Recruiting PHASE2, PHASE3 Acute Ischemic Stroke

New treatment option for Acute Ischemic Stroke

Official title Optimizing Reperfusion to Improve Outcomes and Neurologic Function

ClinicalTrials.gov ID: NCT06990867

What this study is testing

What is JX10?

JX10 is an investigational medicine, being studied as a potential treatment for acute ischemic stroke.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 3: a large, late-stage study
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 90

You may be able to join if

  • 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...
  • Radiographic evidence of salvageable tissue.
  • Pre-treatment score of NIHSS ≥ 5.

You likely can't join if

  • 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.
See the full eligibility criteria
Who can join
  • 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...
  • Radiographic evidence of salvageable tissue.
  • Pre-treatment score of NIHSS ≥ 5.
What rules you out
  • 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 \ 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...

The study team makes the final eligibility decision.

Where it's taking place

  • Long Beach, California, United States
  • Sacramento, California, United States
  • Colorado Springs, Colorado, United States
  • Washington D.C., District of Columbia, United States
  • Delray Beach, Florida, United States
  • Chicago, Illinois, United States
  • Wichita, Kansas, United States
  • Baltimore, Maryland, United States
  • Kalamazoo, Michigan, United States
  • Traverse City, Michigan, United States
  • St Louis, Missouri, United States
  • Great Neck, New York, United States
  • New York, New York, United States
  • Toledo, Ohio, United States
  • Tulsa, Oklahoma, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Ghent, Belgium
  • Blagoevgrad, Bulgaria
  • Burgas, Bulgaria

+ 61 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Long Beach, California, United States; Sacramento, California, United States; Colorado Springs, Colorado, United States; Washington D.C., District of Columbia, United States; Delray Beach, Florida, United States; Chicago, Illinois, United States and 75 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.