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NCT00504842 Clinical Trial

Transcranial Ultrasound in Clinical SONothrombolysis

Acute Ischemic Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00504842
Other study ID # MRX-06-101-CP-01-01
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received July 18, 2007
Last updated April 11, 2008
Start date December 2006
Est. completion date March 2008

Study information
Verified date April 2008
Source ImaRx Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 72
Est. completion date March 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• MRX-801

• Placebo

Locations
Country Name City State
France Bichat - Claude Bernard University Hospital and Medical School Paris
United States Lehigh Valley Hospital Allentown Pennsylvania
United States University of Alabama Birmingham Alabama
United States Colorado Neurological Institute Englewood Colorado
United States Methodist Hospital Neurological Institute Houston Texas
United States University of Texas Houston Texas
United States University of Miami Miami Florida
United States Christiana Care Health System Newark Delaware
United States Hoag Memorial Hospital Newport Beach California
United States Barrow Neurology Clinics at St. Joseph's Hospital Phoenix Arizona
United States University of Rochester Rochester New York
United States California Pacific Medical Center San Francisco California
United States Swedish Medical Center Seattle Washington
United States St. Louis University School of Medicine St. Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
ImaRx Therapeutics

Countries where clinical trial is conducted

United States,  France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of symptomatic intracranial hemorrhage 36 hours
Secondary Rate of recanalization of occluded artery 120 minutes
Secondary Independent outcome (modified Rankin Scale 0-2) 90 days
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