Back to resultsTranscranial Ultrasound in Clinical SONothrombolysis (TUCSON)
Primary Purpose
Acute Ischemic Stroke
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
MRX-801
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Acute Ischemic Stroke, Microbubbles, Transcranial Doppler ultrasound, TIBI, Symptomatic Intracranial Hemorrhage, modified Rankin Scale, Recanalization, Perflutren
Eligibility Criteria
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
Sites / Locations
- University of Alabama
- Barrow Neurology Clinics at St. Joseph's Hospital
- Hoag Memorial Hospital
- California Pacific Medical Center
- Colorado Neurological Institute
- Christiana Care Health System
- University of Miami
- St. Louis University School of Medicine
- University of Rochester
- Lehigh Valley Hospital
- Methodist Hospital Neurological Institute
- University of Texas
- Swedish Medical Center
- Bichat - Claude Bernard University Hospital and Medical School
Outcomes
Primary Outcome Measures
Incidence of symptomatic intracranial hemorrhage
Secondary Outcome Measures
Rate of recanalization of occluded artery
Independent outcome (modified Rankin Scale 0-2)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00504842
Brief Title
Transcranial Ultrasound in Clinical SONothrombolysis
Acronym
TUCSON
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 Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
ImaRx Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
Acute Ischemic Stroke, Microbubbles, Transcranial Doppler ultrasound, TIBI, Symptomatic Intracranial Hemorrhage, modified Rankin Scale, Recanalization, Perflutren
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MRX-801
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Incidence of symptomatic intracranial hemorrhage
Time Frame
36 hours
Secondary Outcome Measure Information:
Title
Rate of recanalization of occluded artery
Time Frame
120 minutes
Title
Independent outcome (modified Rankin Scale 0-2)
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Molina Cateriano, MD
Organizational Affiliation
University Hospital Vall d'Hebron, Barcelona, Spain
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Barrow Neurology Clinics at St. Joseph's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Hoag Memorial Hospital
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Colorado Neurological Institute
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Christiana Care Health System
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
St. Louis University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Methodist Hospital Neurological Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Bichat - Claude Bernard University Hospital and Medical School
City
Paris
Country
France
12. IPD Sharing Statement
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Transcranial Ultrasound in Clinical SONothrombolysis
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