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

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Diabetic Peripheral Neuropathic Pain

Treatments: Drug: Mirogabalin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04094662

DS5565-A-A315

Details and patient eligibility

About

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

Full description

The primary objective is to compare change from baseline in weekly Average Daily Pain Score (ADPS) at Week 14 in Chinese patients with Diabetic Peripheral Neuropathic Pain (DPNP) receiving mirogabalin versus placebo.

Enrollment: 393 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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393 participants in 2 patient groups, including a placebo group

Mirogabalin

Experimental group

Description:

Mirogabalin 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks maintenance dose.

Treatment:

Drug: Mirogabalin

Placebo

Placebo Comparator group

Description:

Placebo (14-weeks)

Treatment:

Drug: Placebo