Evaluating SP-8203 for treating acute ischemic stroke alongside standard thrombolytic care
Official title: A Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled, Phase III Clinical Study to Evaluate Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Requiring Thrombolytic Therapy as Standard of Care
Run by Shin Poong Pharmaceutical Co. Ltd. · NCT06660719 · Data updated 2026-11-12
This study is testing if adding a new drug called SP-8203 to standard treatment can help people with acute ischemic stroke recover better and improve their brain function.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years to 85 Years |
| Sex | All |
| Enrollment | 852 (estimated) |
| Sponsor | Shin Poong Pharmaceutical Co. Ltd. Industry-sponsored |
| Locations | 2 sites (Busan and 1 other locations) |
| Status | Recruiting |
| Started | February 14, 2025 |
| Main results expected | March 30, 2027 |
| Study ends | March 30, 2027 |
| Registry record updated | March 7, 2025 |
| Trial ID | NCT06660719 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 19 to 85 with a neurologic deficit of 8 or more on the NIHSS who can receive thrombolytic therapy within 4.5 hours of symptom onset.
✕Probably not a fit
Patients with recent myocardial infarction, significant arrhythmias, or systemic allergic diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical study aims to assess the efficacy and safety of SP-8203 (otaplimastat) when used in combination with standard thrombolytic therapy in patients experiencing acute ischemic stroke. A total of 852 participants will be enrolled in a double-blind, randomized, parallel design, with half receiving SP-8203 and the other half receiving a placebo. Participants will undergo brain imaging tests before and after treatment to evaluate the intervention's impact on infarct volume and neurological recovery. The study will focus on patients with a significant neurologic deficit as measured by the National Institute of Health Stroke Scale (NIHSS).
Why it matters
Potential benefit: If successful, this treatment could improve recovery outcomes for patients suffering from acute ischemic stroke.
How similar studies have gone: Other studies have shown promise with neuroprotectants in stroke treatment, but the specific combination of SP-8203 with thrombolytic therapy is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with neurologic deficit of ≥ 8 points by National Institute of Health Stroke Scale (NIHSS) score * Patients with pre-stroke modified Rankin Scale (mRS) must be 0 or 1, which means they were able to carry out all usual duties and activities * Adults aged ≥19 years and ≤85 years * Patients who can receive thrombolytic standard of care within 4.5 hours after the onset of early symptoms of acute ischemic stroke * Patients available for brain Magnetic Resonance Imaging (MRI) scanning * Patients who consent to participate in this study Exclusion Criteria: * Patients with systemic allergic diseases or hypersensitivity to specific drugs. * Patients who were diagnosed with myocardial infarction (MI) within the last 6 months. * Patients who had arrhythmia causing clinical symptoms such as dyspnea or palpitation within the last 6 months. * Patients showing the following abnormal ECG findings in stable condition at Emergency Room: * The range of pulse rate - under 55/min or exceed 120/min * 2nd or 3rd degree Atrioventricular (AV) block indicated in ECG * Congenital or acquired QT syndrome indicated in ECG * Pre-excitation syndrome indicated in ECG * Patients with severe heart failure of New York Heart Association (NYHA) Class III or Class IV. * Patients with fever (≥ 38℃) or infection signs which require antibiotic therapy at screening. * Patients with pulmonary diseases (asthma, Chronic Obstruction Pulmonary disease, and active tuberculosis etc.) who have being recently been treated more than 1 month at screening. * Patients with decreased hemoglobin (Hb\< 10g/dL), decreased platelet count (PLT\< 100,000/mm3) or hematocrit of \<25% in complete blood count. * Patients who have undergone hemodialysis and/or treatments due to nephropathies, acute or chronic renal failure at screening. * Patients with a cancer in following conditions: diagnosed within 6 months before the screening time, or any treatment for cancer within the previous 6 months, or with recurrent/ metastatic cancer. * Pregnant and lactating women. However, Women of Childbearing Potential (WOCBP) can participate in the study only when non-pregnancy is confirmed. Women of Childbearing Potential (WOCBP) is defined as woman who is not definitely menopause and did not receive a surgical contraception. * Patients who do not consent to use double barrier contraception until 90 days from the first study intervention administration. * Patients who have participated in other clinical trials of other drugs within the past 3 months. However, if they participated in observational studies and did not take drugs, they can participate in this trial. * Patients who cannot participate in the study at the discretion of investigators * Patients who are unable to receive thrombolytic standard of care, rtPA
Where it's running
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Dong-A University Hospital
Busan, South Korea Recruiting -
Ulsan University Hospital
Ulsan, South Korea Recruiting
Study contacts
- Principal investigator: Beom Jun Kim, MD, Phd — Seoul Asan Medical Center
- Study coordinator: Jong Sung Kim, MD, Phd
- Email: jongskim@amc.seoul.kr
- Phone: +82-33-610-3114
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.