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Transcranial Ultrasound in Clinical SONothrombolysis (TUCSON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00504842
Recruitment Status : Terminated (Sponsor decision)
First Posted : July 20, 2007
Last Update Posted : April 15, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Drug: MRX-801 Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2006
Actual Study Completion Date : March 2008

Primary Outcome Measures :
  1. Incidence of symptomatic intracranial hemorrhage [ Time Frame: 36 hours ]

Secondary Outcome Measures :
  1. Rate of recanalization of occluded artery [ Time Frame: 120 minutes ]
  2. Independent outcome (modified Rankin Scale 0-2) [ Time Frame: 90 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00504842

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United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35249
United States, Arizona
Barrow Neurology Clinics at St. Joseph's Hospital
Phoenix, Arizona, United States, 85013
United States, California
Hoag Memorial Hospital
Newport Beach, California, United States, 92658
California Pacific Medical Center
San Francisco, California, United States, 94115
United States, Colorado
Colorado Neurological Institute
Englewood, Colorado, United States, 80113
United States, Delaware
Christiana Care Health System
Newark, Delaware, United States, 19718
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Missouri
St. Louis University School of Medicine
St. Louis, Missouri, United States, 63104
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
United States, Texas
Methodist Hospital Neurological Institute
Houston, Texas, United States, 77030
University of Texas
Houston, Texas, United States, 77030
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
Bichat - Claude Bernard University Hospital and Medical School
Paris, France
Sponsors and Collaborators
ImaRx Therapeutics
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Study Director: Carlos Molina Cateriano, MD University Hospital Vall d'Hebron, Barcelona, Spain
Layout table for additonal information Identifier: NCT00504842    
Other Study ID Numbers: MRX-06-101-CP-01-01
First Posted: July 20, 2007    Key Record Dates
Last Update Posted: April 15, 2008
Last Verified: April 2008
Keywords provided by ImaRx Therapeutics:
Acute Ischemic Stroke
Transcranial Doppler ultrasound
Symptomatic Intracranial Hemorrhage
modified Rankin Scale
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes