A Phase 2 interventional study of MT-8554 low dose and MT-8554 middle dose in Painful Diabetic Peripheral Neuropathy, sponsored by Tanabe Pharma Corporation. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by Tanabe Pharma Corporation · Phase 2, Interventional, and Treatment
A Study to Investigate the Safety, Tolerability and Efficacy of Multiple Doses of MT-8554 in Subjects with Painful Diabetic Peripheral Neuropathy
Tanabe Pharma Corporation is the lead sponsor of 91 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who meet eligibility criteria will be administered twice daily low dose of MT-8554 during the treatment period.
Drug: MT-8554 low dose
Patients who meet eligibility criteria will be administered twice daily middle dose of MT-8554 during the treatment period.
Drug: MT-8554 middle dose
Patients who meet eligibility criteria will be administered twice daily high dose of MT-8554 during the treatment period.
Drug: MT-8554 high dose
The study participants will receive MT-8554 (TBD mg) in the first phase, followed by placebo in the second phase
Drug: MT-8554 low dose · Drug: MT-8554 middle dose · Drug: MT-8554 high dose · Drug: Placebo
The study participants will receive placebo in the first phase, followed by MT-8554 (TBD mg) in the second phase
Drug: MT-8554 low dose · Drug: MT-8554 middle dose · Drug: MT-8554 high dose · Drug: Placebo
Capsule
Capsule
Capsule
Capsule
Safety and Tolerability as measured by vital signs and Adverse Events
Number of participants with potentially clinically important vital sign measurements or tolerability issues
Time frame: Up to Day 22
Efficacy as measured by reduction in pain using a numerical rating scale.
Pain reduction using an 11-point numerical rating scale
Time frame: Up to Day 49
Number of subjects with electrocardiogram (ECG) findings of potential clinical importance
Number of participants with potentially clinically important ECG findings
Time frame: Up to Day 49
Plasma concentration of MT-8554
Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to Day 49
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tanabe Pharma Corporation