Transcranial Ultrasound in Clinical SONothrombolysis (TUCSON)

April 11, 2008 updated by: ImaRx Therapeutics

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Bichat - Claude Bernard University Hospital and Medical School
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University Of Alabama
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurology Clinics at St. Joseph's Hospital
    • California
      • Newport Beach, California, United States, 92658
        • Hoag Memorial Hospital
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Colorado Neurological Institute
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Care Health System
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Missouri
      • St. Louis, Missouri, United States, 63104
        • St. Louis University School of Medicine
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas
      • Houston, Texas, United States, 77030
        • Methodist Hospital Neurological Institute
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of symptomatic intracranial hemorrhage
Time Frame: 36 hours
36 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of recanalization of occluded artery
Time Frame: 120 minutes
120 minutes
Independent outcome (modified Rankin Scale 0-2)
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImaRx Therapeutics

Investigators

  • Study Director: Carlos Molina Cateriano, MD, University Hospital Vall d'Hebron, Barcelona, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

July 18, 2007

First Submitted That Met QC Criteria

July 19, 2007

First Posted (Estimate)

July 20, 2007

Study Record Updates

Last Update Posted (Estimate)

April 15, 2008

Last Update Submitted That Met QC Criteria

April 11, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRX-06-101-CP-01-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe