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.
The primary endpoint will be performed on the 12 weeks after study drug administered and will compare the favorable rate between treatment with Aspirin alone and combination treatment with BNG-1 and Aspirin in patients with ischemic stroke. The favorable to therapy will be determined if all of the following occurs: alive, Modified Rankin Scale (MRS) \< 3, Barthel Index (BI) \>= 60. Secondary objectives are to compare the following: 1. Compare the favorable rate at one week after study drug administered and the end of treatment (Week 4) and 4 weeks of follow-up (Week 8) of either Aspirin alone or combination treatment with BNG-1 and Aspirin. 2. Compare the mean change in Barthel Index (BI), at each evaluation time-point of either Aspirin alone or combination treatment with BNG-1 and Aspirin. 3. Compare the mean change in National Institute of Health Stroke Scale (NIHSS) at each evaluation time-point of either Aspirin alone or combination treatment with BNG-1 and Aspirin. 4. Compare the Modified Rankin Scale (MRS) at each evaluation time-point of either Aspirin alone or combination treatment with BNG-1 and Aspirin. 5. Compare the change in Extended Glasgow Outcome Scale (GOS-E) at each evaluation time-point of either Aspirin alone or combination treatment with BNG-1 and Aspirin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
129
Stroke center, Department of Neurology, Linkou Chang Gung Memorial Hospital
Kweishan, Taoyuan, Taiwan
Favorable rate
Favorite rate: A composite of mortality (alive), modified Rankin Scale \< 3, AND Barthel Index (BI)\>=60
Time frame: 12 weeks
Favorable rate
Time frame: 12 weeks
Barthel index
Time frame: 12 weeks
Modified Rankin Scale
Time frame: 12 weeks
National Institute of Health Stroke Scale
Time frame: 12 weeks
Extended Glasgow Outcome Scale
Time frame: 12 weeks
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