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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
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

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

Experimental

Experimental

Experimental

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

First Posted
May 29, 2017
Last Updated
August 23, 2018
Sponsor
Mitsubishi Tanabe Pharma Corporation
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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
No
Studies a U.S. FDA-regulated Device Product
No

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
No
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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