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

Status: Recruiting
Location: See all (76) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• Age ≥ 18 and ≤ 90 years old.

• Acute ischemic stroke with compatible clinical presentation and symptomatic high grade or complete occlusion of the intracranial internal carotid, M1, M2 or distal branches of the middle cerebral artery (MCA), anterior cerebral artery (ACA), or posterior cerebral artery (PCA).

• Radiographic evidence of salvageable tissue.

• Pre-treatment score of NIHSS ≥ 5.

Locations
United States
California
Corxel Investigational Site
RECRUITING
Long Beach
Corxel Investigational Site
RECRUITING
Sacramento
Colorado
Corxel Investigational Site
RECRUITING
Colorado Springs
Washington, D.c.
Corxel Investigational Site
RECRUITING
Washington D.c.
Florida
Corxel Investigational Site
RECRUITING
Delray Beach
Illinois
Corxel Investigational Site
RECRUITING
Chicago
Kansas
Corxel Investigational Site
RECRUITING
Wichita
Maryland
Corxel Investigational Site
RECRUITING
Baltimore
Michigan
Corxel Investigational Site
RECRUITING
Kalamazoo
Corxel Investigational Site
RECRUITING
Traverse City
Missouri
Corxel Investigational Site
RECRUITING
St Louis
New York
Corxel Investigational Site
RECRUITING
Great Neck
Corxel Investigational Site
RECRUITING
New York
Ohio
Corxel Investigational Site
RECRUITING
Toledo
Oklahoma
Corxel Investigational Site
RECRUITING
Tulsa
Texas
Corxel Investigational Site
RECRUITING
Dallas
Corxel Investigational Site
RECRUITING
Houston
Other Locations
Belgium
Corxel Investigational Site
RECRUITING
Ghent
Bulgaria
Corxel Investigational Site
RECRUITING
Blagoevgrad
Corxel Investigational Site
RECRUITING
Burgas
Corxel Investigational Site
RECRUITING
Pleven
Corxel Investigational Site
RECRUITING
Plovdiv
Corxel Investigational Site
RECRUITING
Sofia
Canada
Corxel Investigational Site
RECRUITING
Edmonton
Corxel Investigational Site
RECRUITING
Kingston
China
Corxel Investigational Site
RECRUITING
Baotou
Corxel Investigational Site
RECRUITING
Beijing
Corxel Investigational Site
RECRUITING
Beijing
Corxel Investigational Site
RECRUITING
Changchun
Corxel Investigational Site
RECRUITING
Guangzhou
Corxel Investigational Site
RECRUITING
Harbin
Corxel Investigational Site,
RECRUITING
Harbin
Corxel Investigational Site
RECRUITING
Kaili
Corxel Investigational Site
RECRUITING
Linfen
Corxel Investigational Site
RECRUITING
Shanghai
Corxel Investigational Site
RECRUITING
Shenyang
Corxel Investigational Site
RECRUITING
Suzhou
Corxel Investigational Site
RECRUITING
Weifang
Corxel Investigational Site
RECRUITING
Xuzhou
Germany
Corxel Investigational Site
RECRUITING
Altenburg
Corxel Investigational Site
RECRUITING
Leipzig
Corxel Investigational Site
RECRUITING
Lübeck
Greece
Corxel Investigational Site
RECRUITING
Athens
Corxel Investigational Site
RECRUITING
Chaïdári
Corxel Investigational Site
RECRUITING
Thessaloniki
Italy
Corxel Investigational Site
RECRUITING
Pavia
Corxel Investigational Site
RECRUITING
Roma
Japan
Corxel Investigational Site
RECRUITING
Fukuoka
Corxel Investigational Site
RECRUITING
Hyōgo
Corxel Investigational Site
RECRUITING
Kamakura
Corxel Investigational Site
RECRUITING
Mitaka
Corxel Investigational Site
RECRUITING
Miyagi
Corxel Investigational Site
RECRUITING
Yamagata
Corxel Investigational Site
RECRUITING
Yamaguchi
Latvia
Corxel Investigational Site
RECRUITING
Daugavpils
Corxel Investigational Site
RECRUITING
Riga
Lithuania
Corxel Investigational Site
RECRUITING
Kaunas
Corxel Investigational Site
RECRUITING
Vilnius
Malaysia
Corxel Investigational Site
RECRUITING
Kuching
Portugal
Corxel Investigational Site
RECRUITING
Braga
Corxel Investigational Site
RECRUITING
Loures
Republic of Korea
Corxel Investigational Site
RECRUITING
Seoul
Serbia
Corxel Investigational Site
RECRUITING
Belgrade
Corxel Investigational Site
RECRUITING
Kragujevac
Corxel Investigational Site
RECRUITING
Niš
Corxel Investigational Site
RECRUITING
Novi Sad
Spain
Corxel Investigational Site
RECRUITING
A Coruña
Corxel Investigational Site
RECRUITING
Albacete
Corxel Investigational Site
RECRUITING
Barcelona
Corxel Investigational Site
RECRUITING
Girona
Corxel Investigational Site
RECRUITING
Madrid
Corxel Investigational Site
RECRUITING
Málaga
Corxel Investigational Site
RECRUITING
Seville
Corxel Investigational Site
RECRUITING
Valencia
Thailand
Corxel Investigational Site
RECRUITING
Bangkok
Corxel Investigational Site
RECRUITING
Khon Kaen
Contact Information
Primary
Corxel Pharmaceuticals Study Information Center
Information.center@corxelbio.com
201-268-3723
Time Frame
Start Date: 2025-05-15
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 740
Treatments
Experimental: Part 1 - JX10 (1mg/kg)
Experimental: Part 1 - JX10 (3mg/kg)
Placebo_comparator: Part 1 - Placebo
Experimental: JX10 Part 2 - (1 or 3 mg/kg)
Placebo_comparator: Part 2 - Placebo
Related Therapeutic Areas
Sponsors
Leads: Corxel Pharmaceuticals

This content was sourced from clinicaltrials.gov