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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03172598
• Date of registration: 29/05/2017
• Prospective Registration: Yes
• Primary sponsor: Mitsubishi Tanabe Pharma Corporation
• Public title: Study to Assess the Efficacy, Safety and Tolerability of MT- 8554 in Subjects With Painful Diabetic Peripheral Neuropathy
• Scientific 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
• Date of first enrolment: July 25, 2017
• Target sample size: 61
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03172598
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Germany, Hungary, Poland

Contacts

• Name: General Manager
• Affiliation: Mitsubishi Tanabe Pharma Europe Ltd

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Painful Diabetic Peripheral Neuropathy

Intervention(s)

Drug: MT-8554 middle dose

Drug: Placebo

Drug: MT-8554 low dose

Drug: MT-8554 high dose

Primary Outcome(s)

Efficacy as measured by reduction in pain using a numerical rating scale. [Time Frame: Up to Day 49]

Safety and Tolerability as measured by vital signs and Adverse Events [Time Frame: Up to Day 22]

Secondary Outcome(s)

Number of subjects with electrocardiogram (ECG) findings of potential clinical importance [Time Frame: Up to Day 49]

Plasma concentration of MT-8554 [Time Frame: Up to Day 49]

Secondary ID(s)

MT-8554-E06

Source(s) of Monetary Support

Please refer to primary and secondary sponsors