Gozani S, Megerian T, Waninger A, Xie L,Wernicke J
Automated Nerve Conduction Testing Technology to Assess Peripheral
Nerve Function in Diabetic Neuropathic Pain Patients During Duloxetine Treatment
Presented at 2004 Annual Meeting of the ADA

Study Design
• 334 patients with previously reported Diabetic Neuropathic Pain (DNP) participated in a multi-center, parallel, double-blind placebo-controlled trial over 12 weeks
• Patients randomized to receive placebo, duloxetine 60mg QD, or duloxetine 60mg BID
• Ulnar and peroneal NCS were performed using the NC-stat System
• NCS performed at baseline and endpoint to determine if duloxetine degraded motor and large sensory fiber function

Key Results
• The NC-stat System demonstrated Relative Inter-trial Variation (RIV) values of 7.5% for peroneal F-wave latency, 8.5% for the ulnar DSL, and 11.5% for the ulnar F-wave latency. These values are comparable to RIVs obtained in multicenter trials utilizing multiple investigators, and support the use of the NC-stat System as an outcome measure for neuropathy trials.
• This data suggest that Duloxetine does not alter motor and large sensory nerve fiber function in DNP patients