Improving outcomes for patients with acute ischemic stroke using JX10

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of JX10 compared to a placebo in patients with acute ischemic stroke who seek treatment within 4.5 to 24 hours of symptom onset. Participants will be randomly assigned to receive either JX10 at varying doses or a placebo in two parts, with the primary focus on improving functional outcomes as measured by the modified Rankin Scale. Additionally, the study will assess the risk of symptomatic intracranial hemorrhage associated with JX10 treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Corxel Investigational Site
  Long Beach, California, United States Recruiting
• Corxel Investigational Site
  Los Angeles, California, United States Recruiting
• Corxel Investigational Site
  Sacramento, California, United States Recruiting
• Corxel Investigational Site
  Colorado Springs, Colorado, United States Recruiting
• Corxel Investigational Site
  Washington D.C., District of Columbia, United States Recruiting
• Corxel Investigational Site
  Delray Beach, Florida, United States Recruiting

+54 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Corxel Pharmaceuticals Study Information Center
• Email: Information.center@corxelbio.com
• Phone: 201-268-3723

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.