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Tests treatment safety and results for Ischemic Stroke
Official title Efficacy and Safety of SP-8203 (Otaplimastat) in Patients With Acute Ischemic Stroke Receiving Thrombolytic Standard of Care
ClinicalTrials.gov ID: NCT06660719
What this study is testing
What is SP-8203?
SP-8203 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for ischemic stroke.
Also referred to as Otaplimastat (SP-8203).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 85
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Busan, South Korea
- Ulsan, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Busan, South Korea; Ulsan, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.