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Transcranial Ultrasound in Clinical SONothrombolysis

Phase 1
Terminated
Conditions
Acute Ischemic Stroke
Registration Number
NCT00504842
Lead Sponsor
ImaRx Therapeutics
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
72
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Incidence of symptomatic intracranial hemorrhage36 hours
Secondary Outcome Measures
NameTimeMethod
Rate of recanalization of occluded artery120 minutes
Independent outcome (modified Rankin Scale 0-2)90 days

Trial Locations

Locations (14)

University of Alabama

🇺🇸

Birmingham, Alabama, United States

Barrow Neurology Clinics at St. Joseph's Hospital

🇺🇸

Phoenix, Arizona, United States

Hoag Memorial Hospital

🇺🇸

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

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University of Alabama
🇺🇸Birmingham, Alabama, United States

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