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Safety and Efficacy of SP-8203 in Acute Ischemic Stroke
NCT02787278Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2016
- Primary completion
- May 2017
- Countries
- 1
- Sponsor
- Shinpoong Pharma
- Modality
- Orthosteric Ligands
- Drugs
- otaplimastat
- Conditions
- ischemic stroke
01
Overview
Phase 2, randomised, double-blind trial of otaplimastat in ischemic stroke (3 arms), sponsored by Shinpoong Pharma. Primary endpoint: The ratio of the incidence of parenchymal hematoma observed on brain CT at 24 hours. Started Jun 2016; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
SP-8203 High dose group
SP-8203 160mg/day (80mg BID) + rtPA
SP-8203 Low dose group
SP-8203 80mg/day (40mg BID) + rtPA
Placebo group
Placebo + rtPA
03
Who it enrols
Adult patients (19-80 years) with acute ischemic stroke eligible for rtPA therapy within 4.5 hours of onset. NIHSS score >= 4. Exclusion criteria include recent MI, severe heart failure, and high bleeding risk.
04
Endpoints
Primary
The ratio of the incidence of parenchymal hematoma observed on brain CT
Secondary
Incidence rate of serious adverse events
Neurologic outcomes evaluated by modified Rankin Scale
Incidence rate symptomatic intracranial hemorrhage
Neurologic outcomes evaluated by NIHSS
Neurologic outcomes evaluated by Barthel Index
The rate of death due to any cause
Incidence rate of adverse events and adverse drug reactions
Incidence rate of major systemic bleeding according to the International Society on Thrombosis and Hemostasis
05
Results
Not all primary endpoints met
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