ClinicalTrials.gg
RecruitingNCT06990867ORIONUpdated Sep 21, 2026

Optimizing Reperfusion to Improve Outcomes and Neurologic Function

A Phase 2/3 interventional study of JX10 and Placebo in Acute Ischemic Stroke, sponsored by Corxel Pharmaceuticals. Recruiting at 104 sites in 21 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Corxel Pharmaceuticals · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started May 2025; still recruiting 1 year 5 months later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
740
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Ischemic Stroke

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Keywords

  • reperfusion
  • ORION
  • Acute Ischemic Stroke
  • Late Presentation
  • JX10
  • thrombolytic
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 740 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Corxel Pharmaceuticals is the lead sponsor of 12 studies on the registry; 2 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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, count \< 100,000/μL, > 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
740 participants (estimated)

Study arms

  • Experimental
    Part 1 - JX10 (1mg/kg)

    Drug: JX10

  • Experimental
    Part 1 - JX10 (3mg/kg)

    Drug: JX10

  • Placebo comparator
    Part 1 - Placebo

    Drug: Placebo

  • Experimental
    JX10 Part 2 - (1 or 3 mg/kg)

    Drug: JX10

  • Placebo comparator
    Part 2 - Placebo

    Drug: Placebo

Interventions

  • DrugJX10

    JX10 is a thrombolytic agent.

  • DrugPlacebo

    Placebo is being used as the comparator.

06

What researchers measure

Primary outcomes

  1. Efficacy: Proportion of participants with no or minimal symptoms (mRS score 0-1) at 90 days

    Time frame: 90 days

  2. Safety: Incidence of symptomatic intracranial hemorrhage within 36 hours post-randomization

    Time frame: Within 36 hours post-randomization

Secondary outcomes

  1. Ordinal mRS score (0-6), based on a 6-point ordinal scale at 90 days

    Time frame: 90 days

  2. Proportion of participants with functional independence at 90 days

    Functional independence: mRS score 0-2

    Time frame: 90 days

  3. Incidence of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: 90 days

  4. Incidence of major bleeding within 24 hours and 14 days of study treatment

    Time frame: Within 24 hours and 14 days of study treatment

07

Study locations

104 of 104 sites recruiting
  • Corxel Investigational Site
    Long Beach, California 90806, United States
    Recruiting
  • Corxel Investigational Site
    Los Angeles, California 90048, United States
    Recruiting
  • Corxel Investigational Site
    Sacramento, California 95817, United States
    Recruiting
  • Corxel Investigational Site
    Colorado Springs, Colorado 80909, United States
    Recruiting
  • Corxel Investigational Site
    Washington D.C., District of Columbia 20007, United States
    Recruiting
  • Corxel Investigational Site
    Delray Beach, Florida 33484, United States
    Recruiting
  • Corxel Investigational Site
    Chicago, Illinois 60616, United States
    Recruiting
    • Study Director · Contact
  • Corxel Investigational Site
    Wichita, Kansas 67214, United States
    Recruiting
  • Corxel Investigational Site
    Baltimore, Maryland 21215, United States
    Recruiting
  • Corxel Investigational Site
    Kalamazoo, Michigan 49048, United States
    Recruiting
  • Corxel Investigational Site
    Traverse City, Michigan 49684, United States
    Recruiting
  • Corxel Investigational Site
    St Louis, Missouri 63110, United States
    Recruiting
  • Corxel Investigational Site
    Great Neck, New York 11021, United States
    Recruiting
  • Corxel Investigational Site
    New York, New York 10029, United States
    Recruiting
  • Corxel Investigational Site
    Columbus, Ohio 43214, United States
    Recruiting
  • Corxel Investigational Site
    Toledo, Ohio 43606, United States
    Recruiting
  • Corxel Investigational Site
    Tulsa, Oklahoma 74104, United States
    Recruiting
  • Corxel Investigational Site
    Chattanooga, Tennessee 37404, United States
    Recruiting
  • Corxel Investigational Site
    Dallas, Texas 75246, United States
    Recruiting
  • Corxel Investigational Site
    Houston, Texas 77030, United States
    Recruiting
  • Corxel Investigational Site
    Ghent, 9000, Belgium
    Recruiting
  • Corxel Investigational Site
    Hasselt, Belgium
    Recruiting
  • Corxel Investigational Site
    Blagoevgrad, Bulgaria
    Recruiting
  • Corxel Investigational Site
    Burgas, Bulgaria
    Recruiting
  • Corxel Investigational Site
    Pleven, Bulgaria
    Recruiting
  • Corxel Investigational Site
    Plovdiv, Bulgaria
    Recruiting
  • Corxel Investigational Site
    Sofia, 1606, Bulgaria
    Recruiting
  • Corxel Investigational Site
    Edmonton, Canada
    Recruiting
  • Corxel Investigational Site
    Kingston, Canada
    Recruiting
  • Corxel Investigational Site
    Winnipeg, Canada
    Recruiting
  • Corxel Investigational Site
    Baotou, China
    Recruiting
  • Corxel Investigational Site
    Beijing, China
    Recruiting
    • Study Director · Contact
  • Corxel Investigational Site
    Beijing, China
    Recruiting
  • Corxel Investigational Site
    Changchun, China
    Recruiting
  • Corxel Investigational Site
    Guangzhou, China
    Recruiting
  • Corxel Investigational Site,
    Harbin, China
    Recruiting
  • Corxel Investigational Site
    Harbin, China
    Recruiting
  • Corxel Investigational Site
    Kaili, China
    Recruiting
  • Corxel Investigational Site
    Linfen, China
    Recruiting
  • Corxel Investigational Site
    Nanyang, China
    Recruiting
  • Corxel Investigational Site
    Shanghai, China
    Recruiting
  • Corxel Investigational Site
    Shenyang, China
    Recruiting
  • Corxel Investigational Site
    Suzhou, China
    Recruiting
  • Corxel Investigational Site
    Weifang, China
    Recruiting
  • Corxel Investigational Site
    Xuzhou, China
    Recruiting
  • Corxel Investigational Site
    Zhangjiakou, China
    Recruiting
  • Corxel Investigational site
    Lille, France
    Recruiting
  • Corxel Investigational Site
    Nancy, France
    Recruiting
  • Corxel Investigational site
    Paris, France
    Recruiting
  • Corxel Investigational Site
    Rouen, France
    Recruiting
  • Corxel Investigational Site
    Toulouse, France
    Recruiting
  • Corxel Investigational Site
    Tours, France
    Recruiting
  • Corxel Investigational Site
    Altenburg, Germany
    Recruiting
  • Corxel Investigational Site
    Frankfurt, Germany
    Recruiting
  • Corxel Investigational Site
    Leipzig, Germany
    Recruiting
  • Corxel Investigational Site
    Lübeck, Germany
    Recruiting
  • Corxel Investigational Site
    Trier, Germany
    Recruiting
  • Corxel Investigational Site
    Athens, Greece
    Recruiting
  • Corxel Investigational Site
    Chaïdári, Greece
    Recruiting
  • Corxel Investigational Site
    Pátrai, Greece
    Recruiting
  • Corxel Investigational Site
    Thessaloniki, Greece
    Recruiting
  • Corxel Investigational Site
    Budapest, Hungary
    Recruiting
  • Corxel Investigational Site
    Pavia, Italy
    Recruiting
  • Corxel Investigational Site
    Roma, Italy
    Recruiting
  • Corxel Investigational Site
    Fukuoka, Japan
    Recruiting
  • Corxel Investigational Site
    Hyōgo, Japan
    Recruiting
  • Corxel Investigational site
    Ibaraki, Japan
    Recruiting
  • Corxel Investigational Site
    Kamakura, Japan
    Recruiting
  • Corxel Investigational Site
    Meguro City, Japan
    Recruiting
  • Corxel Investigational Site
    Mitaka, Japan
    Recruiting
  • Corxel Investigational Site
    Miyagi, Japan
    Recruiting
  • Corxel Investigational site
    Toyota, Japan
    Recruiting
  • Corxel Investigational Site
    Yamagata, Japan
    Recruiting
  • Corxel Investigational Site
    Yamaguchi, Japan
    Recruiting
  • Corxel Investigational Site
    Daugavpils, Latvia
    Recruiting
  • Corxel Investigational Site
    Riga, Latvia
    Recruiting
  • Corxel Investigational Site
    Kaunas, Lithuania
    Recruiting
  • Corxel Investigational Site
    Vilnius, Lithuania
    Recruiting
  • Corxel Investigational Site
    Kuching, Malaysia
    Recruiting
  • Corxel Investigational Site
    Almada, Portugal
    Recruiting
  • Corxel Investigational Site
    Braga, Portugal
    Recruiting
  • Corxel Investigational Site
    Faro, Portugal
    Recruiting
  • Corxel Investigational Site
    Loures, Portugal
    Recruiting
  • Corxel Investigational Site
    Matosinhos Municipality, Portugal
    Recruiting
  • Corxel Investigational Site
    Belgrade, Serbia
    Recruiting
  • Corxel Investigational Site
    Kragujevac, Serbia
    Recruiting
  • Corxel Investigational Site
    Niš, Serbia
    Recruiting
  • Corxel Investigational Site
    Novi Sad, Serbia
    Recruiting
  • Corxel Investigational Site
    Seoul, South Korea
    Recruiting
  • Corxel Investigational Site
    A Coruña, Spain
    Recruiting
  • Corxel Investigational Site
    Albacete, Spain
    Recruiting
  • Corxel Investigational Site
    Barcelona, Spain
    Recruiting
  • Corxel Investigational Site
    Girona, Spain
    Recruiting
  • Corxel Investigational Site
    Madrid, Spain
    Recruiting
  • Corxel Investigational Site
    Madrid, Spain
    Recruiting
  • Corxel Investigational Site
    Málaga, Spain
    Recruiting
  • Corxel Investigational Site
    Seville, Spain
    Recruiting
  • Corxel Investigational Site
    Valencia, Spain
    Recruiting
  • Corxel Investigational Site
    Bangkok, Thailand
    Recruiting
  • Corxel Investigational Site
    Khon Kaen, Thailand
    Recruiting

Showing the first 100 of 104 sites across 21 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06990867
Lead sponsor
Corxel Pharmaceuticals
Responsible party
Sponsor
First posted
May 25, 2025
Start date
May 15, 2025
Primary completion
Oct 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Sep 21, 2026

Study contacts

Corxel Pharmaceuticals Study Information Center
Contact
Information.center@corxelbio.com
201-268-3723
Senior Director, Clinical Operations
study director · Corxel Pharmaceuticals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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