Diabetic Peripheral Neuropathic Pain
Conditions
Brief summary
Investigate the efficacy and safety of mirogabalin in Chinese participants with diabetic peripheral neuropathic pain in comparison to placebo.
Detailed 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.
Interventions
DRUGMirogabalin
Mirogabalin tablets for oral administration
DRUGPlacebo
Matching placebo tablets for oral administration
Sponsors
Daiichi Sankyo Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Daily Pain Score (ADPS) | Baseline to Week 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Score Using the Short-Form McGill Pain Questionnaire (SF-MPQ): Visual Analog Scale (VAS) | at Week 14 | The 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. |
| Patient Global Impression of Change | at Week 14 | 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. |
| Average Daily Sleep Interference score (ADSIS) | at Week 14 | 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. |
| ADPS responder rate | at Week 14 | 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. |
| Five Level EuroQol-5D (EQ-5D) version | at Week 14 | Participants rate their Quality of Life in the following dimensions: mobility (5-point scale), self-care (5-point scale), usual activities (5-point scale), pain/discomfort (5-point scale), and anxiety/depression(5-point scale) that are combined into an overall health utilities index. Participants also rate their perception of overall health using VAS, with zero indicating worst health and 100 representing best imaginable health. |
| Medical Outcome Study (MOS) sleep scale | at Week 14 | Participants rate their sleep quality during the past 4 weeks in three parts of the questionnaire: Part 1 - The participants rate the average time required to fall asleep, 0-15 minutes = 1, 16-30 minutes = 2, 31-45 minutes = 3, 46-60 minutes = 4, More than 60 minutes = 5. Part 2 - The participants give the number of hours per night for the average hours of sleep per night. Part 3 - The participants using a score of 1 (all of the time) to 5 (none of the time) to rate their sleep disturbance in the following areas: difficulty in falling asleep or remaining asleep, difficulty in staying awake during the day, difficulty in breathing, and snoring during sleep. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Actigraphy signal collected from a wrist-worn medical-grade sensor | at Week 14 | Result of physical activity during waking hours and participants' sleep will be evaluated to explore a relationship between participants reported outcomes and actigraphy signal collected from a wrist-worn medical-grade sensor (ActiGraph GT9X Link). Only participants who signed a separate informed consent form for wearing medical-grade sensor will be included in this evaluation. |
Countries
China
Outcome results
None listed