Status:
RECRUITING
Optimizing Reperfusion to Improve Outcomes and Neurologic Function
Lead Sponsor:
Corxel Pharmaceuticals
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
PHASE3
Brief Summary
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 th...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
740 Patients enrolled
Trial Details
Trial ID
NCT06990867
Start Date
May 15 2025
End Date
December 31 2029
Last Update
October 30 2025
Active Locations (41)
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1
Corxel Investigational Site
Long Beach, California, United States, 90806
2
Corxel Investigational Site
Chicago, Illinois, United States, 60616
3
Corxel Investigational Site
Wichita, Kansas, United States, 67214
4
Corxel Investigational Site
Baltimore, Maryland, United States, 21215