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Improving outcomes for patients with acute ischemic stroke using JX10

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

Phase2; Phase3 Interventional Corxel Pharmaceuticals · NCT06990867

This study is testing if a new treatment called JX10 can help people who have had an acute ischemic stroke feel better and recover more functionally compared to a placebo.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment740 (estimated)
Ages18 Years to 90 Years
SexAll
SponsorCorxel Pharmaceuticals Industry-sponsored
Locations83 sites (Long Beach, California and 82 other locations)
Trial IDNCT06990867 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of JX10 compared to a placebo in patients with acute ischemic stroke who seek treatment within 4.5 to 24 hours of symptom onset. Participants will be randomly assigned to receive either JX10 at varying doses or a placebo in two parts, with the primary focus on improving functional outcomes as measured by the modified Rankin Scale. Additionally, the study will assess the risk of symptomatic intracranial hemorrhage associated with JX10 treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 who have experienced an acute ischemic stroke with specific occlusion characteristics and evidence of salvageable brain tissue.

Not a fit: Patients with large core infarctions, significant mass effects, or other contraindications to treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients suffering from acute ischemic stroke.

How similar studies have performed: Previous studies have shown promise in using reperfusion strategies for acute ischemic stroke, but the specific approach with JX10 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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. 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.

Where this trial is running

Long Beach, California and 82 other locations

+33 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Ischemic StrokereperfusionORIONLate PresentationJX10thrombolytic
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.