NCT02787278

Brief Summary

The current study aims to evaluate the safety of SP-8203, designing in two stages (stage-1, stage-2) to evaluate the safety and efficacy of the combination therapy of SP-8203 and rtPA for the occurrence of cerebral hemorrhage in patients with acute ischemic stroke receiving rtPA standard of care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

June 5, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2017

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

12 months

First QC Date

May 18, 2016

Last Update Submit

July 20, 2020

Conditions

Ischemic Stroke

Keywords

rtPAIntracranial hemorrhage

Outcome Measures

Primary Outcomes (1)

  • The ratio of the incidence of parenchymal hematoma observed on brain CT

    Incidence of parenchymal hematoma observed on brain CT performed at 24 hours in accordance with European Cooperative Acute Stroke Study (ECASS) I and II criteria

    Brain CT should be performed at 24 ± 3 hours after the complete administration of the first dose of IP. (Screening, Baseline ,Day 0, Day 1)

Secondary Outcomes (8)

  • Incidence rate of serious adverse events

    Follow up period is 30 days after the last visit.

  • Neurologic outcomes evaluated by modified Rankin Scale (mRS)

    Screening, Baseline, Day 0, Day 5, Week 12, Early Termination

  • Incidence rate symptomatic intracranial hemorrhage (sICH) occuring within 5 days

    Day 1 Brain CT, Day 5 Brain MRI

  • Neurologic outcomes evaluated by NIHSS

    NIHSS should be scored every visit

  • Neurologic outcomes evaluated by Barthel Index

    Day 0, Day 5, Week 12, Early Termination

  • +3 more secondary outcomes

Study Arms (3)

SP-8203 High dose group

EXPERIMENTAL

SP-8203 160mg (80mg/dose twice a day for three days)

Drug: SP-8203 High dose

SP-8203 Low dose group

EXPERIMENTAL

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

Drug: SP-8203 Low dose

Placebo group

PLACEBO COMPARATOR

Placebo group: twice a day for three days

Drug: Placebo

Interventions

SP-8203 High doseDRUG

High-dose group: 160mg will be intravenously administered as 80mg/dose twice daily (intervals of 12 hours).

Also known as: SP-8203 is produced by Shin Poong Pharmaceutical company
SP-8203 High dose group
SP-8203 Low doseDRUG

Low dose group: 80mg will be intravenously administered as 40mg/dose twice daily (intervals of 12 hours).

Also known as: SP-8203 is produced by Shin Poong Pharmaceutical company
SP-8203 Low dose group
PlaceboDRUG

Same dosage of SP8203. Placebo will be intravenously administered twice daily (intervals of 12 hours)

Placebo group

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage 1-specific Criteria Patients with neurologic deficit of ≥4 points and ≤10 points by NIHSS score.
  • Stage 2-specific Criteria Patients with neurologic deficit of ≥4 points by NIHSS score.
  • Common Criteria for Stage 1 and Stage 2
  • Adults aged ≥19 years and ≤80 years.
  • Subjects fulfilling the criteria for rtPA therapy. ① Subjects who can receive rtPA therapy within 4.5 hours after the onset of early symptoms of acute ischemic stroke.
  • ② Subjects requiring rtPA therapy according to the judgment of a neurologist.
  • Subjects available for brain MRI (DWI, GRE/SWI \[Susceptibility Weighted Imaging\], 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 have condition as follows:
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  • Patients who were diagnosed with acute myocardial infarction (AMI) within the last 6 months.
  • Patients who had arrhythmia causing symptoms such as dyspnea or palpitation within the last 6 months.
  • Patients showing the following abnormal ECG findings in stable condition at screening:
  • The range of pulse rate - below 60/min or above 120/min
  • nd or 3rd degree AV(Atrioventricular) block indicated in ECG
  • Congenital or acquired QT syndrome indicated in ECG
  • ④ Pre-excitation syndrome indicated in ECG
  • \) Patients with severe heart failure of NYHA(New York Heart Association) Class III or Class IV.
  • NYHA classification of heart failure defined as:
  • Class I: patients with no limitation of activities; they suffer no symptoms from ordinary activities.
  • Class II: patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion.
  • Class III: patients with marked limitation of activity; they are comfortable only at rest.
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Pusan National University Hospital

Busan, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

Myongji Hospital

Gyeonggi-do, South Korea

Location

Inje University Busan Paik Hospital

Pusan, South Korea

Location

Asan Medical Center, University of Ulsan

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

KyungHee University Medical Center

Seoul, South Korea

Location

Soonchunhyang University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Kim JS, Lee KB, Park JH, Sung SM, Oh K, Kim EG, Chang DI, Hwang YH, Lee EJ, Kim WK, Ju C, Kim BS, Ryu JM; SAFE-TPA Investigators. Safety and Efficacy of Otaplimastat in Patients with Acute Ischemic Stroke Requiring tPA (SAFE-TPA): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study. Ann Neurol. 2020 Feb;87(2):233-245. doi: 10.1002/ana.25644. Epub 2019 Nov 29.

    PMID: 31721277DERIVED

MeSH Terms

Conditions

Ischemic StrokeIntracranial Hemorrhages

Interventions

otaplimastat

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jong Sung Kim, MD, Phd

    Department of Neurology, Asan Medical Center, Seoul, South Korea

    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

May 18, 2016

First Posted

June 1, 2016

Study Start

June 5, 2016

Primary Completion

May 30, 2017

Study Completion

August 22, 2017

Last Updated

July 21, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(8)