Efficacy and safety of mirogabalin (DS-5565) for the treatment of diabetic peripheral neuropathic pain: a randomized, double-blind, placebo- and active comparator-controlled, adaptive proof-of-concept phase 2 study.

@article{Vinik2014EfficacyAS,
  title={Efficacy and safety of mirogabalin (DS-5565) for the treatment of diabetic peripheral neuropathic pain: a randomized, double-blind, placebo- and active comparator-controlled, adaptive proof-of-concept phase 2 study.},
  author={Aaron I Vinik and Julio Rosenstock and Uma Sharma and Karen Feins and Ching Jou Hsu and Domenico Merante},
  journal={Diabetes care},
  year={2014},
  volume={37 12},
  pages={3253-61}
}
OBJECTIVE We aimed to identify doses of mirogabalin (DS-5565) providing clinically meaningful efficacy with manageable side effects for treatment of diabetic peripheral neuropathic pain (DPNP). RESEARCH DESIGN AND METHODS Adults (≥18 years) with type 1 or 2 diabetes, HbA₁c ≤10% at screening, and DPNP for ≥6 months were eligible for study participation… CONTINUE READING