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 reclutamientoAdmite participantes ahora, según el registro.

Contactar con este estudio

En resumen

Fase 2 / Fase 3740 participantes buscados83 centros18 países

Categorías

Cardiovascular60%Neurología40%

Registrado en 1 registro

ClinicalTrials.govNCT06990867Abrir este registro en ClinicalTrials.govSincronizado hace 2 meses

Un mismo estudio puede estar registrado en varios registros. Lo mostramos una sola vez y enlazamos con todos los registros que tenemos.

La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

¿Le interesa este estudio?

Iniciar sesión o cree una cuenta para registrar su interés y seguir este estudio.

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.

Resumen

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.

Afecciones

Acute Ischemic Stroke

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	18 Years – 90 Years
Voluntarios sanos	No

Elegibilidad tal como figura en el registro

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.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudio	De intervención
Fase	Fase 2 / Fase 3
Asignación	Aleatorizado
Modelo de intervención	PARALLEL
Propósito principal	TREATMENT
Enmascaramiento	QUADRUPLE (4)
Inscripción	740 participantes buscados

Patrocinador y colaboradores

Corxel Pharmaceuticals Patrocinador

Grupos e intervenciones

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

Intervenciones

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

Variables de resultado

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

Fechas

Fechas
Fecha de inicio	15 de mayo de 2025 (real)
Finalización principal	31 de octubre de 2029 (estimada)
Finalización	31 de diciembre de 2029 (estimada)
Primera publicación	25 de mayo de 2025 (real)
Última actualización	13 de marzo de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	octubre de 2025

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

83 centros están en reclutamiento

Belgium

Belgium
Centro	Ciudad	Estado o región	Estado
Corxel Investigational Site	Ghent		En reclutamiento

Bulgaria

Bulgaria
Centro	Ciudad	Estado
Corxel Investigational Site	Blagoevgrad	En reclutamiento
Corxel Investigational Site	Burgas	En reclutamiento
Corxel Investigational Site	Pleven	En reclutamiento
Corxel Investigational Site	Plovdiv	En reclutamiento
Corxel Investigational Site	Sofia	En reclutamiento

Canada

Canada
Centro	Ciudad	Estado o región	Estado
Corxel Investigational Site	Edmonton		En reclutamiento
Corxel Investigational Site	Kingston		En reclutamiento

China

China
Centro	Ciudad	Estado
Corxel Investigational Site	Baotou	En reclutamiento
Corxel Investigational Site	Beijing	En reclutamiento
Corxel Investigational Site	Beijing	En reclutamiento
Corxel Investigational Site	Changchun	En reclutamiento
Corxel Investigational Site	Guangzhou	En reclutamiento
Corxel Investigational Site	Harbin	En reclutamiento
Corxel Investigational Site,	Harbin	En reclutamiento
Corxel Investigational Site	Kaili	En reclutamiento
Corxel Investigational Site	Linfen	En reclutamiento
Corxel Investigational Site	Shanghai	En reclutamiento
Corxel Investigational Site	Shenyang	En reclutamiento
Corxel Investigational Site	Suzhou	En reclutamiento
Corxel Investigational Site	Weifang	En reclutamiento
Corxel Investigational Site	Xuzhou	En reclutamiento

France

France
Centro	Ciudad	Estado o región	Estado
Corxel Investigational site	Lille		En reclutamiento
Corxel Investigational site	Paris		En reclutamiento

Germany

Germany
Centro	Ciudad	Estado
Corxel Investigational Site	Altenburg	En reclutamiento
Corxel Investigational Site	Leipzig	En reclutamiento
Corxel Investigational Site	Lübeck	En reclutamiento
Corxel Investigational Site	Trier	En reclutamiento

Greece

Greece
Centro	Ciudad	Estado
Corxel Investigational Site	Athens	En reclutamiento
Corxel Investigational Site	Chaïdári	En reclutamiento
Corxel Investigational Site	Pátrai	En reclutamiento
Corxel Investigational Site	Thessaloniki	En reclutamiento

Italy

Italy
Centro	Ciudad	Estado o región	Estado
Corxel Investigational Site	Pavia		En reclutamiento
Corxel Investigational Site	Roma		En reclutamiento

Japan

Japan
Centro	Ciudad	Estado
Corxel Investigational Site	Fukuoka	En reclutamiento
Corxel Investigational Site	Hyōgo	En reclutamiento
Corxel Investigational site	Ibaraki	En reclutamiento
Corxel Investigational Site	Kamakura	En reclutamiento
Corxel Investigational Site	Meguro City	En reclutamiento
Corxel Investigational Site	Mitaka	En reclutamiento
Corxel Investigational Site	Miyagi	En reclutamiento
Corxel Investigational site	Toyota	En reclutamiento
Corxel Investigational Site	Yamagata	En reclutamiento
Corxel Investigational Site	Yamaguchi	En reclutamiento

Latvia

Latvia
Centro	Ciudad	Estado o región	Estado
Corxel Investigational Site	Daugavpils		En reclutamiento
Corxel Investigational Site	Riga		En reclutamiento

Lithuania

Lithuania
Centro	Ciudad	Estado o región	Estado
Corxel Investigational Site	Kaunas		En reclutamiento
Corxel Investigational Site	Vilnius		En reclutamiento

Malaysia

Malaysia
Centro	Ciudad	Estado o región	Estado
Corxel Investigational Site	Kuching		En reclutamiento

Portugal

Portugal
Centro	Ciudad	Estado o región	Estado
Corxel Investigational Site	Braga		En reclutamiento

En el registro figuran 33 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

No se han registrado cambios desde que incorporamos este registro por primera vez.

Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.

Registro: ClinicalTrials.gov · NCT########

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