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

Painful Diabetic Peripheral Neuropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03172598
• Other study ID #: MT-8554-E06
• Status: Completed
• Phase: Phase 2
• Start date: July 25, 2017
• Est. completion date: August 8, 2018

Study information

• Verified date: August 2018
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: August 8, 2018
• Est. primary completion date: August 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Pain
• Painful Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Drug:
• MT-8554 low dose
Capsule
• MT-8554 middle dose
Capsule
• MT-8554 high dose
Capsule
• Placebo
Capsule

Locations

Country	Name	City	State
Germany	Investigational center	City Name
Hungary	Investigational center	City Name
Poland	Investigational center	City Name

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Countries where clinical trial is conducted

Germany,  Hungary,  Poland, 

Outcome

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