DS-5565 Phase III Study for Post-herpetic Neuralgia

An Asian, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled 14-Week Study of DS-5565 in Patients With Post-herpetic Neuralgia Followed by a 52-Week Open-label Extension

Investigate the efficacy and safety of DS-5565 in subjects with Post-Herpetic Neuralgia (PHN) in comparison to placebo

[Double Blind Phase] The primary objective is to compare change in the Average Daily Pain Score (ADPS) from baseline to Week 14 in Asian subjects with PHN receiving DS-5565 versus placebo.

[Open Extension Phase] The objective is to assess the long-term safety and efficacy of DS-5565 in subjects with PHN.

Inclusion Criteria:

• PHN defined as pain present for more than 3 months after herpes zoster skin rash at screening
• At screening, a pain scale of ≥ 40 mm

Exclusion Criteria:

• Previous use of neurolytic block