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

En recrutementAccepte des participants actuellement, selon la fiche du registre.

Contacter cette étude

En bref

Phase 2 / Phase 3740 participants recherchés83 sites18 pays

Catégories

Cardiovasculaire60%Neurologie40%

Enregistré dans 1 registre

ClinicalTrials.govNCT06990867Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 2 mois

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Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Not stated: Registered after enrolment began (about 10 days after the recorded start)First posted 2025-05-25; recorded start 2025-05-15
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: 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.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 6 other studies in this databaseCounted from the lead sponsor named in the record (Corxel Pharmaceuticals)
Not stated: 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.

Résumé

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.

Affections

Acute Ischemic Stroke

Éligibilité

Éligibilité
Sexe	Tous
Âges	18 Years – 90 Years
Volontaires sains	Non

Éligibilité telle qu'elle figure dans le registre

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.

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étude	Interventionnelle
Phase	Phase 2 / Phase 3
Répartition	Randomisée
Modèle d'intervention	PARALLEL
Objectif principal	TREATMENT
Insu	QUADRUPLE (4)
Recrutement	740 participants recherchés

Promoteur et collaborateurs

Corxel Pharmaceuticals Promoteur

Groupes et 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

Médicament JX10
JX10 is a thrombolytic agent.
Médicament Placebo
Placebo is being used as the comparator.

Critères de jugement

Critère de jugement principal
Efficacy: Proportion of participants with no or minimal symptoms (mRS score 0-1) at 90 days
Délai 90 days
Critère de jugement principal
Safety: Incidence of symptomatic intracranial hemorrhage within 36 hours post-randomization
Délai Within 36 hours post-randomization
Critère de jugement secondaire
Incidence of major bleeding within 24 hours and 14 days of study treatment
Délai Within 24 hours and 14 days of study treatment
Critère de jugement secondaire
Ordinal mRS score (0-6), based on a 6-point ordinal scale at 90 days
Délai 90 days
Critère de jugement secondaire
Proportion of participants with functional independence at 90 days
Functional independence: mRS score 0-2
Délai 90 days
Critère de jugement secondaire
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Délai 90 days

Dates

Dates
Date de début	15 mai 2025 (réelle)
Achèvement principal	31 octobre 2029 (estimée)
Achèvement	31 décembre 2029 (estimée)
Première publication	25 mai 2025 (réelle)
Dernière mise à jour	13 mars 2026
Résultats publiés	Non précisé dans la fiche du registre
Statut vérifié pour la dernière fois	octobre 2025

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

83 sites sont en recrutement

Belgium

Belgium
Établissement	Ville	État ou région	Statut
Corxel Investigational Site	Ghent		En recrutement

Bulgaria

Bulgaria
Établissement	Ville	Statut
Corxel Investigational Site	Blagoevgrad	En recrutement
Corxel Investigational Site	Burgas	En recrutement
Corxel Investigational Site	Pleven	En recrutement
Corxel Investigational Site	Plovdiv	En recrutement
Corxel Investigational Site	Sofia	En recrutement

Canada

Canada
Établissement	Ville	État ou région	Statut
Corxel Investigational Site	Edmonton		En recrutement
Corxel Investigational Site	Kingston		En recrutement

China

China
Établissement	Ville	Statut
Corxel Investigational Site	Baotou	En recrutement
Corxel Investigational Site	Beijing	En recrutement
Corxel Investigational Site	Beijing	En recrutement
Corxel Investigational Site	Changchun	En recrutement
Corxel Investigational Site	Guangzhou	En recrutement
Corxel Investigational Site	Harbin	En recrutement
Corxel Investigational Site,	Harbin	En recrutement
Corxel Investigational Site	Kaili	En recrutement
Corxel Investigational Site	Linfen	En recrutement
Corxel Investigational Site	Shanghai	En recrutement
Corxel Investigational Site	Shenyang	En recrutement
Corxel Investigational Site	Suzhou	En recrutement
Corxel Investigational Site	Weifang	En recrutement
Corxel Investigational Site	Xuzhou	En recrutement

France

France
Établissement	Ville	État ou région	Statut
Corxel Investigational site	Lille		En recrutement
Corxel Investigational site	Paris		En recrutement

Germany

Germany
Établissement	Ville	Statut
Corxel Investigational Site	Altenburg	En recrutement
Corxel Investigational Site	Leipzig	En recrutement
Corxel Investigational Site	Lübeck	En recrutement
Corxel Investigational Site	Trier	En recrutement

Greece

Greece
Établissement	Ville	Statut
Corxel Investigational Site	Athens	En recrutement
Corxel Investigational Site	Chaïdári	En recrutement
Corxel Investigational Site	Pátrai	En recrutement
Corxel Investigational Site	Thessaloniki	En recrutement

Italy

Italy
Établissement	Ville	État ou région	Statut
Corxel Investigational Site	Pavia		En recrutement
Corxel Investigational Site	Roma		En recrutement

Japan

Japan
Établissement	Ville	Statut
Corxel Investigational Site	Fukuoka	En recrutement
Corxel Investigational Site	Hyōgo	En recrutement
Corxel Investigational site	Ibaraki	En recrutement
Corxel Investigational Site	Kamakura	En recrutement
Corxel Investigational Site	Meguro City	En recrutement
Corxel Investigational Site	Mitaka	En recrutement
Corxel Investigational Site	Miyagi	En recrutement
Corxel Investigational site	Toyota	En recrutement
Corxel Investigational Site	Yamagata	En recrutement
Corxel Investigational Site	Yamaguchi	En recrutement

Latvia

Latvia
Établissement	Ville	État ou région	Statut
Corxel Investigational Site	Daugavpils		En recrutement
Corxel Investigational Site	Riga		En recrutement

Lithuania

Lithuania
Établissement	Ville	État ou région	Statut
Corxel Investigational Site	Kaunas		En recrutement
Corxel Investigational Site	Vilnius		En recrutement

Malaysia

Malaysia
Établissement	Ville	État ou région	Statut
Corxel Investigational Site	Kuching		En recrutement

Portugal

Portugal
Établissement	Ville	État ou région	Statut
Corxel Investigational Site	Braga		En recrutement

33 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

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