Efficacy and Safety of SP-8203 in Patients With Ischemic Stroke Requiring rtPA

NCT04479449 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: SP-8203-2002
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is designed to evaluate the efficacy and safety of the combination therapy of SP-8203 (Otaplimastat) and recombinant tissue Plasminogen Activator (rtPA) standard of care. In this clinical trial, rtPA will be injected intravenously using an infusion device. If reperfusion is not occur in spite of rtPA therapy, endovascular therapy can be performed.

Conditions

Ischemic Stroke

Keywords

SP-8203 (Otaplimastat); rtPA (recombinant tissue Plasminogen Activator)

Outcome Measures

Primary Outcomes (1)

• The neurological improvement evaluated by the National Institute of Health Stroke Scale (NIHSS)

  The neurological improvement evaluated by the National Institute of Health Stroke Scale (NIHSS) until 28 day in subjects with acute ischemic stroke requiring rtPA (recombinant tissue Plasminogen Activator) standard of care. The maximum total score is 42 points, which indicates the most critical condition and the minimum total score is 0, which indicates no neurologic deficit.

  Change from 0 day at 28 days

Secondary Outcomes (11)

• Incidence of parenchymal hematoma observed on brain Computed Tomography (CT) scan

  Day 1

• The difference in the distribution of modified Rankin Scale (mRS) scores

  Day 90

• The change in the National Institute of Health Stroke Scale (NIHSS) scores

  Change from 0 day at 90 days

• The change in Barthel index

  Change from 0 day at 90 days

• The fold change of infarct growth classified by modified Treatment in Cerebral Ischemia (mTICI) grade within 5 days

  Day 5

Study Arms (2)

SP-8203

EXPERIMENTAL

SP-8203 80 mg (40 mg/dose twice a day for three days)

Drug: SP-8203

Placebo

PLACEBO COMPARATOR

Placebo group: twice a day for three days

Drug: Placebo

Interventions

SP-8203 DRUG

SP-8203 80 mg will be intravenously administered as 40 mg/dose twice daily (intervals of 12 hours)

Also known as: Otaplimastat (SP-8203)

SP-8203

Placebo DRUG

Placebo will be intravenously administered twice daily (intervals of 12 hours)

Placebo

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with neurologic deficit of ≥ 4 points by NIHSS score
• Adults aged ≥19 years and ≤85 years. (Pre-stroke mRS must be 0 or 1; No significant pre-stroke disability)
• Subjects who can receive rtPA therapy within 4.5 hours after the onset of early symptoms of acute ischemic stroke.
• Subjects available for brain MRI (DWI, GRE/Susceptibility Weighted Imaging (SWI), FLAIR, MRA) scanning
• Subjects who consent to participate in this trial.

You may not qualify 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
• nd 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 age can participate in the trial only when non-pregnancy is confirmed. Woman of childbearing age is defined as woman who is not definitely menopause and did not receive a surgical contraception.

Sponsors & Collaborators

• Shin Poong Pharmaceutical Co. Ltd.: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

otaplimastat

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jong Sung Kim, MD, Phd

  Asan Medical Center

  STUDY CHAIR

• Dae-IL Chang, MD, Phd

  Kyunghee University Medical Center

  PRINCIPAL INVESTIGATOR

• Kyung Mi Oh, MD, Phd

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

• Jong-Ho Park, MD, Phd

  Myongji Hospital

  PRINCIPAL INVESTIGATOR

• Kyung Bok Lee, MD, Phd

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

• Sang Min Sung, MD, Phd

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

• Eung-Gyu Kim, MD, Phd

  Inje University

  PRINCIPAL INVESTIGATOR

• Hee-Joon Bae, MD, Phd

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

• Jee-Hyun Kwon, MD, Phd

  Ulsan University Hospital

  PRINCIPAL INVESTIGATOR

• Jae Gwan Cha, MD, Phd

  Dong-A University Hospital

  PRINCIPAL INVESTIGATOR

• Man Seok Park, MD, Phd

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

• Jong Moo Park, MD, Phd

  Nowon Eulji Medical Center

  PRINCIPAL INVESTIGATOR

• Yang Ha Hwang, MD, Phd

  Kyungpook National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 21, 2020
• Study Start: March 18, 2019
• Primary Completion: October 19, 2020
• Study Completion: December 18, 2020
• Last Updated: March 8, 2023

Record last verified: 2023-03

Locations

KR (1)