Efficacy and Safety of SP-8203 in Patients With Ischemic Stroke Requiring rtPA
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): SP-8203; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SP-8203 80 mg will be intravenously administered as 40 mg/dose twice daily (intervals of 12 hours); Placebo will be intravenously administered twice daily (intervals of 12 hours)
Other intervention name(s): Otaplimastat (SP-8203)
Intervention MeSH terms: Otaplimastat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: SP-8203 (Otaplimastat); rtPA (recombinant tissue Plasminogen Activator)