Optimizing Reperfusion to Improve Outcomes and Neurologic Function
ConditionAcute Ischemic Stroke
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-90
SponsorCorxel Pharmaceuticals
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- JX10
- Placebo
Treatment groups
740 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov