Phase 3
Completed N=834
DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain
Diabetic Peripheral Neuropathic Pain
Source: ClinicalTrials.gov NCT02318706 ↗
Enrolled (actual)
834
Serious AEs
5.6%
Results posted
Nov 2020
Primary outcomePrimary: Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain — -0.26; -0.39; -0.40; -0.60 units on a scale — p=0.8773
◆ Published Evidence
Established
48citations · ~10 / year
Safety and Efficacy of Mirogabalin for Peripheral Neuropathic Pain: Pooled Analysis of Two Pivotal Phase III Studies.
Summary
Investigate the efficacy and safety of DS-5565 in subjects with Diabetic Peripheral Neuropathic Pain (DPNP) in comparison to placebo
Linked Publications
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Safety and Efficacy of Mirogabalin for Peripheral Neuropathic Pain: Pooled Analysis of Two Pivotal Phase III Studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain |
-0.26; -0.39; -0.40; -0.60; -0.46; -0.60 | 0.8773 |
| SECONDARY Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain |
-0.90; -4.00; -7.00; -6.20; -7.20; -7.80 | — |
Eligibility Criteria
Inclusion Criteria
- Type 1 or type 2 diabetes mellitus at screening
- Painful distal symmetric polyneuropathy
- At screening, a pain scale of ≥ 40 mm
Exclusion Criteria
- HbA1c (National Glycohemoglobin Standardization Program) > 10.0%
Data sourced from ClinicalTrials.gov (NCT02318706) and the linked publication. 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.