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

RekrutiertNimmt laut Registereintrag derzeit Teilnehmende auf.
Diese Studie kontaktieren

Kurz gefasst

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 Teilnehmende gesucht83 Studienzentren18 Länder

Kategorien

Herz-Kreislauf60%Neurologie40%

In 1 Register registriert

Eine Studie kann in mehreren Registern registriert sein. Wir zeigen sie einmal und verlinken jeden Eintrag, den wir haben.

Die Studieninformationen werden so angezeigt, wie sie vom Register veröffentlicht wurden, in ihrer Originalsprache.

Interesse an dieser Studie?

Anmelden oder ein Konto erstellen um Ihr Interesse zu bekunden und diese Studie zu verfolgen.

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.

Zusammenfassung

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.

Erkrankungen

  • Acute Ischemic Stroke

Eignung

GeschlechtAlle
Alter18 Years – 90 Years
Gesunde FreiwilligeNein

Eignung im Wortlaut des Registers

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.

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

StudientypInterventionell
PhasePhase 2 / Phase 3
ZuteilungRandomisiert
InterventionsmodellPARALLEL
Primäres ZielTREATMENT
VerblindungQUADRUPLE (4)
Teilnahme740 Teilnehmende gesucht

Sponsor und Mitwirkende

  • Corxel Pharmaceuticals Sponsor

Studienarme und Interventionen

  • 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

Interventionen

  • Arzneimittel JX10

    JX10 is a thrombolytic agent.

  • Arzneimittel Placebo

    Placebo is being used as the comparator.

Endpunkte

  1. Primärer Endpunkt

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

    Zeitrahmen 90 days

  2. Primärer Endpunkt

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

    Zeitrahmen Within 36 hours post-randomization

  3. Sekundärer Endpunkt

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

    Zeitrahmen Within 24 hours and 14 days of study treatment

  4. Sekundärer Endpunkt

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

    Zeitrahmen 90 days

  5. Sekundärer Endpunkt

    Proportion of participants with functional independence at 90 days

    Functional independence: mRS score 0-2

    Zeitrahmen 90 days

  6. Sekundärer Endpunkt

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

    Zeitrahmen 90 days

Daten

Startdatum15. Mai 2025 (tatsächlich)
Primärer Abschluss31. Oktober 2029 (geschätzt)
Abschluss31. Dezember 2029 (geschätzt)
Erstveröffentlichung25. Mai 2025 (tatsächlich)
Zuletzt aktualisiert13. März 2026
Ergebnisse veröffentlichtIm Registereintrag nicht angegeben
Status zuletzt bestätigtOktober 2025

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

83 Studienzentren rekrutieren

Belgium

EinrichtungStadtBundesland oder RegionStatus
Corxel Investigational SiteGhentRekrutiert

Bulgaria

EinrichtungStadtBundesland oder RegionStatus
Corxel Investigational SiteBlagoevgradRekrutiert
Corxel Investigational SiteBurgasRekrutiert
Corxel Investigational SitePlevenRekrutiert
Corxel Investigational SitePlovdivRekrutiert
Corxel Investigational SiteSofiaRekrutiert

Canada

EinrichtungStadtBundesland oder RegionStatus
Corxel Investigational SiteEdmontonRekrutiert
Corxel Investigational SiteKingstonRekrutiert

China

EinrichtungStadtBundesland oder RegionStatus
Corxel Investigational SiteBaotouRekrutiert
Corxel Investigational SiteBeijingRekrutiert
Corxel Investigational SiteBeijingRekrutiert
Corxel Investigational SiteChangchunRekrutiert
Corxel Investigational SiteGuangzhouRekrutiert
Corxel Investigational SiteHarbinRekrutiert
Corxel Investigational Site,HarbinRekrutiert
Corxel Investigational SiteKailiRekrutiert
Corxel Investigational SiteLinfenRekrutiert
Corxel Investigational SiteShanghaiRekrutiert
Corxel Investigational SiteShenyangRekrutiert
Corxel Investigational SiteSuzhouRekrutiert
Corxel Investigational SiteWeifangRekrutiert
Corxel Investigational SiteXuzhouRekrutiert

France

EinrichtungStadtBundesland oder RegionStatus
Corxel Investigational siteLilleRekrutiert
Corxel Investigational siteParisRekrutiert

Germany

EinrichtungStadtBundesland oder RegionStatus
Corxel Investigational SiteAltenburgRekrutiert
Corxel Investigational SiteLeipzigRekrutiert
Corxel Investigational SiteLübeckRekrutiert
Corxel Investigational SiteTrierRekrutiert

Greece

EinrichtungStadtBundesland oder RegionStatus
Corxel Investigational SiteAthensRekrutiert
Corxel Investigational SiteChaïdáriRekrutiert
Corxel Investigational SitePátraiRekrutiert
Corxel Investigational SiteThessalonikiRekrutiert

Italy

EinrichtungStadtBundesland oder RegionStatus
Corxel Investigational SitePaviaRekrutiert
Corxel Investigational SiteRomaRekrutiert

Japan

EinrichtungStadtBundesland oder RegionStatus
Corxel Investigational SiteFukuokaRekrutiert
Corxel Investigational SiteHyōgoRekrutiert
Corxel Investigational siteIbarakiRekrutiert
Corxel Investigational SiteKamakuraRekrutiert
Corxel Investigational SiteMeguro CityRekrutiert
Corxel Investigational SiteMitakaRekrutiert
Corxel Investigational SiteMiyagiRekrutiert
Corxel Investigational siteToyotaRekrutiert
Corxel Investigational SiteYamagataRekrutiert
Corxel Investigational SiteYamaguchiRekrutiert

Latvia

EinrichtungStadtBundesland oder RegionStatus
Corxel Investigational SiteDaugavpilsRekrutiert
Corxel Investigational SiteRigaRekrutiert

Lithuania

EinrichtungStadtBundesland oder RegionStatus
Corxel Investigational SiteKaunasRekrutiert
Corxel Investigational SiteVilniusRekrutiert

Malaysia

EinrichtungStadtBundesland oder RegionStatus
Corxel Investigational SiteKuchingRekrutiert

Portugal

EinrichtungStadtBundesland oder RegionStatus
Corxel Investigational SiteBragaRekrutiert

33 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

Register: ClinicalTrials.gov · NCT########

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