Transcranial Ultrasound in Clinical SONothrombolysis (TUCSON)
This study has been terminated.
(Sponsor decision)
Sponsor:
ImaRx Therapeutics
Information provided by:
ImaRx Therapeutics
ClinicalTrials.gov Identifier:
NCT00504842
First received: July 18, 2007
Last updated: April 11, 2008
Last verified: April 2008
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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 |
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
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 May 23, 2013