Transcranial Ultrasound in Clinical SONothrombolysis
Information source: ImaRx Therapeutics
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Ischemic Stroke
Intervention: MRX-801 (Drug); Placebo (Drug)
Phase: Phase 1/Phase 2
Status: Terminated
Sponsored by: ImaRx Therapeutics Official(s) and/or principal investigator(s):
Carlos Molina Cateriano, MD, Study Director, Affiliation: University Hospital Vall d'Hebron, Barcelona, Spain
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.
Clinical Details
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 design: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Incidence of symptomatic intracranial hemorrhage
Secondary outcome: Rate of recanalization of occluded arteryIndependent outcome (modified Rankin Scale 0-2)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Bichat - Claude Bernard University Hospital and Medical School, Paris, France
University of Alabama, Birmingham, Alabama 35249, United States
Barrow Neurology Clinics at St. Joseph's Hospital, Phoenix, Arizona 85013, United States
California Pacific Medical Center, San Francisco, California 94115, United States
Hoag Memorial Hospital, Newport Beach, California 92658, 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
Additional Information
Starting date: December 2006
Ending date: March 2008
Last updated: April 11, 2008
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