Study of Mirogabalin for Central Neuropathic Pain

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

Detailed Description
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[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).

Official Title
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An Asian, Multicenter, Randomized, Double-blind, Placebo-controlled, 14-week Study of Mirogabalin in Participants With Central Neuropathic Pain Followed by a 52-week, Open-label Extension

Conditions
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Central Neuropathic Pain

Intervention / Treatment
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* Drug: Placebo
* Drug: Mirogabalin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: During the Double-blind Phase, participants will be randomized into parallel treatment arms. During the Open Extension Phase, all participants will be assigned to a single group.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirogabalin<br>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 | Drug: Mirogabalin<br>* Mirogabalin tablets for oral administration<br>* Other names: DS-5565;|
| Placebo Comparator: Placebo<br>Placebo (14-weeks) | Drug: Placebo<br>* Matching placebo tablets for oral administration<br>* Other names: Matching Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Daily Pain Score (ADPS) | The pain scores on a scale of 0-10, where 0 = no pain and 10 = the worst possible pain. The weekly ADPS is based on participants daily pain scores. | Baseline to Week 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Daily Pain Score (ADPS) Response Rate | Ratio of Participants Responding to Treatment, as Measured by Average Daily Pain Score (ADPS) Reduction from Baseline. The ADPS is used to determine categorical response rates. | at Week 14 | 
| Pain Intensity Score Using the Short-Form McGill Pain Questionnaire (SF-MPQ) | Participants rate their pain in three parts of the questionnaire, which are combined into a single pain intensity score: Part 1 - fifteen descriptors of pain intensity, on a scale of 0 (none) to 3 (severe) Part 2 - a VAS, in which the participant rates pain on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain Part 3 - a Present Pain Intensity index in which the participant rates present pain intensity on a scale of 0 (no pain) to 5 (most intense pain) | Baseline to Week 14 | 
| Patient Global Impression of Change | Participants rate their overall impression of how the present pain compares to baseline using a 7-point scale, where 1 = very much improved and 7 = very much worse. Patient Global Impression of Change scores are used to determine categorical responder rates. | at Week 14 | 
| Average Daily Sleep Interference score (ADSIS) | The sleep interference scores on a scale of 0-10, where 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep. The weekly ADSIS is based on participants daily sleep interference scores. | Baseline to Week 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Central neuropathic pain, Developmental phase III