Is Nerve Electrophysiology a Robust Primary Endpoint in Clinical Trials of Treatments for Diabetic Peripheral Neuropathy?

• Published in: Diagnostics (Basel) Vol. 12; no. 3; p. 731
• Main Authors: Al-Bazz, Dalal Y, Nelson, Andrew J, Burgess, Jamie, Petropoulos, Ioannis N, Nizza, Jael, Marshall, Anne, Brown, Emily, Cuthbertson, Daniel J, Marshall, Andrew G, Malik, Rayaz A, Alam, Uazman
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 17.03.2022; MDPI
• Subjects: Clinical trials; Diabetes; Diabetic neuropathy; Endothelium; FDA approval; Growth factors; Kinases; nerve electrophysiology; Neurophysiology; Peptides; Peripheral neuropathy; Proteins; Review; Systematic review; nerve electrophysiology; diabetes; peripheral neuropathy

There is currently no FDA-approved disease-modifying therapy for diabetic peripheral neuropathy (DPN). Nerve conduction velocity (NCV) is an established primary endpoint of disease-modifying therapies in DPN and clinical trials have been powered with an assumed decline of 0.5 m/s/year. This paper so...