FindTrial
Sign In

Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke

A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03062397
Enrollment
110
Registered
2017-02-23
Start date
2016-12-09
Completion date
2021-12-31
Last updated
2019-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Brief summary

Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke

Interventions

DRUGJPI-289 Low-dose

JPI-289 Low dose will be intravenously administered during 24 hours

DRUGJPI-289 High-dose

JPI-289 High dose will be intravenously administered during 24 hours

DRUGPlacebo

Same dosage of JPI-289 Low and Hogh dose will be intravenously administered during 24 hours

Sponsors

Jeil Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Subjects with acute ischemic stroke, aging ≥ 19 * Confirmed to have acute anterior circulation cerebral artery occlusion in intracranial internal carotid artery (IICA) or middle cerebral artery (MCA) M1 segment by CT or MR angiography. * National Institutes of Health Stroke Scale(NIHSS) is 6\ 30 before endovascular recanalization therapy (ERT) * Subject who is reperfused with 2b or 3 stages of thrombolysis in cerebral infarction (TICI) (However, if angiography is conducted for thrombectomy after IV tPA treatment and the effect of tPA results in TICI 2b-3 reperfusion, the subject can participate) * Subject who can administer IP within 6.5 hrs of symptom development * Subject who can administer IP within 30 min of vascular reperfusion * Subject who can evaluate MRI within 90 min of vascular reperfusion

Exclusion criteria

* Subject who is contraindicated for endovascular recanalization * Subject who has hypersensitivity to contrast agent or component of investigational product * Prohibited or unable to perform MRI test * Medical history that is related to bleeding * History of hemorrhagic stroke within 6 months of study participation * Subjects with chronic liver disorder * Kidney disorder (Serum creatinine \> 3 mg/dL) * Life expectancy is less than 3 months due to concomitant disease other than stroke * Pregnant or lactating women * Those who have taken tirofiban (anticoagulant agent) during endovascular recanalization therapy * Those who have taken other investigational drugs and/or medical instruments 12 weeks prior to screening * Subject is unable to be followed up * Subject is deemed unable to participate the study in the opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
Infact growth ratio from baseline4 days from baseline

Countries

South Korea

Contacts

Primary ContactByung Woo Yoon, MD., PhD
bwyoon@snu.ac.kr
Backup ContactYong Woo Lee, MSC
ywlee97@jeilpharm.co.kr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026