This is a randomized, placebo controlled, parallel group dose escalation trial to evaluate the safety, tolerability, and activity of four sequential dose tiers of MRX-801 and ultrasound as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
72
University of Alabama
Birmingham, Alabama, United States
Barrow Neurology Clinics at St. Joseph's Hospital
Phoenix, Arizona, United States
Hoag Memorial Hospital
Incidence of symptomatic intracranial hemorrhage
Time frame: 36 hours
Rate of recanalization of occluded artery
Time frame: 120 minutes
Independent outcome (modified Rankin Scale 0-2)
Time frame: 90 days
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Newport Beach, California, United States
California Pacific Medical Center
San Francisco, California, United States
Colorado Neurological Institute
Englewood, Colorado, United States
Christiana Care Health System
Newark, Delaware, United States
University of Miami
Miami, Florida, United States
St. Louis University School of Medicine
St Louis, Missouri, United States
University of Rochester
Rochester, New York, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
...and 4 more locations