Exploratory Study of MT-8554 in Subjects With Painful Diabetic Peripheral Neuropathy

NCT05123196 | Completed Phase 2

• 2 other identifiers: MT-8554-A-201jRCT2051210097
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 33

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.

Conditions

Painful Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline and Week 12

Secondary Outcomes (11)

• 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 weekly mean nocturnal average NRS score 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

Study Arms (2)

MT-8554

EXPERIMENTAL

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

Drug: MT-8554

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MT-8554 DRUG

Oral Capsule

Also known as: Elismetrep

MT-8554

Placebo DRUG

Oral Capsule

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. Subjective symptoms\* thought to be due to diabetic polyneuropathy
• \. Decreased or eliminated bilateral Achilles tendon reflexes
• \. 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)
• Does not cause upper extremity symptoms alone
• Patients whose NRS during the run-in period is assessed for \>=4 days of the 7 days immediately before the first day of the treatment period and whose baseline 24-hour mean NRS score is \>=4 and =\<8.
• Patients whose rate of change in the 24-hour mean NRS score during the 7 days immediately before the first day of the treatment period is \<30%.
• Patients whose treatment for diabetes mellitus is consistent \>=8 weeks before the run-in period, who can consistently maintain the treatment throughout the study period, and in whom the investigator (or sub-investigator) can determine that glycemic control is constant.

You may not qualify if:

• 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.
• Patients with HbA1c \> 10.5%.
• Patients with poorly controlled hypertension (\>= 180 mmHg systolic and/or \>= 110 mmHg diastolic).
• Patients with eGFR \< 30 mL/min/1.73 m\^2.
• Patients with AST or ALT \> 2.5\*ULN.
• Patients who answered "Yes " to any item of Columbia Suicide Severity Rating Scale within the past 12 months.

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (33)

Yachiyo Hospital

Anjo, Aichi-ken, 446-8510, Japan

Location

Japan Organization of Occupational Health and Safety Chubu Rosai Hospital

Nagoya, Aichi-ken, 455-8530, Japan

Location

JUNEIKAI Medical Corporation Akaicho Clinic

Chiba, Chiba, 260-0804, Japan

Location

Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital

Fukuoka, Fukuoka, 811-0213, Japan

Location

TOJITAMA thyroid and diabetes Clinic

Fukuoka, Fukuoka, 815-0033, Japan

Location

Kunisaki Makoto Clinic

Fukuoka, Fukuoka, 819-0168, Japan

Location

Steel Memorial Yawata Hospital

Kitakyushu-shi, Fukuoka, 805-0050, Japan

Location

Medical Corporation Kouhoukai Takagi Hospital

Okawa-shi, Fukuoka, 831-0016, Japan

Location

Matsunami Health Promotion Clinic

Hashima-gun, Gifu, 501-6061, Japan

Location

Kikuchi Clinic of Internal Medicine

Maebashi, Gunma, 370-3573, Japan

Location

Japanese Red Cross Asahikawa Hospital

Asahikawa, Hokkaido, 070-8530, Japan

Location

Hakodate Central General Hospital

Hakodate, Hokkaido, 040-8585, Japan

Location

Jiyugaoka Yamada Internal Medicine Clinic

Obihiro, Hokkaido, 080-0848, Japan

Location

Sanuki Municipal Hospital

Sanuki-shi, Kagawa-ken, 769-2393, Japan

Location

Takamatsu Red Cross Hospital

Takamatsu, Kagawa-ken, 760-0017, Japan

Location

Shonan Fujisawa Tokushukai Hospital

Fujisawa-shi, Kanagawa, 251-0041, Japan

Location

Shunkaikai Inoue Hospital

Nagasaki, Nagasaki, 850-0045, Japan

Location

Medical Corporation Keiaikai Nakamura Hospital

Beppu, Oita Prefecture, 874-0937, Japan

Location

Medical Corporation Ikeikai Inobe Funai Clinic

Ōita, Oita Prefecture, 870-0021, Japan

Location

Abe Diabetes Clinic

Ōita, Oita Prefecture, 870-0039, Japan

Location

Saiki Central Hospital

Saiki, Oita Prefecture, 876-0851, Japan

Location

Medical Corporation Heishinkai OCROM Clinic

Suita, Osaka, 565-0853, Japan

Location

Hisatomi Clinic

Saga, Saga-ken, 849-0937, Japan

Location

Soka Sugiura Internal Medicine Clinic

Sōka, Saitama, 340-0034, Japan

Location

OMI MEDICAL CENTER, Social Medical Corporation Seikoukai

Kusatsu, Shiga, 525-8585, Japan

Location

Kumanomae Nishimura Naika Clinic

Arakawa-ku, Tokyo, 116-0012, Japan

Location

Tokyo Center Clinic

Chuo-ku, Tokyo, 103-0028, Japan

Location

Sugawara Clinic

Nerima-ku, Tokyo, 177-0041, Japan

Location

Ome Municipal General Hospital

Ome-shi, Tokyo, 198-0042, Japan

Location

Medical Corporation Souaikai Aihara Medical Clinic

Shinagawa-ku, Tokyo, 142-0053, Japan

Location

Medical Corporation Heishinkai ToCROM Clinic

Shinjuku-ku, Tokyo, 160-0008, Japan

Location

Japan Organization of Occupational Health and Safety Sanin Rosai Hospital

Yonago, Tottori, 683-8605, Japan

Location

Kitano Hospital, Tazuke Kofukai Medical Research Institute

Osaka, 530-8480, Japan

Location

Study Officials

• General Manager

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 17, 2021
• Study Start: November 16, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 8, 2022
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

JP (33)