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
Corxel Pharmaceuticals
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
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18 and ≤ 90 years old. 2. 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). 3. Radiographic evidence of salvageable tissue. 4. Pre-treatment score of NIHSS ≥ 5. Exclusion Criteria: 1. Radiographic findings pre-randomization of any of the following: 1. Large core infarction, or 2. Occlusion in more than 1 vascular territory, or 3…
Interventions
- DrugJX10
JX10 is a thrombolytic agent.
- DrugPlacebo
Placebo is being used as the comparator.
Locations (83)
- Corxel Investigational SiteLong Beach, California
- Corxel Investigational SiteSacramento, California
- Corxel Investigational SiteColorado Springs, Colorado
- Corxel Investigational SiteWashington D.C., District of Columbia
- Corxel Investigational SiteDelray Beach, Florida
- Corxel Investigational SiteChicago, Illinois