The hypothesis of this Phase 2 study is that at least 1 dose regimen of DS-1971a will demonstrate clinical superiority to placebo in managing pain associated with DPNP, and will be generally well tolerated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Change in weekly Average Daily Pain Score (ADPS)
Time frame: week 0 (Baseline) to Week 7
Response rate, proportion of subjects with ≥ 30% or ≥ 50% reduction
Response rate, defined as the proportion of subjects with ≥ 30% or ≥ 50% reduction
Time frame: week 0 (Baseline) to Week 7
Effect of DS-1971a on Patient Global Impression of Change (PGIC) in neuropathic pain
Effect of DS-1971a on Patient Global Impression of Change (PGIC) in neuropathic pain
Time frame: week 7
Effect of DS-1971a on pain intensity and severity
Effect of DS-1971a on pain intensity and severity as assessed by the Short-Form McGill Pain Questionnaire (SF-MPQ)
Time frame: week 7
Effect of DS-1971a on pain intensity and severity
Effect of DS-1971a on pain interference with daily activities as assessed by a modified Brief Pain Inventory Short Form (BPI-SF)
Time frame: week 7
Change in Hospital Anxiety and Depression Scale (HADS)
Change as assessed by the Hospital Anxiety and Depression Scale (HADS)
Time frame: week 0 (Baseline) to Week 7
Change in pain-associated sleep interference score (ADSIS)
Change in pain-associated sleep interference as assessed by average daily sleep interference score (ADSIS)
Time frame: week 0 (Baseline) to Week 7
Changes in subject general health status
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Changes in subject general health status as assessed by the Short Form 36 (SF-36) questionnaire
Time frame: week 0 (Baseline) to Week 7
number and severity of Adverse Events (AEs), clinical laboratory abnormalities, physical examinations, ECGs, vital signs
number and severity of AEs, clinical laboratory abnormalities, physical examinations, 12-lead electrocardiograms (ECGs), and vital signs
Time frame: week 0 (Baseline) to Week 7
change in Columbia-Suicide Severity Rating Scale (C SSRS)
change in Columbia-Suicide Severity Rating Scale (C SSRS)
Time frame: week 0 (Baseline) to Week 7
Effects of treatments on neuropathic pain components
Effects of treatments on neuropathic pain components assessed with the Neuropathic Pain Symptom Inventory (NPSI)
Time frame: week 7
change in weekly ADPS responder rate
Effects of DS-1971a versus pregabalin (titrated to 300 mg daily) in weekly ADPS responder rate at Week 7
Time frame: week 7
Rescue medication usage
Rate of rescue medication usage
Time frame: week 0 through week 7