xMedica

NCT06990867ClinicalTrials.gov

Optimizing Reperfusion to Improve Outcomes and Neurologic Function

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

RecruitingTaking participants now, according to the registry record.
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In brief

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…

Phase 2 / Phase 3740 participants sought83 sites18 countries

Categories

Cardiovascular60%Neurology40%

Registered in 1 registry

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered after enrolment began (about 10 days after the recorded start)First posted 2025-05-25; recorded start 2025-05-15
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 6 other studies in this databaseCounted from the lead sponsor named in the record (Corxel Pharmaceuticals)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding20/20

    Quadruple-blind

  • Control arm13/15

    Placebo / sham control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 83 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration3/5

    Registered within 30 days of the study start

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 740 participants (target), run at 83 sites, across 18 countries.

How this score is built
  • Enrolment28/40

    740 participants (target)

  • Site count22/25

    83 sites

  • Country count15/15

    18 countries

  • Planned duration10/10

    Planned over about 56 months

  • Sponsor scale3/10

    Corxel Pharmaceuticals has led 7 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

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.

Conditions

  • Acute Ischemic Stroke

Eligibility

SexAll
Ages18 Years – 90 Years
Healthy volunteersNo

Eligibility as written in the registry

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.

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study typeInterventional
PhasePhase 2 / Phase 3
AllocationRandomised
Intervention modelPARALLEL
Primary purposeTREATMENT
MaskingQUADRUPLE (4)
Enrolment740 participants sought

Sponsor and collaborators

  • Corxel Pharmaceuticals Sponsor

Arms and interventions

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

Interventions

  • Drug JX10

    JX10 is a thrombolytic agent.

  • Drug Placebo

    Placebo is being used as the comparator.

Outcome measures

  1. Primary outcome

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

    Time frame 90 days

  2. Primary outcome

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

    Time frame Within 36 hours post-randomization

  3. Secondary outcome

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

    Time frame Within 24 hours and 14 days of study treatment

  4. Secondary outcome

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

    Time frame 90 days

  5. Secondary outcome

    Proportion of participants with functional independence at 90 days

    Functional independence: mRS score 0-2

    Time frame 90 days

  6. Secondary outcome

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

    Time frame 90 days

Dates

Start dateMay 15, 2025 (actual)
Primary completionOctober 31, 2029 (estimated)
CompletionDecember 31, 2029 (estimated)
First postedMay 25, 2025 (actual)
Last updatedMarch 13, 2026
Results postedNot stated in the registry record
Status last verifiedOctober 2025

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

83 sites are recruiting

Belgium

FacilityCityState or regionStatus
Corxel Investigational SiteGhentRecruiting

Bulgaria

FacilityCityState or regionStatus
Corxel Investigational SiteBlagoevgradRecruiting
Corxel Investigational SiteBurgasRecruiting
Corxel Investigational SitePlevenRecruiting
Corxel Investigational SitePlovdivRecruiting
Corxel Investigational SiteSofiaRecruiting

Canada

FacilityCityState or regionStatus
Corxel Investigational SiteEdmontonRecruiting
Corxel Investigational SiteKingstonRecruiting

China

FacilityCityState or regionStatus
Corxel Investigational SiteBaotouRecruiting
Corxel Investigational SiteBeijingRecruiting
Corxel Investigational SiteBeijingRecruiting
Corxel Investigational SiteChangchunRecruiting
Corxel Investigational SiteGuangzhouRecruiting
Corxel Investigational SiteHarbinRecruiting
Corxel Investigational Site,HarbinRecruiting
Corxel Investigational SiteKailiRecruiting
Corxel Investigational SiteLinfenRecruiting
Corxel Investigational SiteShanghaiRecruiting
Corxel Investigational SiteShenyangRecruiting
Corxel Investigational SiteSuzhouRecruiting
Corxel Investigational SiteWeifangRecruiting
Corxel Investigational SiteXuzhouRecruiting

France

FacilityCityState or regionStatus
Corxel Investigational siteLilleRecruiting
Corxel Investigational siteParisRecruiting

Germany

FacilityCityState or regionStatus
Corxel Investigational SiteAltenburgRecruiting
Corxel Investigational SiteLeipzigRecruiting
Corxel Investigational SiteLübeckRecruiting
Corxel Investigational SiteTrierRecruiting

Greece

FacilityCityState or regionStatus
Corxel Investigational SiteAthensRecruiting
Corxel Investigational SiteChaïdáriRecruiting
Corxel Investigational SitePátraiRecruiting
Corxel Investigational SiteThessalonikiRecruiting

Italy

FacilityCityState or regionStatus
Corxel Investigational SitePaviaRecruiting
Corxel Investigational SiteRomaRecruiting

Japan

FacilityCityState or regionStatus
Corxel Investigational SiteFukuokaRecruiting
Corxel Investigational SiteHyōgoRecruiting
Corxel Investigational siteIbarakiRecruiting
Corxel Investigational SiteKamakuraRecruiting
Corxel Investigational SiteMeguro CityRecruiting
Corxel Investigational SiteMitakaRecruiting
Corxel Investigational SiteMiyagiRecruiting
Corxel Investigational siteToyotaRecruiting
Corxel Investigational SiteYamagataRecruiting
Corxel Investigational SiteYamaguchiRecruiting

Latvia

FacilityCityState or regionStatus
Corxel Investigational SiteDaugavpilsRecruiting
Corxel Investigational SiteRigaRecruiting

Lithuania

FacilityCityState or regionStatus
Corxel Investigational SiteKaunasRecruiting
Corxel Investigational SiteVilniusRecruiting

Malaysia

FacilityCityState or regionStatus
Corxel Investigational SiteKuchingRecruiting

Portugal

FacilityCityState or regionStatus
Corxel Investigational SiteBragaRecruiting

33 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

No changes have been recorded since we first ingested this record.

A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06990867