Evaluating SP-8203 for treating acute ischemic stroke alongside standard thrombolytic care
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
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 |
| Enrollment | 852 (estimated) |
| Ages | 19 Years to 85 Years |
| Sex | All |
| Sponsor | Shin Poong Pharmaceutical Co. Ltd. Industry-sponsored |
| Locations | 2 sites (Busan and 1 other locations) |
| Trial ID | NCT06660719 on ClinicalTrials.gov |
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).
Who should consider this trial
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.
Not a fit: Patients with recent myocardial infarction, significant arrhythmias, or systemic allergic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve recovery outcomes for patients suffering from acute ischemic stroke.
How similar studies have performed: Other studies have shown promise with neuroprotectants in stroke treatment, but the specific combination of SP-8203 with thrombolytic therapy is novel.
Eligibility criteria
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 this trial is running
Busan and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.