RENOVIS ANNOUNCES RESULTS OF PHASE II SCIATICA STUDY
Renovis has announced the results of its Phase II clinical trial studying REN-1654 in patient-volunteers with sciatica, a form of neuropathic pain.
The results indicate that, although REN-1654 showed a positive trend in pain relief, it did not reach statistical significance in its primary endpoint of change in average daily spontaneous pain ratings at the end of a three-week treatment period compared to placebo.
A planned analysis of secondary endpoints in the study showed a statistically significant reduction in maximum daily leg pain at the end of weeks one and two in subjects treated with REN-1654 compared with placebo, but the reduction in maximum daily leg pain was not statistically significant after three weeks of treatment due to a spontaneous reduction of pain in the placebo group.
The double-blinded, placebo-controlled, multicenter study enrolled 74 patient-volunteers who had developed leg pain due to lumbosacral radiculopathy of no more than 12 weeks duration prior to enrollment.