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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • JX10

    Drug

    JX10 is a thrombolytic agent.

  • Placebo

    Drug

    Placebo is being used as the comparator.

Treatment groups

740 Participants
are divided into 5 treatment groups
Group A: Part 1 - JX10 (1mg/kg)Experimental treatment 1 intervention
Group B: Part 1 - JX10 (3mg/kg)Experimental treatment 1 intervention
Group C: Part 1 - PlaceboPlacebo comparator 1 intervention
Group D: JX10 Part 2 - (1 or 3 mg/kg)Experimental treatment 1 intervention
Group E: Part 2 - PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy: Proportion of participants with no or minimal symptoms (mRS score 0-1) at 90 days

Time frame
90 days
2

Safety: Incidence of symptomatic intracranial hemorrhage within 36 hours post-randomization

Time frame
Within 36 hours post-randomization

Secondary outcomes

1

Ordinal mRS score (0-6), based on a 6-point ordinal scale at 90 days

Time frame
90 days
2

Proportion of participants with functional independence at 90 days

Functional independence: mRS score 0-2

Time frame
90 days
3

Incidence of adverse events (AEs) and serious adverse events (SAEs)

Time frame
90 days
4

Incidence of major bleeding within 24 hours and 14 days of study treatment

Time frame
Within 24 hours and 14 days of study treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Corxel Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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