Phase 3
Completed N=35
DS-5565 Phase III Study for Renal Impairment in Japanese Subjects
Diabetic Peripheral Neuropathic Pain · Post-herpetic Neuralgia
Source: ClinicalTrials.gov NCT02607280 ↗
Enrolled (actual)
35
Serious AEs
2.9%
Results posted
Oct 2020
Primary outcomePrimary: Change From Baseline in Average Daily Pain Score (ADPS) at Each Week — -0.14; -0.20; -0.37; -0.50 units on a scale
◆ Published Evidence
Emerging
19citations · ~3 / year
Mirogabalin in Japanese Patients with Renal Impairment and Pain Associated with Diabetic Peripheral Neuropathy or Post-Herpetic Neuralgia: A Phase III, Open-Label, 14-Week Study.
Summary
Investigate the safety and efficacy of DS-5565 in Japanese subjects with Diabetic Peripheral Neuropathic Pain (DPNP) with renal impairment or Post-Herpetic Neuralgia (PHN) with renal impairment.
Linked Publications
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Mirogabalin in Japanese Patients with Renal Impairment and Pain Associated with Diabetic Peripheral Neuropathy or Post-Herpetic Neuralgia: A Phase III, Open-Label, 14-Week Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Average Daily Pain Score (ADPS) at Each Week |
-0.14; -0.20; -0.37; -0.50; -0.85; -1.83 | — |
Eligibility Criteria
Inclusion Criteria
- At screening, creatinine clearance (using the Cockcroft-Gault equation): 15-59 mL/min
- At screening, a pain scale of ≥ 40 mm
- Type 1 or type 2 diabetes mellitus at screening (for patients with diabetic peripheral neuropathic pain DPNP only)-. Painful distal symmetric polyneuropathy (for patients with DPNP only)
- post-herpetic neuralgia PHN defined as pain present for more than 3 months after herpes zoster skin rash at screening (for patients with PHN only)
Exclusion Criteria
- HbA1c (National Glycohemoglobin Standardization Program) > 10.0% (for patients with DPNP only)
- Previous use of neurolytic block (for patients with PHN only)
Data sourced from ClinicalTrials.gov (NCT02607280) 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.