The purpose of this study is to investigate the efficacy, safety, tolerability and pharmacokinetics of MT-8554, compared to placebo, in subjects with painful diabetic peripheral neuropathy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
156
Change from baseline in the weekly mean 24-hour average NRS score at Week 12 in treatment period
Numeric Rating Scale (NRS) is the 11-point numerical rating scale of 0 (no pain) to 10 (worst possible pain). Higher NRS scores indicated worse outcome.
Time frame: Baseline and Week 12
Change from baseline in weekly mean 24-hour average NRS score at each assessment point
Numeric Rating Scale (NRS) is the 11-point numerical rating scale of 0 (no pain) to 10 (worst possible pain). Higher NRS scores indicated worse outcome.
Time frame: Up to Week 12
Average weekly 24-hour NRS score during the 12 week treatment period 30% and 50% responder rates
Numeric Rating Scale (NRS) is the 11-point numerical rating scale of 0 (no pain) to 10 (worst possible pain). Higher NRS scores indicated worse outcome.
Time frame: Baseline and Week 12
Change from baseline in weekly mean daily NRS score at each assessment point
Numeric Rating Scale (NRS) is the 11-point numerical rating scale of 0 (no pain) to 10 (worst possible pain). Higher NRS scores indicated worse outcome.
Time frame: Up to Week 12
Change from baseline in weekly mean nocturnal average NRS score at each assessment point
Numeric Rating Scale (NRS) is the 11-point numerical rating scale of 0 (no pain) to 10 (worst possible pain). Higher NRS scores indicated worse outcome.
Time frame: Up to Week 12
Change from baseline in weekly mean 24 hour worst NRS score at each assessment point
Numeric Rating Scale (NRS) is the 11-point numerical rating scale of 0 (no pain) to 10 (worst possible pain). Higher NRS scores indicated worse outcome.
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Yachiyo Hospital
Anjo, Aichi-ken, Japan
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital
Nagoya, Aichi-ken, Japan
JUNEIKAI Medical Corporation Akaicho Clinic
Chiba, Chiba, Japan
Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital
Fukuoka, Fukuoka, Japan
TOJITAMA thyroid and diabetes Clinic
Fukuoka, Fukuoka, Japan
Kunisaki Makoto Clinic
Fukuoka, Fukuoka, Japan
Steel Memorial Yawata Hospital
Kitakyushu-shi, Fukuoka, Japan
Medical Corporation Kouhoukai Takagi Hospital
Okawa-shi, Fukuoka, Japan
Matsunami Health Promotion Clinic
Hashima-gun, Gifu, Japan
Kikuchi Clinic of Internal Medicine
Maebashi, Gunma, Japan
...and 23 more locations
Time frame: Up to Week 12
Change from baseline in NPSI at each assessment point
Neuropathic Pain Symptom Inventory (NPSI) is the questionnaire to evaluate the different symptoms of neuropathic pain and each symptoms are evaluated from 0 (no pain) to 10 (worst possible pain). Higher NPSI scores indicated worse outcome.
Time frame: Up to Week 12
Change from baseline in BPI pain severity at each assessment point
Brief Pain Inventory (BPI) is the questionnaire to assess the severity of pain from 0 (no pain) to 10 (pain as bad as patient can imagine). Higher BPI scores indicated worse outcome.
Time frame: Up to Week 12
Change from baseline in BPI functional impairment at each assessment point
Brief Pain Inventory (BPI) is the questionnaire to assess the impact of pain on daily functions from 0 (does not interfere) to 10 (completely interferes). Higher BPI scores indicated worse outcome.
Time frame: Up to Week 12
Change from baseline in MOS-SS at each assessment point
Medical Outcomes Study-Sleep Scale (MOS-SS) is the questionnaire to evaluate the "sleep disorder " "snoring" "sleep arousal with shortness of breath or headache" "sleep sufficiency" "somnolence" and "amount of sleep/optimal sleep" ranges from 0 (all of the time) to 6 (none of the time). Lower MOS-SS scores indicated worse outcome.
Time frame: Up to Week 12
Proportion of PGIC responders at each assessment point
Patient Global Impression of Change (PGIC) is a questionnaire to evaluate the overall impression of pain improvement by patient from 1 (very much improved) to 7 (very much worse). Higher PGIC scores indicated worse outcome.
Time frame: Up to Week 12
Proportion of CGIC responder at each assessment point
Clinician Global Impression of Change (CGIC) a questionnaire to evaluate the overall impression of pain improvement by clinician from 1 (very much improved) to 7 (very much worse). Higher CGIC scores indicated worse outcome.
Time frame: Up to Week 12