DS-5565 phase 3 study for renal impairment

A Japanese, phase 3, open-label, 14-week study of DS-5565 in patients with pain associated with diabetic peripheral neuropathy (DPNP) with renal impairment or post-herpetic neuralgia (PHN) with renal impairment

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223005

Enrollment

Registered

2015-11-06

Start date

2016-01-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic peripheral neuropathic pain, Post-herpetic neuralgia

Interventions

investigational material(s) Generic name etc : DS-5565 INN of investigational material : Mirogabalin Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with DPNP and patients with PHN: -Average daily pain score >= 4 -Creatinine clearance (using Cockcroft-Gault equation): 15-59 mL/min at screening Patients with DPNP only: -Type 1 or Type 2 diabetes mellitus -Painful distal symmetric polyneuropathy Patients with PHN only: -Post-herpetic neuralgia defined as pain present for more than 3 months after herpes zoster skin rash

Exclusion criteria

Exclusion criteria: For patients with DPNP only: -HbA1c > 10.0% -Uncontrolled blood glucose at screening at initiation of study treatment that may require changes in diabetes treatment (non-insulin drug therapy, exercise therapy, diet therapy) during the study -Other severe pain at screening or initiation of study treatment, unrelated to diabetic peripheral neuropathy (DPN), that may confound the assessment of DPNP -Neurologic disorders at screening or initiation of study treatment, unrelated to DPN, that may confound the assessment of DPNP For patients with PHN only: -Previous use of neurolytic block (eg, chemical neurolytic block using phenol or ethyl alcohol, radiofrequency thermocoagulation) or neurosurgical therapy for current PHN -Other severe pain at screening or initiation of study treatment, unrelated to PHN, that may confound the assessment of PHN -Neurologic disorders at screening or initiation of study treatment, unrelated to PHN, that may confound the assessment of PHN

Design outcomes

Primary

Measure	Time frame
safety safety and tolerability	—

Secondary

Measure	Time frame
efficacy pharmacokinetics Average Daily Pain Score	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026