Transcranial Ultrasound in Clinical SONothrombolysis "TUCSON"

Terminated

Phase 1/2 Results

Trial Description

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.

Trial Stopped: Sponsor decision

Conditions

Interventions

  • MRX-801 microbubbles +tPA Therapy (SonoLysis + tPA Therapy)Drug
    Intervention Desc: SonoLysis+tPA therapy involves the administration of proprietary MRX-801 microbubbles and ultrasound in conjunction with tPA. To administer our SonoLysis+tPA therapy, MRX-801 microbubbles and tPA are injected intravenously into the bloodstream. The MRX-801 microbubbles are distributed naturally throughout the body including to the site of the blood clot. The ultrasound is then administered to the site of the blood clot, and the energy from the ultrasound causes the MRX-801 microbubbles to expand and contract vigorously, or cavitate. We believe this cavitation both mechanically breaks up the blood clot and helps the administered tPA permeate the clot to facilitate clot dissolving activity. The gas released by the MRX-801 microbubbles is then cleared from the body simply by exhaling, and the lipid shell is metabolized like other fats in the body.
  • Placebo Drug
  • MRX-801 Drug

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients randomized to either: cohort 1 - treatment group (one vial of MRX-801, ultrasound, and tPA) or control group (tPA alone), or: cohort 2 - (two vials of MRX-801, ultrasound, and tPA) or control group (tPA alone). All patients are assessed for clinical recovery at 23-36 hours, and again at 90 days for functional and neurological outcomes.

Outcomes

Type Measure Time Frame Safety Issue
Primary Incidence of symptomatic intracranial hemorrhage at 36 hours.
Secondary Rate of recanalization of occluded artery at 120 minutes; independent outcome (modified Rankin Scale 0-2) at 90 days.
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

Sponsors