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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00504842

Acronym

TUCSON

Enrollment

Registered

2007-07-20

Start date

2006-12-31

Completion date

2008-03-31

Last updated

2008-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke, Microbubbles, Transcranial Doppler ultrasound, TIBI, Symptomatic Intracranial Hemorrhage, modified Rankin Scale, Recanalization, Perflutren

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.

Interventions

DRUGMRX-801

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of symptomatic intracranial hemorrhage	36 hours

Secondary

Measure	Time frame
Rate of recanalization of occluded artery	120 minutes
Independent outcome (modified Rankin Scale 0-2)	90 days

Countries

France, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026