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news.US-based Evoke Pharma has completed patient enrollment in its thorough electrocardiogram (ECG) (QT) trial of its lead product candidate EVK-001.
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Currently, EVK-001 is in a Phase III clinical trial for the relief of symptoms related with acute and recurrent gastroparesis in women with diabetes mellitus.
A total of 48 patients were enrolled in the double-blind, double-dummy, four-way crossover trial, ahead of the company’s original projected timeframe.
Evoke president and CEO Dave Gonyer said consistent with its continued commitment to the efficient clinical development of EVK-001, the company has started and completed enrollment of this study ahead of schedule.
"Given the full enrollment status, we now expect to provide top-line data from the study later this year rather than in 2015," Gonyer said.
The trial is designed to evaluate the effect of EVK-001 on cardiac ventricular repolarization, specifically the QT-interval.
Before starting the trial, the company has submitted a study protocol to the US Food and Drug Administration (FDA) for their review.
The trial is being conducted to meet one of the two remaining trials requested by the FDA as requirements for submission of a new drug application (NDA) for EVK-001.