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

Primary Purpose

Painful Diabetic Peripheral Neuropathy

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

MT-8554 low dose

MT-8554 middle dose

MT-8554 high dose

Placebo

About this trial

This is an interventional treatment trial for Painful Diabetic Peripheral Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

MT-8554 low dose

MT-8554 middle dose

MT-8554 high dose

MT-8554, then placebo

Placebo, then MT-8554

Arm Description

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

Outcomes

Primary Outcome Measures

Safety and Tolerability as measured by vital signs and Adverse Events

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.

Pain reduction using an 11-point numerical rating scale

Secondary Outcome Measures

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

Number of participants with potentially clinically important ECG findings

Plasma concentration of MT-8554

Maximum Observed Plasma Concentration (Cmax)

Full Information

NCT ID

NCT03172598

First Posted

May 29, 2017

Last Updated

August 23, 2018

Sponsor

Mitsubishi Tanabe Pharma Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03172598

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

July 25, 2017 (Actual)

Primary Completion Date

August 8, 2018 (Actual)

Study Completion Date

August 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mitsubishi Tanabe Pharma Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Painful Diabetic Peripheral Neuropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MT-8554 low dose

Arm Type

Experimental

Arm Description

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

Arm Title

MT-8554 middle dose

Arm Type

Experimental

Arm Description

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

Arm Title

MT-8554 high dose

Arm Type

Experimental

Arm Description

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

Arm Title

MT-8554, then placebo

Arm Type

Experimental

Arm Description

The study participants will receive MT-8554 (TBD mg) in the first phase, followed by placebo in the second phase

Arm Title

Placebo, then MT-8554

Arm Type

Experimental

Arm Description

The study participants will receive placebo in the first phase, followed by MT-8554 (TBD mg) in the second phase

Intervention Type

Drug

Intervention Name(s)

MT-8554 low dose

Intervention Description

Capsule

Intervention Type

Drug

Intervention Name(s)

MT-8554 middle dose

Intervention Description

Capsule

Intervention Type

Drug

Intervention Name(s)

MT-8554 high dose

Intervention Description

Capsule

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Capsule

Primary Outcome Measure Information:

Title

Safety and Tolerability as measured by vital signs and Adverse Events

Description

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

Time Frame

Up to Day 22

Title

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

Description

Pain reduction using an 11-point numerical rating scale

Time Frame

Up to Day 49

Secondary Outcome Measure Information:

Title

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

Description

Number of participants with potentially clinically important ECG findings

Time Frame

Up to Day 49

Title

Plasma concentration of MT-8554

Description

Maximum Observed Plasma Concentration (Cmax)

Time Frame

Up to Day 49

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

General Manager

Organizational Affiliation

Mitsubishi Tanabe Pharma Europe Ltd

Official's Role

Study Director

Facility Information:

Facility Name

Investigational center

City

City Name

Country

Germany

Facility Name

Investigational center

City

City Name

Country

Hungary

Facility Name

Investigational center

City

City Name

Country

Poland

12. IPD Sharing Statement

Learn more about this trial

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

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