- Interim analysis results expected in Q3 2008 -
TORONTO, March 10 /PRNewswire-FirstCall/ - Fralex Therapeutics Inc. (TSX:FXI) ("Fralex" or the "Company"), a medical technology company developing a non-invasive neuromodulation device, today announced the randomization of the 100th patient into the RELIEF study. RELIEF is a multi-centre, double-blind placebo-controlled randomized clinical trial designed to assess the safety and efficacy of Complex Neural Pulse (CNP(TM)) therapy for the relief of chronic pain associated with fibromyalgia.
The data from the first 100 patients will serve as input to an interim analysis ("IA") which will lead to a determination of the number of patients required - between 200 and 300 - to achieve statistical significance at the primary efficacy endpoint. Enrolment will not pause following the randomization of the 100th patient. The results of the IA are expected to be available in Q3 2008.
"The randomization of 100 patients into our pivotal RELIEF trial is a significant milestone for Fralex. Results of the interim analysis will allow us to predict the number of subjects required to achieve statistical significance," said Avi Grewal, President and CEO of Fralex. "We believe that our CNP therapy has the potential to be a safe and effective, non-drug, non-invasive treatment for pain associated with fibromyalgia. The information from the interim analysis will be critical for developing timelines for the commercialization of our CNP therapy."
The RELIEF trial is being conducted in the U.S. and Canada across 19
centres, under an Investigational Device Exemption ("IDE") from the U.S.
FDA and an Investigational Testing Authorization ("ITA") from Health
Canada. Patients are randomized on a one-to-one basis to receive CNP or
placebo for 12 weeks. The primary efficacy endpoint will be a statistically
significant difference between the active and placebo groups in the
reduction of their Numerical Rating S
|SOURCE Fralex Therapeutics Inc.|
Copyright©2008 PR Newswire.
All rights reserved