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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
The goal of this study is to evaluate the safety and efficacy of JX10 versus placebo in participants with Acute Ischemic Stroke (AIS) who present for care within 4.5 to 24 hours. The main question the study aims to answer are: 1. JX10 improves functional outcomes as measured by the modified Rankin Scale score when compared with placebo following AIS. 2. Risk of symptomatic intracranial hemorrhage of JX10 in participants with AIS. During Part 1, participants will be randomized to JX 10 (1mg/kg, 3 mg/kg) or placebo. During Part 2, participants will receive JX10 (optimal dose chosen from Part 1) or placebo.
Age
18 - 90 years
Sex
ALL
Healthy Volunteers
No
Corxel Investigational Site
Long Beach, California, United States
Corxel Investigational Site
Sacramento, California, United States
Corxel Investigational Site
Colorado Springs, Colorado, United States
Corxel Investigational Site
Washington D.C., District of Columbia, United States
Corxel Investigational Site
Delray Beach, Florida, United States
Corxel Investigational Site
Chicago, Illinois, United States
Corxel Investigational Site
Wichita, Kansas, United States
Corxel Investigational Site
Baltimore, Maryland, United States
Corxel Investigational Site
Kalamazoo, Michigan, United States
Corxel Investigational Site
Traverse City, Michigan, United States
Start Date
May 15, 2025
Primary Completion Date
October 31, 2029
Completion Date
December 31, 2029
Last Updated
March 13, 2026
740
ESTIMATED participants
JX10
DRUG
Placebo
DRUG
Lead Sponsor
Corxel Pharmaceuticals
NCT07253181
NCT07001267
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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