Study Stopped
Sponsor decision
Transcranial Ultrasound in Clinical SONothrombolysis
TUCSON
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
1 other identifier
interventional
72
2 countries
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2006
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 18, 2007
CompletedFirst Posted
Study publicly available on registry
July 20, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedApril 15, 2008
April 1, 2008
July 18, 2007
April 11, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of symptomatic intracranial hemorrhage
36 hours
Secondary Outcomes (2)
Rate of recanalization of occluded artery
120 minutes
Independent outcome (modified Rankin Scale 0-2)
90 days
Interventions
Eligibility Criteria
You may qualify if:
- Acute ischemic stroke
- Occlusion demonstrated by transcranial Doppler ultrasound
- Eligible for tPA
You may not qualify if:
- Right to left cardiac shunt
- Moderate to severe COPD
- Uncontrolled hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
University of Alabama
Birmingham, Alabama, 35249, United States
Barrow Neurology Clinics at St. Joseph's Hospital
Phoenix, Arizona, 85013, United States
Hoag Memorial Hospital
Newport Beach, California, 92658, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
Colorado Neurological Institute
Englewood, Colorado, 80113, United States
Christiana Care Health System
Newark, Delaware, 19718, United States
University of Miami
Miami, Florida, 33136, United States
St. Louis University School of Medicine
St Louis, Missouri, 63104, United States
University of Rochester
Rochester, New York, 14642, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
Methodist Hospital Neurological Institute
Houston, Texas, 77030, United States
University of Texas
Houston, Texas, 77030, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Bichat - Claude Bernard University Hospital and Medical School
Paris, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Carlos Molina Cateriano, MD
University Hospital Vall d'Hebron, Barcelona, Spain
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 18, 2007
First Posted
July 20, 2007
Study Start
December 1, 2006
Study Completion
March 1, 2008
Last Updated
April 15, 2008
Record last verified: 2008-04