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

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

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

Study Overview

• Status: Completed
• Conditions: Painful Diabetic Peripheral Neuropathy
• Intervention / Treatment: Drug: Placebo; Drug: MT-8554 low dose; Drug: MT-8554 middle dose; Drug: MT-8554 high dose

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • City Name, Germany
    • Investigational center
• Hungary
  • City Name, Hungary
    • Investigational center
• Poland
  • City Name, Poland
    • Investigational center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MT-8554 low dose; Patients who meet eligibility criteria will be administered twice daily low dose of MT-8554 during the treatment period.	Drug: MT-8554 low dose; Capsule
Experimental: MT-8554 middle 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; Capsule
Experimental: MT-8554 high 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; Capsule
Experimental: MT-8554, then placebo; The study participants will receive MT-8554 (TBD mg) in the first phase, followed by placebo in the second phase	Drug: Placebo; Capsule; Drug: MT-8554 low dose; Capsule; Drug: MT-8554 middle dose; Capsule; Drug: MT-8554 high dose; Capsule
Experimental: Placebo, then MT-8554; The study participants will receive placebo in the first phase, followed by MT-8554 (TBD mg) in the second phase	Drug: Placebo; Capsule; Drug: MT-8554 low dose; Capsule; Drug: MT-8554 middle dose; Capsule; Drug: MT-8554 high dose; Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with electrocardiogram (ECG) findings of potential clinical importance	Number of participants with potentially clinically important ECG findings	Up to Day 49
Plasma concentration of MT-8554	Maximum Observed Plasma Concentration (Cmax)	Up to Day 49

Collaborators and Investigators

• Sponsor: Mitsubishi Tanabe Pharma Corporation

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2017
• Primary Completion (Actual): August 8, 2018
• Study Completion (Actual): August 8, 2018

Study Registration Dates

• First Submitted: May 29, 2017
• First Submitted That Met QC Criteria: May 31, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Actual): August 27, 2018
• Last Update Submitted That Met QC Criteria: August 23, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pain; Diabetic Neuropathies
• Other Study ID Numbers: MT-8554-E06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No