RECRUITING

Optimizing Reperfusion to Improve Outcomes and Neurologic Function

Conditions

Acute Ischemic Stroke reperfusion ORION Late Presentation JX10 thrombolytic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-05-15

Study Completion:2029-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06990867

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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. Significant mass effect or clinically significant cerebral edema, or 4. Evidence of acute intracranial or extracranial hemorrhage, intracranial tumor (except small meningioma), neoplasm, or arteriovenous malformation), or 5. Clinical history, past imaging, or clinical judgement suggests that the intracranial occlusion is chronic. 2. Medical history or active clinically significant bleeding, lesions, or conditions (at the investigator's judgement) considered to be of significant risk for major bleeding. 3. Severe, uncontrolled hypertension (systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg) that cannot be controlled with antihypertensive therapy. 4. Known bleeding diathesis (hereditary or acquired) or any significant coagulopathy. Specifically, platelet count \< 100,000/μL, international normalized ratio \> 1.7, aPTT \> 40 seconds, or prothrombin time \> 15 seconds. 5. Major trauma, surgery, or invasive procedures. 6. Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations of this study. 7. Pre-treatment blood glucose \> 400 mg/dL (22.20 mmol/L) or Pre-treatment blood glucose \< 50 mg/dL (2.78 mmol/L) unless it is corrected prior to study treatment administration. Participants with subsequently normalized blood glucose levels may be considered for inclusion, per Investigator judgement.

Inclusion Criteria

Exclusion 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.

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. Significant mass effect or clinically significant cerebral edema, or
4. Evidence of acute intracranial or extracranial hemorrhage, intracranial tumor (except small meningioma), neoplasm, or arteriovenous malformation), or
5. Clinical history, past imaging, or clinical judgement suggests that the intracranial occlusion is chronic.
2. Medical history or active clinically significant bleeding, lesions, or conditions (at the investigator's judgement) considered to be of significant risk for major bleeding.
3. Severe, uncontrolled hypertension (systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg) that cannot be controlled with antihypertensive therapy.
4. Known bleeding diathesis (hereditary or acquired) or any significant coagulopathy. Specifically, platelet count \< 100,000/μL, international normalized ratio \> 1.7, aPTT \> 40 seconds, or prothrombin time \> 15 seconds.
5. Major trauma, surgery, or invasive procedures.
6. Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations of this study.
7. Pre-treatment blood glucose \> 400 mg/dL (22.20 mmol/L) or Pre-treatment blood glucose \< 50 mg/dL (2.78 mmol/L) unless it is corrected prior to study treatment administration. Participants with subsequently normalized blood glucose levels may be considered for inclusion, per Investigator judgement.

Contacts and Locations

Study Contact

Corxel Pharmaceuticals Study Information Center

CONTACT

201-268-3723

Information.center@corxelbio.com

Principal Investigator

Senior Director, Clinical Operations

STUDY_DIRECTOR

Corxel Pharmaceuticals

Study Locations (Sites)

Corxel Investigational Site

Chicago, Illinois, 60616

United States

Collaborators and Investigators

Sponsor: Corxel Pharmaceuticals

Senior Director, Clinical Operations, STUDY_DIRECTOR, Corxel Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-15

Study Completion Date2029-12-31

Study Record Updates

Study Start Date2025-05-15

Study Completion Date2029-12-31

Terms related to this study

Keywords Provided by Researchers

reperfusion
ORION
Acute Ischemic Stroke
Late Presentation
JX10
thrombolytic

Additional Relevant MeSH Terms

Acute Ischemic Stroke