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

NCT03172598 | Completed Phase 2

• 1 other identifier: MT-8554-E06
• Study Type: interventional
• Target: 61
• Locations: 3 countries
• Sites: 3

Brief Summary

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

Conditions

Painful Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability as measured by vital signs and Adverse Events

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

  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

  Up to Day 49

Secondary Outcomes (2)

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

  Up to Day 49

• Plasma concentration of MT-8554

  Up to Day 49

Study Arms (5)

MT-8554 low dose

EXPERIMENTAL

Patients who meet eligibility criteria will be administered twice daily low dose of MT-8554 during the treatment period.

Drug: MT-8554 low dose

MT-8554 middle dose

EXPERIMENTAL

Patients who meet eligibility criteria will be administered twice daily middle dose of MT-8554 during the treatment period.

Drug: MT-8554 middle dose

MT-8554 high dose

EXPERIMENTAL

Patients who meet eligibility criteria will be administered twice daily high dose of MT-8554 during the treatment period.

Drug: MT-8554 high dose

MT-8554, then placebo

EXPERIMENTAL

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

Placebo, then MT-8554

EXPERIMENTAL

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

Interventions

MT-8554 low dose DRUG

Capsule

MT-8554 low dose; MT-8554, then placebo; Placebo, then MT-8554

MT-8554 middle dose DRUG

Capsule

MT-8554 middle dose; MT-8554, then placebo; Placebo, then MT-8554

MT-8554 high dose DRUG

Capsule

MT-8554 high dose; MT-8554, then placebo; Placebo, then MT-8554

Placebo DRUG

Capsule

MT-8554, then placebo; Placebo, then MT-8554

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (3)

Investigational center

City Name, Germany

Location

Investigational center

City Name, Hungary

Location

Investigational center

City Name, Poland

Location

Study Officials

• General Manager

  Tanabe Pharma Europe Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: June 1, 2017
• Study Start: July 25, 2017
• Primary Completion: August 8, 2018
• Study Completion: August 8, 2018
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

PL (1); DE (1); HU (1)