drugset / Trial / NCT06660719

Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Receiving Thrombolytic Standard of Care

NCT06660719 ↗

Phase 3 Recruiting 852 enrolled Shin Poong Pharmaceutical Co. Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

This clinical study is designed to evaluate the efficacy and safety of the combination therapy of SP-8203 (otaplimastat) and thrombolytic standard of care in acute ischemic stroke patient. As a standard of care, thrombolytic therapy (for instance, recombinant tissue plasminogen activator) will be administered. When reperfusion is not achieved in spite of thrombolytic therapy, endovascular therapy can be performed.

Timeline

Start
2025-02-14
Primary completion
2027-03-30
Completion
2027-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject OTAPLIMASTAT Small molecule 40 mg Intravenous

Indications