Domenico Merante
Senior Director Clinical Development,
Daiichi Sankyo Development Ltd. Chiltern Place, Chalfont Park, Gerrards Cross, Buckinghamshire-SL9 0BG
United Kingdom
Review Article
Developing New Molecules for the Treatment of Painful Diabetic Peripheral Neuropathy: Is it Feasible given the Magnitude of the Placebo Response in Proof of Concept Clinical Studies
Author(s): Domenico Merante, George Skouteris and Rayaz MalikDomenico Merante, George Skouteris and Rayaz Malik
Randomised, double blind, placebo controlled studies are necessary in neuropathic pain clinical research arena. Few drugs are approved for the indication of painful Diabetic Peripheral Neuropathy (DPN): typically these drugs lose their therapeutic response over time and have far from an ideal tolerability risk profile. In addition to that, the response to placebo continues to represent a significant challenge in clinical trials of painful DPN, as well as any other neuropathic pain condition. Hence to date few molecules have progressed to phase 3 in painful DPN and even fewer have gained approval. Thus several studies failed because the primary endpoint of statistical superiority to placebo and a clinically relevant reduction of ADPS (Average Daily Pain Score) were not achieved. Any attempt to mitigate the placebo response in this condition may allow f.. View More»
