A Phase II, Randomized, Placebo-Controlled, Double-Blind, Adaptive Study to Assess the Safety and Efficacy of Intravenous J147 Combined With Endovascular Therapy in Patients With Acute Ischemic Stroke
Abrexa Pharmaceuticals, Inc.
Summary
The goal of this clinical trial is to find out if the drug J147 improves outcomes for persons who have had an ischemic stroke. It also will learn about the safety of J147 when given by injection to stroke patients. Researchers will compare the outcomes of those who receive J147 after therapy to clear the blood clot to those who don't receive J147. Participants will be asked to undergo a series of three to four magnetic resonance imaging (MRI) brain scans, and blood samples will be collected at several time points. Participants will also be evaluated to measure several aspects of brain function.
Description
This is a prospective, multicenter, double-blind, randomized, placebo-controlled, adaptive Phase II clinical study to evaluate the administration of J147 Emulsion for Injection (J147) in patients with acute ischemic stroke (AIS) with confirmed large vessel occlusion who undergo mechanical thrombectomy without intravenous thrombolytic therapy (alteplase or tenecteplase) and are candidates for reperfusion therapies. Participants will undergo mechanical thrombectomy per standard of care. Following confirmation of successful reperfusion, eligible participants will receive a single intravenous bol…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Signed informed consent obtained from the patient or legally authorized representative. * A new focal disabling neurologic deficit consistent with acute cerebral ischemia. * Baseline NIHSS ≥5 and ≤25 points obtained prior to randomization with a disabling neurological deficit as determined by clinical judgement. * Pre-stroke mRS score of 0-2. * Availability to be treated within 24 hours of last known well. * Candidates to receive EVT treatment without IV thrombolytic therapy. Such patients should be initiated as recommended by the local standard of care for the early man…
Interventions
- DrugJ147 Emulsion for Injection
J147 Emulsion for Injection, 20 mg/mL for IV administration, low dose 1.6 mg/kg, high dose 2.5 mg/kg, single IV injection
- OtherPlacebo
Vehicle without J147, single IV injection
Location
- Dell Seton Medical Center at the University of Texas at AustinAustin, Texas