Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

July 18, 2007
April 11, 2008
December 2006
Not Provided
Incidence of symptomatic intracranial hemorrhage [ Time Frame: 36 hours ]
Same as current
Complete list of historical versions of study NCT00504842 on ClinicalTrials.gov Archive Site
  • Rate of recanalization of occluded artery [ Time Frame: 120 minutes ]
  • Independent outcome (modified Rankin Scale 0-2) [ Time Frame: 90 days ]
Same as current
Not Provided
Not Provided
 
Transcranial Ultrasound in Clinical SONothrombolysis
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Acute Ischemic Stroke
  • Drug: MRX-801
  • Drug: Placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
72
March 2008
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France
 
NCT00504842
MRX-06-101-CP-01-01
Yes
Not Provided
ImaRx Therapeutics
Not Provided
Study Director: Carlos Molina Cateriano, MD University Hospital Vall d'Hebron, Barcelona, Spain
ImaRx Therapeutics
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP