A Phase 2 interventional study of SP-8203 and Placebo in Ischemic Stroke, sponsored by Shin Poong Pharmaceutical Co. Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-03-08.
Sponsored by Shin Poong Pharmaceutical Co. Ltd. · Phase 2, Interventional, and Treatment
This clinical trial is designed to evaluate the efficacy and safety of the combination therapy of SP-8203 (Otaplimastat) and recombinant tissue Plasminogen Activator (rtPA) standard of care. In this clinical trial, rtPA will be injected intravenously using an infusion device. If reperfusion is not occur in spite of rtPA therapy, endovascular therapy can be performed.
This clinical trial is designed to evaluate the efficacy and safety of the combination therapy of SP-8203 and rtPA in patients with acute ischemic stroke receiving rtPA standard of care.
As the standard procedure of rtPA therapy, rtPA will be injected intravenously using an infusion device. When reperfusion is not achieved in spite of rtPA therapy, endovascular therapy can be performed according to the judgment of a site investigator.
A total of 178 subjects will be enrolled in double-blind, randomized and parallel design with 89 subjects assigned to 80 mg/day SP-8203 group or placebo group, respectively.
If a subject, who is able to be enrolled, has neurologic deficit of ≥4 point on the National Institute of Health Stroke Scale (NIHSS) score and give his/her consent to participate in the trial, each treatment is administered after the investigational product is randomly assigned by institution after sequential allocation. The randomization number of patients is the same as the assigned number of the investigational product administered to the patients. The subject will receive the Investigational products a total of 6 times, with 12 hours intervals. Only for the patients who consent, blood sample will be taken after the sixth administration of the Investigational product for pharmacokinetic and pharmacodynamics analysis. For pharmacokinetic profile analysis, blood sample will be taken at 0\~5, 30±5, and 120±5 minutes after the complete sixth administration of the investigational products. For pharmacodynamic profile analysis, blood sample will be taken at between 24 to 48 hours after the first administration, at 0 minute after the sixth administration and at 4th week visit. The first blood sampling time is set to after 24 hours because of the patient's stability, but it can be performed before the investigational product has been administered in accordance with the judgment of the investigators.
The subject will have brain initial Magnetic Resonance Imaging (MRI) and Magnetic Resonance Angiography (MRA) performed within 6 hours before and after the administration of investigational product, and brain Computed Tomography (CT) will be performed at 24±3 hours after completion of the first administration of investigational products.
Brain MRI and MRA will be followed-up on Day 5, and additionally the subject will make a visit for close monitoring for his/her neurologic condition at 4th week and 12th week. Thereafter, all the procedures of the clinical trial will be completed.
When unexpected serious adverse reaction occurs during the clinical trial, the safety of subjects who participated in clinical trial and the clinical trial itself is objectively validated through the convocation and evaluation by Data Safety Monitoring Board (DSMB).
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's enrollment of 178 is above the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →Shin Poong Pharmaceutical Co. Ltd. is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients showing the following abnormal ECG findings in stable condition at Emergency Room:
SP-8203 80 mg (40 mg/dose twice a day for three days)
Drug: SP-8203
Placebo group: twice a day for three days
Drug: Placebo
SP-8203 80 mg will be intravenously administered as 40 mg/dose twice daily (intervals of 12 hours)
Also known as: Otaplimastat (SP-8203)
Placebo will be intravenously administered twice daily (intervals of 12 hours)
The neurological improvement evaluated by the National Institute of Health Stroke Scale (NIHSS)
The neurological improvement evaluated by the National Institute of Health Stroke Scale (NIHSS) until 28 day in subjects with acute ischemic stroke requiring rtPA (recombinant tissue Plasminogen Activator) standard of care. The maximum total score is 42 points, which indicates the most critical condition and the minimum total score is 0, which indicates no neurologic deficit.
Time frame: Change from 0 day at 28 days
Incidence of parenchymal hematoma observed on brain Computed Tomography (CT) scan
Incidence of parenchymal hematoma observed on brain Computed Tomography (CT) scan performed at 24±3 hours in accordance with European Cooperative Acute Stroke Study (ECASS) I and II criteria, after the administration of SP-8203 in conjunction with rtPA standard of care
Time frame: Day 1
The difference in the distribution of modified Rankin Scale (mRS) scores
The difference in the distribution of modified Rankin Scale (mRS) scores in subjects with acute ischemic stroke requiring rtPA standard of care. The 0-6 point-scales are scored according to symptoms with 0 point indicating no disability; the higher score denotes ofr the more severe degree of disability.
Time frame: Day 90
The change in the National Institute of Health Stroke Scale (NIHSS) scores
The change in the National Institute of Health Stroke Scale (NIHSS) scores until 90 day in subjects with acute ischemic stroke requiring rtPA standard of care. The maximum total score is 42 points, which indicates the most critical condition and the minimum total score is 0, which indicates no neurologic deficit.
Time frame: Change from 0 day at 90 days
The change in Barthel index
The change in Barthel index in subjects with acute ischemic stroke requiring rtPA standard of care
Time frame: Change from 0 day at 90 days
The fold change of infarct growth classified by modified Treatment in Cerebral Ischemia (mTICI) grade within 5 days
MRI (DWI) imaging outcomes
Time frame: Day 5
The number of occurrence and volume of intracranial hemorrhage classified by mTICI grade within 5 days
MRI (GRE) imaging outcomes
Time frame: Day 5
The incidence of serious adverse events
The incidence of serious adverse events
Time frame: follow-up to 30 days after the last visit
The rate of death
The rate of death due to any cause
Time frame: follow-up to 30 days after the last visit
The incidence rate of adverse events, and adverse drug reaction
The incidence rate of adverse events, and adverse drug reaction
Time frame: follow-up to 30 days after the last visit
The incidence of symptomatic Intracranial Hemorrhage (sICH)
The incidence of sICH occurring within 5 days of administration according to the definition described on the protocol
Time frame: within 5 days of administration
The Incidence of major systemic bleeding
The Incidence of major systemic bleeding according to the International Society of Thrombosis and Hemostasis (ISTH) definition
Time frame: within 5 days of administration
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Shin Poong Pharmaceutical Co. Ltd.