DS-5565 Phase III Study for Renal Impairment in Japanese Subjects

Study Overview
=================
Brief 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.

Detailed Description
-----------------
The primary objective is the safety and tolerability of DS-5565 in Japanese subjects with moderate to severe renal impairment.

Official Title
-----------------
A JAPANESE, PHASE 3, OPEN-LABEL, 14-WEEK STUDY OF DS-5565 IN PATIENTS WITH PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY WITH RENAL IMPAIRMENT OR POST-HERPETIC NEURALGIA WITH RENAL IMPAIRMENT

Conditions
-----------------
Diabetic Peripheral Neuropathic Pain, Post-herpetic Neuralgia

Intervention / Treatment
-----------------
* Drug: DS-5565


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DS-5565 group<br>DS-5565 15 mg (for moderate renal impairment) or 7.5 mg (for severe renal impairment), oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose | Drug: DS-5565<br>* DS-5565 15 mg (for moderate renal impairment) or 7.5 mg (for severe renal impairment), oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose<br>* Other names: mirogabalin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Average Daily Pain Score (ADPS) at Each Week | Each participant recorded a pain score in the electronic patient diary once daily from the day after the screening visit (Visit 1) to the end of treatment/early termination visit (Visit 10). Prior to taking the study drug each morning, the participant selected the number that best described his or her pain over the past 24 hours on a scale of 0 (no pain) to 10 (worst possible pain). Higher ADPS scores indicated worse outcome. ADPS was the weekly average pain score based on the pain scores from the electronic patient diaries (Pain diary). In this outcome, the change from baseline in ADPS is being reported with negative values representing improvements in average daily pain. The larger the negative value (ie. improvement), the greater the improvement in average daily pain. | Baseline to Week 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic peripheral neuropathic pain, post-herpetic neuralgia, renal impairment