RecruitingAcute Ischemic Stroke

Optimizing Reperfusion to Improve Outcomes and Neurologic Function

Eligible age

18–90 yrs

Accepts

All genders

Locations

13 states

Healthy volunteers

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About this study

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.

Sponsor: Corxel Pharmaceuticals

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.