ORION · JX10002

The ORION study evaluates the efficacy and safety of the drug JX10 in patients with late-presentation acute ischemic stroke. The primary goal is to optimize reperfusion to promote better clinical outcomes and improvements in neurological function.

ORION: a multicenter, double-blind, placebo-controlled, randomized, parallel-group phase 2/3 study evaluating the efficacy and safety of JX10 in late-presenting acute ischemic stroke, aiming to optimize reperfusion and improve outcomes and neurological function.

Sponsor: CORXEL

Phase: III

Status: Recruiting

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Public study eligibility criteria

Inclusion

  • 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

  • 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 \ 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.