SP-8203 for Acute Ischemic Stroke Treatment

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

Recruiting Phase 3 Interventional Study
Ischemic Stroke
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
19 – 85
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
852 (estimated)
Sponsor
Shin Poong Pharmaceutical Co. Ltd. · Industry
Who this trial is looking for

This trial is looking for adults who have had an acute ischemic stroke and are receiving standard treatment. Participants will be given a new treatment alongside their usual care to see how well it works and if it is safe.

Are You a Good Fit for This Trial?
Rules you out Cancer diagnosed in the last 6 monthsSevere heart diseaseSevere lung disease

You may be able to join if

  • I have a neurologic deficit of 8 or more on the NIH Stroke Scale.
  • I was able to carry out my usual activities before the stroke.
  • I am between 19 and 85 years old.
  • I can receive standard thrombolytic treatment within 4.5 hours of stroke symptoms.
  • I am available for a brain MRI scan.
  • I agree to participate in this study.

You may not be able to join if

  • I have had a heart attack in the last 6 months.
  • I have experienced serious heart rhythm problems in the last 6 months.
  • I have severe heart failure.
  • I have signs of infection that require antibiotics.
  • I have a history of certain serious lung diseases recently.
  • I have low hemoglobin or platelet counts.
  • I am pregnant or breastfeeding.
  • I do not agree to use contraception for 90 days after the treatment.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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…
Trial Locations
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Eligibility 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 …
Contacts

Jong Sung Kim, MD, Phd

+82-33-610-3114

jongskim@amc.seoul.kr

CONTACT

Byung Su Kim, MS

+82-70-5168-6503

135kbs@shinpoong.co.kr

CONTACT