Clinical trial NCT00504842: Transcranial Ultrasound in Clinical SONothrombolysis
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Acute Ischemic Stroke
Keywords: Acute Ischemic Stroke
Microbubbles
Transcranial Doppler ultrasound
TIBI
Symptomatic Intracranial Hemorrhage
modified Rankin Scale
Recanalization
Perflutren
Lead sponsor: ImaRx Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-07-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Incidence of symptomatic intracranial hemorrhage
timeFrame: 36 hours
Secondary outcomes:
measure: Rate of recanalization of occluded artery
timeFrame: 120 minutes
measure: Independent outcome (modified Rankin Scale 0-2)
timeFrame: 90 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Phoenix
country: United States
facility: Barrow Neurology Clinics at St. Joseph's Hospital
state: Arizona
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Englewood
country: United States
facility: Colorado Neurological Institute
state: Colorado
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Miami
country: United States
facility: University of Miami
state: Florida
city: St. Louis
country: United States
facility: St. Louis University School of Medicine
state: Missouri
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Methodist Hospital Neurological Institute
state: Texas
city: Houston
country: United States
facility: University of Texas
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Paris
country: France
facility: Bichat - Claude Bernard University Hospital and Medical School
Study officials:
affiliation: University Hospital Vall d'Hebron, Barcelona, Spain
name: Carlos Molina Cateriano, MD
role: STUDY_DIRECTOR
References: