Acute Ischemic Stroke
Conditions
Interventions
investigational material(s)
Generic name etc : JTR-161
INN of investigational material : -
Therapeutic category code : 49- Other agents affecting cellular function
Dosage and Administration for Invest
Sponsors
Teijin Pharma Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main Inclusion Criteria -Patients who have ischemic strokes in the anterior circulation -Patients whose mRS is 0 or 1 prior to the onset of ischemic stroke -Patients whose NIHSS score of >=5 to <=20 at screening -Patients who can be administered dosing solutions within 48 h of stroke onset
Exclusion criteria
Exclusion criteria: Main Exclusion Criteria -Patients who have new ischemic lesion in the cerebellum or brainstem -Patients whose consciousness level drops severely -Patients whose infarct area is widespread -Patients who have a clinically significant hemorrhagic transformation -Patients who had seizures after onset of ischemic stroke -Patients who have medical history of a neurological event such as stroke or clinically significant head trauma within 180 days prior to giving informed consent -Patients who have poor blood pressure control -Patients who have poor glycaemic control -Patients who have the following complications -Severe liver dysfunction -Severe kidney dysfunction -Severe heart failure -Severe pulmonary dysfunction -Severe infections -Patients who have any neurological disorder affecting informed consent or study assessments -Patients who have the malignant tumor, or medical history of malignant tumor within 2 years prior to the onset of ischemic stroke -Patients who have a contraindication for MRI -Patients who have thrombocytopenia -Patients who have medical history of allergy to products derived from human tissues, bovine or porcine -Patients who have medical history of allergy to streptomycin -Patients who have undergone splenectomy in the past -Patients who have a possibility of transient ischemic attack -Patients who are scheduled to undergo revascularization (carotid endarterectomy, stent placement etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy The percentage of patients who achieved Excellent outcome (modified Rankin Scale [mRS] =95) on Day 91 in Cohort 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy exploratory Main Outcome Efficacy -EQ-5D-5L Safety -adverse events -lab tests -vital signs -oxygen saturation -MRI Exploration -biomarkers -MRI | — |
Countries
Japan
Outcome results
None listed