DS-5565 phase 2 study

An Asian, phase 2, multicenter, randomized, double-blind, placebo- and pregabalin-controlled, dose-finding study of DS-5565 in patients with pain associated with diabetic peripheral neuropathy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221671

Enrollment

400

Registered

2011-12-13

Start date

2012-01-27

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

Pain associated with diabetic peripheral neuropathy

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 (National Glycohemoglobin Standardization Program) > 9.0%

Design outcomes

Primary

Measure	Time frame
efficacy exploratory Average daily pain score	—

Secondary

Measure	Time frame
safety efficacy exploratory - 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