunction (including serum creatinine level > 2.0 mg/dL or 177 µmol/L) at Screening
15. A hemoglobin level < 10 g/dL at Screening
16. 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;
17. Corrected QT > 450 ms for male subjects or > 470 ms for female subjects at Screening or Baseline (average of 3 tracings) ECGs
18. Current diagnosis of cancer or is being treated or has received any treatments for cancer within the last 5 years (except basal cell carcinoma)
19. Known life expectancy < 6 months (for any reason)
20. Known allergy or hypersensitivity to celery or soybeans
21. Received treatment with any other investigational drug within 30 days before Day 1, was previously treated with NBP, or is currently participating in another clinical study
22. 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
23. Known history of hepatitis B, hepatitis C, HIV, or TB
24. Any other reasons in the opinion of the investigator make the subject unsuitable for enrollment