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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.

Contatta questo studio

In breve

Fase 2 / Fase 3740 partecipanti ricercati83 centri18 paesi

Categorie

Cardiovascolare60%Neurologia40%

Registrato in 1 registro

ClinicalTrials.govNCT06990867Apri questa scheda su ClinicalTrials.govSincronizzato 2 mesi fa

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Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

Sintesi

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.

Patologie

Acute Ischemic Stroke

Idoneità

Idoneità
Sesso	Tutti
Età	18 Years – 90 Years
Volontari sani	No

Idoneità come riportata nel 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.

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studio	Interventistico
Fase	Fase 2 / Fase 3
Assegnazione	Randomizzata
Modello di intervento	PARALLEL
Finalità principale	TREATMENT
Mascheramento	QUADRUPLE (4)
Arruolamento	740 partecipanti ricercati

Sponsor e collaboratori

Corxel Pharmaceuticals Sponsor

Bracci e interventi

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

Interventi

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

Esiti misurati

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

Date

Date
Data di inizio	15 maggio 2025 (effettiva)
Conclusione primaria	31 ottobre 2029 (stimata)
Conclusione	31 dicembre 2029 (stimata)
Prima pubblicazione	25 maggio 2025 (effettiva)
Ultimo aggiornamento	13 marzo 2026
Risultati pubblicati	Non indicato nella scheda del registro
Stato verificato l'ultima volta	ottobre 2025

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

83 centri stanno reclutando

Belgium

Belgium
Struttura	Città	Stato o regione	Stato
Corxel Investigational Site	Ghent		In reclutamento

Bulgaria

Bulgaria
Struttura	Città	Stato
Corxel Investigational Site	Blagoevgrad	In reclutamento
Corxel Investigational Site	Burgas	In reclutamento
Corxel Investigational Site	Pleven	In reclutamento
Corxel Investigational Site	Plovdiv	In reclutamento
Corxel Investigational Site	Sofia	In reclutamento

Canada

Canada
Struttura	Città	Stato o regione	Stato
Corxel Investigational Site	Edmonton		In reclutamento
Corxel Investigational Site	Kingston		In reclutamento

China

China
Struttura	Città	Stato
Corxel Investigational Site	Baotou	In reclutamento
Corxel Investigational Site	Beijing	In reclutamento
Corxel Investigational Site	Beijing	In reclutamento
Corxel Investigational Site	Changchun	In reclutamento
Corxel Investigational Site	Guangzhou	In reclutamento
Corxel Investigational Site	Harbin	In reclutamento
Corxel Investigational Site,	Harbin	In reclutamento
Corxel Investigational Site	Kaili	In reclutamento
Corxel Investigational Site	Linfen	In reclutamento
Corxel Investigational Site	Shanghai	In reclutamento
Corxel Investigational Site	Shenyang	In reclutamento
Corxel Investigational Site	Suzhou	In reclutamento
Corxel Investigational Site	Weifang	In reclutamento
Corxel Investigational Site	Xuzhou	In reclutamento

France

France
Struttura	Città	Stato o regione	Stato
Corxel Investigational site	Lille		In reclutamento
Corxel Investigational site	Paris		In reclutamento

Germany

Germany
Struttura	Città	Stato
Corxel Investigational Site	Altenburg	In reclutamento
Corxel Investigational Site	Leipzig	In reclutamento
Corxel Investigational Site	Lübeck	In reclutamento
Corxel Investigational Site	Trier	In reclutamento

Greece

Greece
Struttura	Città	Stato
Corxel Investigational Site	Athens	In reclutamento
Corxel Investigational Site	Chaïdári	In reclutamento
Corxel Investigational Site	Pátrai	In reclutamento
Corxel Investigational Site	Thessaloniki	In reclutamento

Italy

Italy
Struttura	Città	Stato o regione	Stato
Corxel Investigational Site	Pavia		In reclutamento
Corxel Investigational Site	Roma		In reclutamento

Japan

Japan
Struttura	Città	Stato
Corxel Investigational Site	Fukuoka	In reclutamento
Corxel Investigational Site	Hyōgo	In reclutamento
Corxel Investigational site	Ibaraki	In reclutamento
Corxel Investigational Site	Kamakura	In reclutamento
Corxel Investigational Site	Meguro City	In reclutamento
Corxel Investigational Site	Mitaka	In reclutamento
Corxel Investigational Site	Miyagi	In reclutamento
Corxel Investigational site	Toyota	In reclutamento
Corxel Investigational Site	Yamagata	In reclutamento
Corxel Investigational Site	Yamaguchi	In reclutamento

Latvia

Latvia
Struttura	Città	Stato o regione	Stato
Corxel Investigational Site	Daugavpils		In reclutamento
Corxel Investigational Site	Riga		In reclutamento

Lithuania

Lithuania
Struttura	Città	Stato o regione	Stato
Corxel Investigational Site	Kaunas		In reclutamento
Corxel Investigational Site	Vilnius		In reclutamento

Malaysia

Malaysia
Struttura	Città	Stato o regione	Stato
Corxel Investigational Site	Kuching		In reclutamento

Portugal

Portugal
Struttura	Città	Stato o regione	Stato
Corxel Investigational Site	Braga		In reclutamento

Nella scheda del registro sono indicati altri 33 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

Non è stata registrata alcuna modifica da quando abbiamo acquisito questa scheda.

Viene registrata una modifica ogni volta che lo sponsor aggiorna la scheda del registro. Stato, date, arruolamento e centri compaiono qui man mano che cambiano.

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

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