Painful Diabetic Peripheral Neuropathy
Conditions
Brief summary
A Study to Investigate the Safety, Tolerability and Efficacy of Multiple Doses of MT-8554 in Subjects with Painful Diabetic Peripheral Neuropathy
Interventions
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male subjects and female subjects aged ≥18 years * Subjects who have a history of pain at least 6 months and ≤7 years attributed to diabetic peripheral neuropathy * A body mass index ranging from 18 to 45 kg/m2
Exclusion criteria
* Subjects who have participated in a clinical study of any IMP (other than placebo) within 12 weeks (from last administration) prior to screening or who are currently participation in another clinical study * Unstable or uncontrolled diabetes * Clinically significant 12-lead ECG abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability as measured by vital signs and Adverse Events | Up to Day 22 | Number of participants with potentially clinically important vital sign measurements or tolerability issues |
| Efficacy as measured by reduction in pain using a numerical rating scale. | Up to Day 49 | Pain reduction using an 11-point numerical rating scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with electrocardiogram (ECG) findings of potential clinical importance | Up to Day 49 | Number of participants with potentially clinically important ECG findings |
| Plasma concentration of MT-8554 | Up to Day 49 | Maximum Observed Plasma Concentration (Cmax) |
Countries
Germany, Hungary, Poland
Outcome results
None listed