An Asian, phase 2, multicenter, randomized, double-blind, placebo- and pregabalin-controlled, dose-finding study of DS-5565 in patients with pain associated with diabetic peripheral neuropathy

In subjects with pain associated with DPN receiving DS-5565 at a dose of 5 mg BID, 10 mg BID, or 15 mg BID for 7 weeks including 1-week titration, DS-5565 showed a numerically greater improvement in ADPS than placebo, although these differences versus placebo were not statistically significant for any treatment groups. DS-5565 was tolerated in this population at doses of 5 mg BID, 10 mg BID, and 15 mg BID.