Mirogabalin phase 3 study for central neuropathic pain

An Asian, multicenter, randomized, double-blind, placebo-controlled 14 week study of mirogabalin in patients with central 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-jRCT2080224584

Enrollment

274

Registered

2019-03-07

Start date

2019-03-12

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

central 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: - Spinal cord injury due to trauma - American Spinal Injury Association (ASIA) impairment scale A, B, C, or D

Exclusion criteria

Exclusion criteria: - Other severe pain at screening or randomization, unrelated to central neuropathic pain after spinal cord injury, that may confound the assessment of central neuropathic pain after spinal cord injury - Neurologic disorders at screening or randomization, unrelated to central neuropathic pain after spinal cord injury, that may confound the assessment of central neuropathic pain after spinal cord injury

Design outcomes

Primary

Measure	Time frame
efficacy Average daily pain score	—

Secondary

Measure	Time frame
safety efficacy - Short-Form McGill Pain Questionnaire - Average Daily Sleep Interference Score	—

Countries

Asia except Japan, Japan

Outcome results

None listed

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