US-based pharmaceutical firm BioDelivery Sciences International (BDSI) has started patient enrolment in the RHAPSODY Study, a Phase III clinical trial of Clonidine Topical Gel to treat painful diabetic neuropathy (PDN).
The multicentre, randomised, double blind, placebo controlled Phase III trial is designed to determine the efficacy and safety of Clonidine Topical Gel in the treatment of pain associated with painful diabetic neuropathy.
The Phase III trial will be carried out in subjects showing functional skin nociceptors, which is the population of patients that showed a statistically significant difference compared to placebo on the primary efficacy endpoint in a previously conducted Phase II trial.
In the Phase III trial, patients will be given either Clonidine Topical Gel or a placebo gel.
A total of 140 adult patients will be enrolled in the trial, which includes a double blind treatment Phase of 12 weeks.
Interim results of the Phase III trial are expected during the fourth quarter of 2014, while final results are scheduled in the first quarter of 2015.
BioDelivery Sciences vice-president of clinical research Adrian Hepner said the company plans to conduct an independent interim analysis based on 50% of the patients completed.
"We anticipate that results of the interim analysis will be available in the fourth quarter of this year, and if the results confirm current study assumptions, the second Phase III trial of similar size and scope will be initiated at that time," Hepner said. "This timeline could allow for a 2016 NDA submission."
The US FDA agreed with the overall clinical programme proposed by BDSI, which includes two well-controlled studies and one long-term safety study in patients suffering from PDN, the duration of treatment required for safety assessment, the plan for data integration from prior and planned clinical trials and interim analysis of the first pivotal trial.
FDA also granted fast-track designation for the programme, which recognises the need of developing new therapies for PDN.