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Completed

NCT Number: NCT03172598

Study to Assess the Efficacy, Safety and Tolerability of MT- 8554 in Subjects With Painful Diabetic Peripheral Neuropathy

A Study to Investigate the Safety, Tolerability and Efficacy of Multiple Doses of MT-8554 in Subjects with Painful Diabetic Peripheral Neuropathy

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Key information

Conditions

Painful Diabetic Peripheral Neuropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational center, City Name, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MT-8554 Low dose

Drug

Capsule

MT-8554 middle dose

Drug

Capsule

MT-8554 High dose

Drug

Capsule

Placebo

Drug

Capsule

Primary outcomes

  1. Safety and Tolerability as measured by vital signs and Adverse Events

    Time frame: Up to Day 22

    Number of participants with potentially clinically important vital sign measurements or tolerability issues

  2. Efficacy as measured by reduction in pain using a numerical rating scale.

    Time frame: Up to Day 49

    Pain reduction using an 11-point numerical rating scale

Secondary outcomes

  1. Number of subjects with electrocardiogram (ECG) findings of potential clinical importance

    Time frame: Up to Day 49

    Number of participants with potentially clinically important ECG findings

  2. Plasma concentration of MT-8554

    Time frame: Up to Day 49

    Maximum Observed Plasma Concentration (Cmax)

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

A Phase IIa, Multi-Centre, Randomised, Double-Blind, Cross-Over, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of MT-8554 in Subjects With Painful Diabetic Peripheral Neuropathy Incorporating an Open Label Pilot Arm

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 1, 2017
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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