Optimizing Reperfusion to Improve Outcomes and Neurologic Function (ORION)
Research type
Research Study
Full title
Optimizing Reperfusion to Improve Outcomes and Neurologic Function (ORION): A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Phase 2/3 Study to Evaluate the Efficacy and Safety of JX10 in Acute Ischemic Stroke with Late Presentations
IRAS ID
1011553
Contact name
Kevin Schutz
Contact email
Sponsor organisation
Corxel Pharmaceuticals Co. Ltd.
Research summary
This is a study of the experimental medicine JX10 in participants with an ischemic stroke, a blockage of the blood flow to a part of the brain, caused by a blood clot. Only people who are having or have just had an ischemic stroke can take part in the study with the first sign of stroke symptoms less than 24 hours ago. JX10 is a thrombolytic medication that is designed to break down clots that block the arteries. This breakdown would help to restore the blood flow (also known as reperfusion) in the part of the brain that has been affected by the ischemic stroke. The study will evaluate the effects of JX10 compared to placebo. Placebo looks like the experimental medicine but does not contain any active ingredient. In this document JX10 and placebo are both called “study medicine”. While participants are admitted to the hospital, they will go through a screening period to find out if they can continue and receive the study medicine. Participants will be randomly assigned by chance (JX10 or placebo). Then they will be followed for about 90 days. The study medicine will be given by intravenous infusion (into the vein). Participants will have tests such as but not limited to: blood and urine tests, physical exams, electrocardiograms (to see how the heart is functioning), continuous cardiac monitoring (continuous measurement of ECG and other parameters through a small device placed on the participant’s chest), brain image assessments (by CT or MRI), and questionnaires about their quality of life.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
25/NE/0181
Date of REC Opinion
13 Nov 2025
REC opinion
Further Information Favourable Opinion