n-Butylphthalide (NBP) Softgel Capsules in Stroke Patients

Not yet recruiting

Phase 2 Results N/A

Eligibility Criteria

Inclusion Criteria
Subjects are eligible to be included in the study only if all of the following criteria apply:
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). Examples of approved contraception are oral progestogen, oral combined contraceptives with estrogen and progesterone, Depo injections, transdermally delivered contraceptives, IUD, vaginal ring, diaphragm with spermicide or condom, and condom with spermicide; bilateral tubal ligation. Vasectomy of a male partner along with a second method of approved contraception or abstinence as long as the subject agrees not to engage in sexual activity throughout the duration of trial
3. A clinical diagnosis of mild to moderate cortical or subcortical AIS
4. Able to swallow the softgel capsules as assessed by a swallowing evaluation
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 time when the individual did not experience current acute stroke symptoms
6. A standard NIHSS score of 6 to 20 and/or an age-adjusted NIHSS score of 19 to 30, inclusive (calculated as [age in years/5] + standard NIHSS score)
7. Fully conscious during the screening process (slight drowsiness is acceptable) corresponding to a Level of Consciousness score on the NIHSS assessment of 0 to 1
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 and has signed, in writing, the ICF; if the subject is not capable of this at the time of enrollment, an authorized representative must provide written informed consent and the subject will provide it when capable
10. Agrees to comply with protocol requirements
Exclusion Criteria
Subjects are excluded from the study if any of the following criteria apply:
1. Female subjects who are pregnant, lactating/breast-feeding, or plan to become pregnant within the next 3 months
2. Suspected diagnosis 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 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. Treated (or is expected to be treated) during this hospitalization with medications for cerebral edema due to stroke (eg, glycerol or mannitol)
8. 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)
9. Treated or plan to be treated with tPA (or other acute thrombolytics) or endovascular therapy; however, anticoagulants used at approved doses are permissible
10. Uncontrolled severe hypertension defined as a systolic BP (SBP) ≥ 220 mm Hg or diastolic BP (DBP) ≥ 110 mm Hg
11. 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
12. SBP < 100 mm Hg, temperature > 38.0º C, or heart rate < 40 beats/minute or > 120 beats/minute at Screening or prior to randomization
13. A glucose level of < 50 mg/dL at Screening
14. 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
15. A serum ALT or AST level > 1.5 × ULN, or bilirubin > 1.5 ULN (except in setting of known Gilbert's disease) at Screening
16. Clinically significant renal dysfunction (including serum creatinine level > 2.0 mg/dL or 177 μmol/L) at Screening
17. A hemoglobin level < 11 g/dL at Screening
18. 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;
19. Corrected QT > 450 ms for male subjects or > 470 ms for female subjects at Screening or Baseline (average of 3 tracings) ECGs
20. Current diagnosis of cancer or is being treated or has received any treatments for cancer within the last 5 years (except basal cell carcinoma)
21. Known life expectancy < 6 months (for any reason)
22. Known allergy or hypersensitivity to celery or soybeans
23. 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
24. History of alcohol or drug dependence, or is known to have abused alcohol (eg, been intoxicated) within the last 24 hours or confirmed drug abuse at Screening
25. History of hepatitis B, hepatitis C, HIV, or TB