A Randomized, Double-Blind, Placebo-Controlled, Exploratory Study of MT-8554 in Subjects With Painful Diabetic Peripheral Neuropathy

Tanabe Pharma Corporation33 sites in 1 country156 target enrollmentNovember 16, 2021

ConditionsPainful Diabetic Peripheral Neuropathy

InterventionsMT-8554 Placebo

DrugsMT-8554 Placebo

Overview

Phase: Phase 2
Intervention: MT-8554
Conditions: Painful Diabetic Peripheral Neuropathy
Sponsor: Tanabe Pharma Corporation
Enrollment: 156
Locations: 33
Primary Endpoint: Change from baseline in the weekly mean 24-hour average NRS score at Week 12 in treatment period
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to investigate the efficacy, safety, tolerability and pharmacokinetics of MT-8554, compared to placebo, in subjects with painful diabetic peripheral neuropathy.

Registry

clinicaltrials.gov

Start Date

November 16, 2021

End Date

November 8, 2022

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tanabe Pharma Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with written consent
•Patients aged \>=20 years at the time of consent
•Outpatients
•Patients with pain associated with peripheral symmetric polyneuropathy due to diabetes mellitus and pain lasting \>=3 months on the first day of the run-in period. The patient should meet \>=2 of the following criteria or nerve conduction studies showing abnormalities in at least one test item (Conduction velocity, amplitude, and latency) for at least two nerves by the first day of run-in period.
•1\. Subjective symptoms\* thought to be due to diabetic polyneuropathy
•2\. Decreased or eliminated bilateral Achilles tendon reflexes
•3\. Bilateral decreased vibratory sense of the medial malleolus (=\< 10 seconds with a C 128 tuning fork)
•\*Subjective symptoms thought to be due to diabetic neuropathy meet the following 3 criteria.
•Bilateral
•Toe and plantar symptoms (Numbness, pain or dysesthesia)

Exclusion Criteria

•Patients with pain, disease, or skin condition that, in the opinion of the investigator (or sub-investigator), would influence the evaluation of painful diabetic peripheral neuropathy.
•For example, if other pain is in the same location as painful diabetic peripheral neuropathy, or if the pain intensity of the other pain is greater than that of painful diabetic peripheral neuropathy, which in the opinion of the investigator (or sub-investigator) would impact the assessment of painful diabetic peripheral neuropathy.
•Patients who have had amputation of upper and lower limbs other than toes due to gangrene caused by impaired blood circulation.
•Patients who do not meet the criteria of prohibited concomitant drugs or restricted concomitant drugs.
•Patients with hypersensitivity to acetaminophen or a history of hypersensitivity to acetaminophen.
•Patients with New York Heart Association functional class III or IV symptoms of heart failure.
•History of myocardial infarction, congestive heart failure, unstable angina, or cerebrovascular disorder (excluding lacunar infarction) within 6 months prior to informed consent.
•Patients with major psychiatric disorder such as depression or anxiety disorder.
•Patients with drug abuse or a history of drug abuse.
•Patients with current or previous infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). However, patients with previous infection with hepatitis B virus who are HBsAg-negative are eligible.

Arms & Interventions

MT-8554

MT-8554 will be started from a low dose, and gradually increase the dose in order.

Intervention: MT-8554

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Change from baseline in the weekly mean 24-hour average NRS score at Week 12 in treatment period

Time Frame: Baseline and Week 12

Numeric Rating Scale (NRS) is the 11-point numerical rating scale of 0 (no pain) to 10 (worst possible pain). Higher NRS scores indicated worse outcome.

Secondary Outcomes

Change from baseline in weekly mean nocturnal average NRS score at each assessment point(Up to Week 12)
Proportion of PGIC responders at each assessment point(Up to Week 12)
Change from baseline in weekly mean 24 hour worst NRS score at each assessment point(Up to Week 12)
Change from baseline in BPI functional impairment at each assessment point(Up to Week 12)
Change from baseline in weekly mean 24-hour average NRS score at each assessment point(Up to Week 12)
Average weekly 24-hour NRS score during the 12 week treatment period 30% and 50% responder rates(Baseline and Week 12)
Change from baseline in weekly mean daily NRS score at each assessment point(Up to Week 12)
Change from baseline in NPSI at each assessment point(Up to Week 12)
Change from baseline in BPI pain severity at each assessment point(Up to Week 12)
Change from baseline in MOS-SS at each assessment point(Up to Week 12)
Proportion of CGIC responder at each assessment point(Up to Week 12)