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CLOTBUSTER trial enrollment continues unmodified after first interim analysis

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Cerevast Therapeutics has been instructed by an independent Data Safety Monitoring Board to continue enrollment as planned for a trial assessing an ultrasound device for the treatment of acute ischemic stroke, following the results of its first interim analysis.

The phase 3, double blind CLOTBUSTER trial is designed to evaluate the safety and efficacy of Clotbust ER, a noninvasive ultrasound device intended for use in combination with standard IV thrombolytic therapy in patients with ischemic stroke, according to a company press release.

The first interim analysis included 250 patients randomly assigned to receive thrombolysis and the device or standard care alone. The primary endpoint was 90-day functional recovery as indicated by the modified Rankin scale. After completion of this analysis, the DSMB recommended that the company continue enrollment in the trial without protocol modifications. The DSMB also required no additional modification after separate safety reviews conducted upon enrollment of 50, 100, 200 and 300 patients.

A second interim analysis will be conducted upon the collection of data related to the primary efficacy endpoint for approximately 540 patients, according to the release.

“Clearing the prespecified futility threshold and four independent safety reviews represents a significant step toward the continued advancement of … Clotbust ER as a potential new therapy for stroke patients,” principal investigator Andrei V. Alexandrov, MD, professor and chairman of the neurology department at University of Tennessee Health Science Center, Memphis, stated in the release.

CLOTBUSTER is projected to include a total of 800 patients with acute ischemic stroke across more than 60 stroke facilities worldwide. The trial will also assess the incidence of symptomatic intracranial hemorrhage as the primary safety endpoint. Other evaluated endpoints will include complete vessel recanalization, assessed in a subgroup who receive pre- and post-treatment MRI or CT angiography, according to the release.