DS-5565 phase 3 study for diabetic peripheral neuropathic pain

An Asian, phase 3, multicenter, randomized, double-blind, placebo-controlled 14-week study of DS-5565 in patients with diabetic peripheral neuropathic pain followed by a 52-week open-label extension

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222690

Enrollment

750

Registered

2014-12-11

Start date

2015-01-24

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

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: - Type 1 or type 2 diabetes mellitus - Painful distal symmetric polyneuropathy - Average daily pain score >= 4

Exclusion criteria

Exclusion criteria: - HbA1c > 10.0% - Uncontrolled blood glucose that may require changes in diabetes treatment (non-insulin drug therapy, exercise therapy, diet therapy) during study - Other severe pain unrelated to diabetic peripheral neuropathy, that may confound the assessment of diabetic peripheral neuropathic pain - Neurologic disorders unrelated to diabetic peripheral neuropathy, that may confound the assessment of diabetic peripheral neuropathic pain

Design outcomes

Primary

Measure	Time frame
efficacy confirmatory Average daily pain score	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics - Short-Form McGill Pain Questionnaire - Safety	—

Countries

Asia except Japan, Japan

Outcome results

None listed

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