Study of Mirogabalin for Central Neuropathic Pain

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Central Neuropathic Pain

Treatments: Drug: Mirogabalin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03901352

194653 (Registry Identifier)

DS5565-A-J314

Details and patient eligibility

About

Investigate the efficacy and safety of mirogabalin in participants with central neuropathic pain in comparison to placebo

Full description

[Double Blind Phase] The primary objective is to compare change in the Average Daily Pain Score (ADPS) from baseline to Week 14 in Asian participants with central neuropathic pain (central neuropathic pain after spinal cord injury) receiving mirogabalin versus placebo.

[Open Extension Phase] The objective is to assess the long-term safety and efficacy of mirogabalin in participants with central neuropathic pain (central neuropathic pain after spinal cord injury, central post stroke pain, and central neuropathic pain in Parkinson's disease).

Enrollment: 300 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Spinal cord injury (SCI) due to trauma
• American Spinal Injury Association impairment scale A, B, C, or D

Exclusion criteria

• Other severe pain at screening or randomization, unrelated to central neuropathic pain after SCI, that may confound the assessment of central neuropathic pain after SCI
• Neurologic disorders at screening or randomization, unrelated to central neuropathic pain after SCI, that may confound the assessment of central neuropathic pain after SCI
• Major psychiatric disorders within 1 year prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 2 patient groups, including a placebo group

Mirogabalin

Experimental group

Description:

The patients with creatinine clearance (CLcr) ≥ 60 mL/min: Mirogabalin 20 mg or 30 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks maintenance dose. The patients with creatinine clearance (CLcr) 30 to < 60 mL/min: Mirogabalin 10 mg or 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