A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain

• Status: Active, not recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

Summary

Investigate the efficacy and safety of mirogabalin in Chinese participants with diabetic peripheral neuropathic pain in comparison to placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.

Criteria

Inclusion Criteria:

• Type 1 or type 2 diabetes mellitus at screening

• Painful distal symmetric polyneuropathy, diagnosed at least 6 months prior to screening (see Procedures manual for the Diagnosis of Diabetic Peripheral Neuropathy and Neurological Examination for details)

Exclusion Criteria:

• HbA1c (National Glycohemoglobin Standardization Program) > 10.0% at screening

• Uncontrolled blood glucose within 1 month prior to screening, at screening or randomization

• Other severe pain at screening or randomization, unrelated to DPN, that may confound the assessment of DPNP

• Neurologic disorders at screening or randomization, unrelated to DPN, that may confound the assessment of DPNP

• Major psychiatric disorders at screening or randomization

• Creatinine clearance (using the Cockcroft-Gault equation) < 60 mL/min at screening