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Phase III Study Evaluates Ultrasound Device for Emergency Treatment of Ischemic Stroke

Safety monitoring board OK's further enrollment

An ongoing phase III clinical study is evaluating the Clotbust ER ultrasonic headframe (Cerevast Therapeutics) for the treatment of acute ischemic stroke.

The trial has cleared its pre-specified futility threshold and four independent safety reviews. As a result, the study’s independent data safety monitoring board (DSMB) recommended that the trial continue enrollment as planned.

The interim safety analysis was conducted in 250 patients. The trial’s primary efficacy endpoint is 90-day functional recovery, as measured by the modified Rankin Scale (mRS) — a widely used clinical outcome measure for stroke clinical trials.

The CLOTBUSTER trial is a randomized double-blind study evaluating the efficacy and safety of the Clotbust ER ultrasound device in combination with standard intravenous (IV) thrombolytic therapy with alteplace (Activase, Genentech), a tissue plasminogen activator (tPA). The study is designed to randomly assign up to 800 evaluable patients with ischemic stroke to treatment with either the Clotbust ER ultrasound device in combination with standard IV tPA therapy or IV tPA therapy alone.

In addition to evaluating 90-day functional recovery as the primary efficacy endpoint, the study is measuring the incidence of symptomatic intracranial hemorrhage as the primary safety endpoint. The study is also evaluating complete vessel recanalization as a secondary endpoint in a subset of patients who have undergone pre- and post-treatment magnetic resonance imaging (MRI) or computed tomography (CT) angiography. The trial is being conducted in 14 countries.

To date, more than 460 subjects have been enrolled. The second interim analysis will be conducted after 90-day functional recovery data have been collected from approximately 540 subjects. Before performing the first interim analysis, the DSMB conducted four separate unblinded safety reviews after 50, 100, 200, and 300 subjects had been enrolled.

Clotbust ER is an investigational, first-in-class ultrasound device designed for the treatment of ischemic stroke. Intended for rapid deployment in the emergency-room setting, the device has been engineered to non-invasively deliver therapeutic ultrasound energy to the region of the occluded vessel in the brain. Clinical data from five independent studies have demonstrated that combining the acoustic energy of ultrasound with conventional IV tPA therapy dissolves blood clots more completely and provides patients with better long-term clinical outcomes compared with IV tPA therapy alone. Based on the results of these studies, the Clotbust ER device received European clearance in December 2011.

Approximately 795,000 strokes occur in the U.S. each year. Stroke represents the third leading cause of death in the U.S. It is the leading cause of serious long-term disability, currently affecting more than 3 million Americans, with an annual economic burden to the U.S. health care system of more than $73 billion dollars. tPA is the only FDA-approved treatment for ischemic stroke.

Source: PR Newswire; September 23, 2014.

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