BioCentury
ARTICLE | Clinical News

Clonidine: Phase III amended

August 18, 2014 7:00 AM UTC

BioDelivery Sciences said it will enroll an additional 80 patients in the double-blind, U.S. Phase III RHAPSODY trial to maintain 90% power to detect a statistically significant difference between its clonidine topical gel and placebo. In June, the company completed enrollment of the 140 patients with functional skin nociceptors it initially planned to enroll (see BioCentury, July 21). The increase in enrollment follows a pre-specified interim analysis by an independent biostatistician of data from the first 50% of patients who completed the trial, which was designed to allow for a sample size adjustment to maintain appropriate statistical power.

The company said initial enrollment was about 3 months ahead of schedule, so it still expects top-line data by the end of 1Q15. BioDelivery also reiterated plans to begin a second Phase III trial in early 2015. ...