Transcranial Ultrasound in Clinical SONothrombolysis (TUCSON)

This study has been terminated.
(Sponsor decision)
Sponsor:
Information provided by:
ImaRx Therapeutics
ClinicalTrials.gov Identifier:
NCT00504842
First received: July 18, 2007
Last updated: April 11, 2008
Last verified: April 2008
  Purpose

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 Intervention Phase
Acute Ischemic Stroke
Drug: MRX-801
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by ImaRx Therapeutics:

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

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

Estimated Enrollment: 72
Study Start Date: December 2006
Study Completion Date: March 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504842

Locations
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
France
Bichat - Claude Bernard University Hospital and Medical School
Paris, France
Sponsors and Collaborators
ImaRx Therapeutics
Investigators
Study Director: Carlos Molina Cateriano, MD University Hospital Vall d'Hebron, Barcelona, Spain
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00504842     History of Changes
Other Study ID Numbers: MRX-06-101-CP-01-01
Study First Received: July 18, 2007
Last Updated: April 11, 2008
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by ImaRx Therapeutics:
Acute Ischemic Stroke
Microbubbles
Transcranial Doppler ultrasound
TIBI
Symptomatic Intracranial Hemorrhage
modified Rankin Scale
Recanalization
Perflutren

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on August 21, 2014