Testing JX10 in People With Stroke Who Arrive Late for Care
Tests JX10 against placebo in adults with stroke arriving late.
Plain-language title generated from the registry record
Registry title: Optimizing Reperfusion to Improve Outcomes and Neurologic Function
Key facts
- Where
- Fukuoka, Hyōgo, Ibaraki, Kamakura, Meguro City, Mitaka, Miyagi, Toyota, Yamagata, and Yamaguchi, JapanSee the 10 sites
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Source: NCT06990867, who can take part
Where in Japan
- FukuokaFukuoka, JapanTaking people
- HyōgoHyōgo, JapanTaking people
- IbarakiIbaraki, JapanTaking people
- KamakuraKamakura, JapanTaking people
- Meguro CityMeguro City, JapanTaking people
- MitakaMitaka, JapanTaking people
- MiyagiMiyagi, JapanTaking people
- ToyotaToyota, JapanTaking people
- YamagataYamagata, JapanTaking people
- YamaguchiYamaguchi, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Corxel Pharmaceuticals
- Trial code
- NCT06990867
- Record updated
- 21 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Major trauma, surgery, or invasive procedures; 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; Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations of this study; 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; 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.