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RECRUITING
NCT06990867
PHASE2/PHASE3

Optimizing Reperfusion to Improve Outcomes and Neurologic Function

Sponsor: Corxel Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Official 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

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

740

Start Date

2025-05-15

Completion Date

2029-12-31

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

JX10

JX10 is a thrombolytic agent.

DRUG

Placebo

Placebo is being used as the comparator.

Locations (83)

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

Corxel Investigational Site

St Louis, Missouri, United States

Corxel Investigational Site

Great Neck, New York, United States

Corxel Investigational Site

New York, New York, United States

Corxel Investigational Site

Toledo, Ohio, United States

Corxel Investigational Site

Tulsa, Oklahoma, United States

Corxel Investigational Site

Dallas, Texas, United States

Corxel Investigational Site

Houston, Texas, United States

Corxel Investigational Site

Ghent, Belgium

Corxel Investigational Site

Blagoevgrad, Bulgaria

Corxel Investigational Site

Burgas, Bulgaria

Corxel Investigational Site

Pleven, Bulgaria

Corxel Investigational Site

Plovdiv, Bulgaria

Corxel Investigational Site

Sofia, Bulgaria

Corxel Investigational Site

Edmonton, Canada

Corxel Investigational Site

Kingston, Canada

Corxel Investigational Site

Baotou, China

Corxel Investigational Site

Beijing, China

Corxel Investigational Site

Beijing, China

Corxel Investigational Site

Changchun, China

Corxel Investigational Site

Guangzhou, China

Corxel Investigational Site,

Harbin, China

Corxel Investigational Site

Harbin, China

Corxel Investigational Site

Kaili, China

Corxel Investigational Site

Linfen, China

Corxel Investigational Site

Shanghai, China

Corxel Investigational Site

Shenyang, China

Corxel Investigational Site

Suzhou, China

Corxel Investigational Site

Weifang, China

Corxel Investigational Site

Xuzhou, China

Corxel Investigational site

Lille, France

Corxel Investigational site

Paris, France

Corxel Investigational Site

Altenburg, Germany

Corxel Investigational Site

Leipzig, Germany

Corxel Investigational Site

Lübeck, Germany

Corxel Investigational Site

Trier, Germany

Corxel Investigational Site

Athens, Greece

Corxel Investigational Site

Chaïdári, Greece

Corxel Investigational Site

Pátrai, Greece

Corxel Investigational Site

Thessaloniki, Greece

Corxel Investigational Site

Pavia, Italy

Corxel Investigational Site

Roma, Italy

Corxel Investigational Site

Fukuoka, Japan

Corxel Investigational Site

Hyōgo, Japan

Corxel Investigational site

Ibaraki, Japan

Corxel Investigational Site

Kamakura, Japan

Corxel Investigational Site

Meguro City, Japan

Corxel Investigational Site

Mitaka, Japan

Corxel Investigational Site

Miyagi, Japan

Corxel Investigational site

Toyota, Japan

Corxel Investigational Site

Yamagata, Japan

Corxel Investigational Site

Yamaguchi, Japan

Corxel Investigational Site

Daugavpils, Latvia

Corxel Investigational Site

Riga, Latvia

Corxel Investigational Site

Kaunas, Lithuania

Corxel Investigational Site

Vilnius, Lithuania

Corxel Investigational Site

Kuching, Malaysia

Corxel Investigational Site

Braga, Portugal

Corxel Investigational Site

Loures, Portugal

Corxel Investigational Site

Belgrade, Serbia

Corxel Investigational Site

Kragujevac, Serbia

Corxel Investigational Site

Niš, Serbia

Corxel Investigational Site

Novi Sad, Serbia

Corxel Investigational Site

Seoul, South Korea

Corxel Investigational Site

A Coruña, Spain

Corxel Investigational Site

Albacete, Spain

Corxel Investigational Site

Barcelona, Spain

Corxel Investigational Site

Girona, Spain

Corxel Investigational Site

Madrid, Spain

Corxel Investigational Site

Málaga, Spain

Corxel Investigational Site

Seville, Spain

Corxel Investigational Site

Valencia, Spain

Corxel Investigational Site

Bangkok, Thailand

Corxel Investigational Site

Khon Kaen, Thailand