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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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…

المرحلة 2 / المرحلة 3مطلوب 740 مشاركاً83 موقعاً18 دولة

الفئات

القلب والأوعية الدموية60%طب الأعصاب40%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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.

ملخص

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.

الحالات

  • Acute Ischemic Stroke

الأهلية

الجنسالجميع
الأعمار18 Years – 90 Years
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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.

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 2 / المرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةQUADRUPLE (4)
التجنيدمطلوب 740 مشاركاً

الجهة الراعية والمتعاونون

  • Corxel Pharmaceuticals الجهة الراعية

الأذرع والتدخلات

  • 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

التدخلات

  • دواء JX10

    JX10 is a thrombolytic agent.

  • دواء Placebo

    Placebo is being used as the comparator.

مقاييس النتائج

  1. مقياس النتيجة الأولي

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

    الإطار الزمني 90 days

  2. مقياس النتيجة الأولي

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

    الإطار الزمني Within 36 hours post-randomization

  3. مقياس النتيجة الثانوي

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

    الإطار الزمني Within 24 hours and 14 days of study treatment

  4. مقياس النتيجة الثانوي

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

    الإطار الزمني 90 days

  5. مقياس النتيجة الثانوي

    Proportion of participants with functional independence at 90 days

    Functional independence: mRS score 0-2

    الإطار الزمني 90 days

  6. مقياس النتيجة الثانوي

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

    الإطار الزمني 90 days

التواريخ

تاريخ البدء15 مايو 2025 (فعلي)
الإتمام الأولي31 أكتوبر 2029 (تقديري)
الإتمام31 ديسمبر 2029 (تقديري)
أول نشر25 مايو 2025 (فعلي)
آخر تحديث13 مارس 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةأكتوبر 2025

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

83 موقعاً قيد التجنيد

Belgium

المنشأةالمدينةالولاية أو المنطقةالحالة
Corxel Investigational SiteGhentقيد التجنيد

Bulgaria

المنشأةالمدينةالولاية أو المنطقةالحالة
Corxel Investigational SiteBlagoevgradقيد التجنيد
Corxel Investigational SiteBurgasقيد التجنيد
Corxel Investigational SitePlevenقيد التجنيد
Corxel Investigational SitePlovdivقيد التجنيد
Corxel Investigational SiteSofiaقيد التجنيد

Canada

المنشأةالمدينةالولاية أو المنطقةالحالة
Corxel Investigational SiteEdmontonقيد التجنيد
Corxel Investigational SiteKingstonقيد التجنيد

China

المنشأةالمدينةالولاية أو المنطقةالحالة
Corxel Investigational SiteBaotouقيد التجنيد
Corxel Investigational SiteBeijingقيد التجنيد
Corxel Investigational SiteBeijingقيد التجنيد
Corxel Investigational SiteChangchunقيد التجنيد
Corxel Investigational SiteGuangzhouقيد التجنيد
Corxel Investigational SiteHarbinقيد التجنيد
Corxel Investigational Site,Harbinقيد التجنيد
Corxel Investigational SiteKailiقيد التجنيد
Corxel Investigational SiteLinfenقيد التجنيد
Corxel Investigational SiteShanghaiقيد التجنيد
Corxel Investigational SiteShenyangقيد التجنيد
Corxel Investigational SiteSuzhouقيد التجنيد
Corxel Investigational SiteWeifangقيد التجنيد
Corxel Investigational SiteXuzhouقيد التجنيد

France

المنشأةالمدينةالولاية أو المنطقةالحالة
Corxel Investigational siteLilleقيد التجنيد
Corxel Investigational siteParisقيد التجنيد

Germany

المنشأةالمدينةالولاية أو المنطقةالحالة
Corxel Investigational SiteAltenburgقيد التجنيد
Corxel Investigational SiteLeipzigقيد التجنيد
Corxel Investigational SiteLübeckقيد التجنيد
Corxel Investigational SiteTrierقيد التجنيد

Greece

المنشأةالمدينةالولاية أو المنطقةالحالة
Corxel Investigational SiteAthensقيد التجنيد
Corxel Investigational SiteChaïdáriقيد التجنيد
Corxel Investigational SitePátraiقيد التجنيد
Corxel Investigational SiteThessalonikiقيد التجنيد

Italy

المنشأةالمدينةالولاية أو المنطقةالحالة
Corxel Investigational SitePaviaقيد التجنيد
Corxel Investigational SiteRomaقيد التجنيد

Japan

المنشأةالمدينةالولاية أو المنطقةالحالة
Corxel Investigational SiteFukuokaقيد التجنيد
Corxel Investigational SiteHyōgoقيد التجنيد
Corxel Investigational siteIbarakiقيد التجنيد
Corxel Investigational SiteKamakuraقيد التجنيد
Corxel Investigational SiteMeguro Cityقيد التجنيد
Corxel Investigational SiteMitakaقيد التجنيد
Corxel Investigational SiteMiyagiقيد التجنيد
Corxel Investigational siteToyotaقيد التجنيد
Corxel Investigational SiteYamagataقيد التجنيد
Corxel Investigational SiteYamaguchiقيد التجنيد

Latvia

المنشأةالمدينةالولاية أو المنطقةالحالة
Corxel Investigational SiteDaugavpilsقيد التجنيد
Corxel Investigational SiteRigaقيد التجنيد

Lithuania

المنشأةالمدينةالولاية أو المنطقةالحالة
Corxel Investigational SiteKaunasقيد التجنيد
Corxel Investigational SiteVilniusقيد التجنيد

Malaysia

المنشأةالمدينةالولاية أو المنطقةالحالة
Corxel Investigational SiteKuchingقيد التجنيد

Portugal

المنشأةالمدينةالولاية أو المنطقةالحالة
Corxel Investigational SiteBragaقيد التجنيد

يُدرَج 33 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

السجل: ClinicalTrials.gov · NCT########

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