BioDelivery Sciences International, a specialty pharmaceutical company, has randomized more than half of the planned number of patients required for its ongoing initial phase III study of Clonidine Topical Gel, BDSI's proposed treatment for painful diabetic neuropathy (PDN).
The intent of the study will be to demonstrate the efficacy and safety of Clonidine Topical Gel for the treatment of PDN. An interim analysis of the study, which will be based on the first 50% of patients entering the study, now is anticipated to occur in the third quarter of 2014. It was earlier projected based on estimated patient enrollment the interim analysis would occur in fourth quarter of this year. The purpose of the interim analysis is to confirm the assumptions regarding the study sample size and allow for an increase if needed.
"Early enrollment in our RHAPSODY study is ahead of schedule as we are using very experienced investigative sites with substantial patient populations with painful diabetic neuropathy, allowing us to get to our interim results earlier," said Dr. Andrew Finn, executive vice president of Product Development. "We anticipate this rate of enrollment may not be sustained as the initial backlog of patients subsides; however, if no additional patients are needed following the interim analysis, it is possible that we may have final results prior to first quarter of 2015. We will provide future updates on the timing of study completion."
The phase III trial, known as the RHAPSODY Study, is a multicenter, randomized, double blind, placebo controlled study to determine the efficacy and safety of Clonidine Topical Gel in the treatment of PDN. The study is being conducted in subjects with functional skin nociceptors, which is the population of patients that demonstrated a statistically significant difference compared to placebo on the primary efficacy endpoint in a previously performed phase II study. Approximately 140 adult subjects will be randomized to receive either Clonidine Topical Gel or a placebo gel for 12 weeks.