Recruiting NCT06990867

Optimizing Reperfusion to Improve Outcomes and Neurologic Function

Phase II / Phase III Interventional Acute Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: JX10, Placebo.
Who it may be relevant to: Registry conditions: Acute Ischemic Stroke. Basic parameters: 18 years — 90 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Belgium, Bulgaria, Canada, China +13
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

Efficacy: Proportion of participants with no or minimal symptoms (mRS score 0-1) at 90 days [Time frame: 90 days]
Safety: Incidence of symptomatic intracranial hemorrhage within 36 hours post-randomization [Time frame: Within 36 hours post-randomization]

Secondary outcome measures (4)

Ordinal mRS score (0-6), based on a 6-point ordinal scale at 90 days [Time frame: 90 days]
Proportion of participants with functional independence at 90 days [Time frame: 90 days]
Incidence of adverse events (AEs) and serious adverse events (SAEs) [Time frame: 90 days]
Incidence of major bleeding within 24 hours and 14 days of study treatment [Time frame: Within 24 hours and 14 days of study treatment]

Eligibility criteria

Inclusion criteria

Age ≥ 18 and ≤ 90 years old.
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).
Radiographic evidence of salvageable tissue.
Pre-treatment score of NIHSS ≥ 5.

Exclusion criteria

Radiographic findings pre-randomization of any of the following:

Large core infarction, or
Occlusion in more than 1 vascular territory, or
Significant mass effect or clinically significant cerebral edema, or
Evidence of acute intracranial or extracranial hemorrhage, intracranial tumor (except small meningioma), neoplasm, or arteriovenous malformation), or
Clinical history, past imaging, or clinical judgement suggests that the intracranial occlusion is chronic.
Medical history or active clinically significant bleeding, lesions, or conditions (at the investigator's judgement) considered to be of significant risk for major bleeding.
Severe, uncontrolled hypertension (systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg) that cannot be controlled with antihypertensive therapy.
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.
Major trauma, surgery, or invasive procedures.
Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations of this study.
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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

United States · 17 centers

Corxel Investigational Site — Long Beach
Corxel Investigational Site — Sacramento
Corxel Investigational Site — Colorado Springs
Corxel Investigational Site — Washington D.C.
Corxel Investigational Site — Delray Beach
Corxel Investigational Site — Chicago
Corxel Investigational Site — Wichita
Corxel Investigational Site — Baltimore
… and 9 more centers

China · 14 centers

Corxel Investigational Site — Baotou
Corxel Investigational Site — Beijing
Corxel Investigational Site — Beijing
Corxel Investigational Site — Changchun
Corxel Investigational Site — Guangzhou
Corxel Investigational Site, — Harbin
Corxel Investigational Site — Harbin
Corxel Investigational Site — Kaili
… and 6 more centers

Japan · 10 centers

Corxel Investigational Site — Fukuoka
Corxel Investigational Site — Hyōgo
Corxel Investigational site — Ibaraki
Corxel Investigational Site — Kamakura
Corxel Investigational Site — Meguro City
Corxel Investigational Site — Mitaka
Corxel Investigational Site — Miyagi
Corxel Investigational site — Toyota
… and 2 more centers

Spain · 8 centers

Corxel Investigational Site — A Coruña
Corxel Investigational Site — Albacete
Corxel Investigational Site — Barcelona
Corxel Investigational Site — Girona
Corxel Investigational Site — Madrid
Corxel Investigational Site — Málaga
Corxel Investigational Site — Seville
… and 1 more center

Bulgaria · 5 centers

Corxel Investigational Site — Blagoevgrad
Corxel Investigational Site — Burgas
Corxel Investigational Site — Pleven
Corxel Investigational Site — Plovdiv
Corxel Investigational Site — Sofia

Germany · 4 centers

Corxel Investigational Site — Altenburg
Corxel Investigational Site — Leipzig
Corxel Investigational Site — Lübeck
Corxel Investigational Site — Trier

Greece · 4 centers

Corxel Investigational Site — Athens
Corxel Investigational Site — Chaïdári
Corxel Investigational Site — Pátrai
Corxel Investigational Site — Thessaloniki

Serbia · 4 centers

Corxel Investigational Site — Belgrade
Corxel Investigational Site — Kragujevac
Corxel Investigational Site — Niš
Corxel Investigational Site — Novi Sad

Canada · 2 centers

Corxel Investigational Site — Edmonton
Corxel Investigational Site — Kingston

France · 2 centers

Corxel Investigational site — Lille
Corxel Investigational site — Paris

Italy · 2 centers

Corxel Investigational Site — Pavia
Corxel Investigational Site — Roma

Latvia · 2 centers

Corxel Investigational Site — Daugavpils
Corxel Investigational Site — Riga

Lithuania · 2 centers

Corxel Investigational Site — Kaunas
Corxel Investigational Site — Vilnius

Portugal · 2 centers

Corxel Investigational Site — Braga
Corxel Investigational Site — Loures

Thailand · 2 centers

Center list to be confirmed — check the primary protocol.

Belgium · 1 center

Corxel Investigational Site — Ghent

Malaysia · 1 center

Corxel Investigational Site — Kuching

South Korea · 1 center

Corxel Investigational Site — Seoul

Identifiers

NCT: NCT06990867 · JX10002

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗