Transcranial Ultrasound in Clinical SONothrombolysis

A Phase 1-2, Randomized, Placebo-Controlled, Single-Blind, Dose Escalation Study to Evaluate the Safety, Tolerability, and Activity of Ascending Single Doses of MRX-801 With Continuous Ultrasound Administration in Subjects With Acute Ischemic Stroke Receiving Treatment With Intravenous Tissue Plasminogen Activator

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.

Inclusion Criteria:

• Acute ischemic stroke
• Occlusion demonstrated by transcranial Doppler ultrasound
• Eligible for tPA

Exclusion Criteria:

• Right to left cardiac shunt
• Moderate to severe COPD
• Uncontrolled hypertension