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

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-07-18
• Study First Submitted QC: 2007-07-19
• Study First Posted: 2007-07-20
• Study Completion: 2008-03
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-11
• Last Update Posted: 2008-04-15

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

Name	Time	Method
Incidence of symptomatic intracranial hemorrhage	36 hours

Secondary Outcome Measures

Name	Time	Method
Rate of recanalization of occluded artery	120 minutes
Independent outcome (modified Rankin Scale 0-2)	90 days

Trial Locations

Locations (14)

Barrow Neurology Clinics at St. Joseph's Hospital; 🇺🇸 Phoenix, Arizona, United States

Christiana Care Health System; 🇺🇸 Newark, Delaware, United States

University of Rochester; 🇺🇸 Rochester, New York, United States

Bichat - Claude Bernard University Hospital and Medical School; 🇫🇷 Paris, France

Hoag Memorial Hospital; 🇺🇸 Newport Beach, California, United States

California Pacific Medical Center; 🇺🇸 San Francisco, California, United States

St. Louis University School of Medicine; 🇺🇸 St. Louis, Missouri, United States

University of Texas; 🇺🇸 Houston, Texas, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Lehigh Valley Hospital; 🇺🇸 Allentown, Pennsylvania, United States

Colorado Neurological Institute; 🇺🇸 Englewood, Colorado, United States

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States

Methodist Hospital Neurological Institute; 🇺🇸 Houston, Texas, United States