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

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

Interventions

DRUG

SP-8203

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

DRUG

Placebo

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

Sponsors & Collaborators

• Shin Poong Pharmaceutical Co. Ltd.

  lead INDUSTRY

Principal Investigators

• Jong Sung Kim, MD, Phd · Asan Medical Center

• Dae-IL Chang, MD, Phd · Kyunghee University Medical Center

• Kyung Mi Oh, MD, Phd · Korea University Guro Hospital

• Jong-Ho Park, MD, Phd · Myongji Hospital

• Kyung Bok Lee, MD, Phd · Soonchunhyang University Hospital

• Sang Min Sung, MD, Phd · Pusan National University Hospital

• Eung-Gyu Kim, MD, Phd · Inje University

• Hee-Joon Bae, MD, Phd · Seoul National University Bundang Hospital

• Jee-Hyun Kwon, MD, Phd · Ulsan University Hospital

• Jae Gwan Cha, MD, Phd · Dong-A University Hospital

• Man Seok Park, MD, Phd · Chonnam National University Hospital

• Jong Moo Park, MD, Phd · Nowon Eulji Medical Center

• Yang Ha Hwang, MD, Phd · Kyungpook National University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-18

Primary Completion

2020-10-19

Completion

2020-12-18

FDA Drug

Yes

Countries

• South Korea

Study Locations