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Transcranial Ultrasound in Clinical SONothrombolysis (TUCSON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00504842
Recruitment Status : Terminated (Sponsor decision)
First Posted : July 20, 2007
Last Update Posted : April 15, 2008
Sponsor:
Information provided by:
ImaRx Therapeutics

Tracking Information
First Submitted Date  ICMJE July 18, 2007
First Posted Date  ICMJE July 20, 2007
Last Update Posted Date April 15, 2008
Study Start Date  ICMJE December 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2007)
Incidence of symptomatic intracranial hemorrhage [ Time Frame: 36 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2007)
  • Rate of recanalization of occluded artery [ Time Frame: 120 minutes ]
  • Independent outcome (modified Rankin Scale 0-2) [ Time Frame: 90 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcranial Ultrasound in Clinical SONothrombolysis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Acute Ischemic Stroke
Intervention  ICMJE
  • Drug: MRX-801
  • Drug: Placebo
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: July 19, 2007)
72
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00504842
Other Study ID Numbers  ICMJE MRX-06-101-CP-01-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE ImaRx Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Carlos Molina Cateriano, MD University Hospital Vall d'Hebron, Barcelona, Spain
PRS Account ImaRx Therapeutics
Verification Date April 2008

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