Study to Assess the Efficacy, Safety and Tolerability of MT- 8554 in Subjects With Painful Diabetic Peripheral Neuropathy
Painful Diabetic Peripheral Neuropathy
About this trial
This is an interventional treatment trial for Painful Diabetic Peripheral Neuropathy
Eligibility Criteria
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
Sites / Locations
- Investigational center
- Investigational center
- Investigational center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
MT-8554 low dose
MT-8554 middle dose
MT-8554 high dose
MT-8554, then placebo
Placebo, then MT-8554
Patients who meet eligibility criteria will be administered twice daily low dose of MT-8554 during the treatment period.
Patients who meet eligibility criteria will be administered twice daily middle dose of MT-8554 during the treatment period.
Patients who meet eligibility criteria will be administered twice daily high dose of MT-8554 during the treatment period.
The study participants will receive MT-8554 (TBD mg) in the first phase, followed by placebo in the second phase
The study participants will receive placebo in the first phase, followed by MT-8554 (TBD mg) in the second phase