N/A
Completed N=765
DS-5565 Phase III Study for Post-herpetic Neuralgia
Post-Herpetic Neuralgia
Source: ClinicalTrials.gov NCT02318719 ↗
Enrolled (actual)
765
Serious AEs
2.0%
Results posted
Nov 2020
Primary outcomePrimary: Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia — -0.10; -0.39; -0.54; -0.46 units on a scale — p=0.0170
Summary
Investigate the efficacy and safety of DS-5565 in subjects with Post-Herpetic Neuralgia (PHN) in comparison to placebo
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Oral Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia |
-0.10; -0.39; -0.54; -0.46; -0.33; -0.72 | 0.0170 sig |
| SECONDARY Change in Visual Analog Scale (VAS) Pain From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Asian Participants With Post-herpetic Neuralgia |
-0.70; 4.60; -8.30; -8.60; -8.70; -10.00 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02318719). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.