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

NCT ID: NCT05123196

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-16
• Study Completion Date: 2022-11-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MT-8554

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

Group Type: EXPERIMENTAL

MT-8554

Intervention Type: DRUG

Oral Capsule

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral Capsule

Interventions

MT-8554

Oral Capsule

Intervention Type: DRUG

Placebo

Oral Capsule

Intervention Type: DRUG

Other Intervention Names

Elismetrep

Eligibility Criteria

Inclusion Criteria

1. Patients with written consent

2. Patients aged >=20 years at the time of consent

3. Outpatients

4. 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)
• Does not cause upper extremity symptoms alone

5. 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.

6. 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%.

7. 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.

Exclusion Criteria

1. 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.

2. Patients who have had amputation of upper and lower limbs other than toes due to gangrene caused by impaired blood circulation.

3. Patients who do not meet the criteria of prohibited concomitant drugs or restricted concomitant drugs.

4. Patients with hypersensitivity to acetaminophen or a history of hypersensitivity to acetaminophen.

5. Patients with New York Heart Association functional class III or IV symptoms of heart failure.

6. History of myocardial infarction, congestive heart failure, unstable angina, or cerebrovascular disorder (excluding lacunar infarction) within 6 months prior to informed consent.

7. Patients with major psychiatric disorder such as depression or anxiety disorder.

8. Patients with drug abuse or a history of drug abuse.

9. 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.

10. Patients with HbA1c > 10.5%.

11. Patients with poorly controlled hypertension (>= 180 mmHg systolic and/or >= 110 mmHg diastolic).

12. Patients with eGFR < 30 mL/min/1.73 m^2.

13. Patients with AST or ALT > 2.5*ULN.

14. Patients who answered "Yes " to any item of Columbia Suicide Severity Rating Scale within the past 12 months.

15. Patients who have a concomitant malignancy or a history of malignancy. However, patients who have a history of malignancy but have not experienced recurrence for at least 5 years before informed consent (patients who have not experienced recurrence for at least 5 years after the last administration if the patients were receiving anticancer drugs) will be excluded.

16. Male or female patients of childbearing potential who do not agree to use contraception from the date of informed consent until 3 months after the completion (discontinuation) of investigational product.

17. Female patients who are pregnant, breastfeeding or possibly pregnant.

18. Patients who participated in another clinical study and received investigational product within 12 weeks before informed consent.

19. Prior exposure to MT-8554.

20. Other patients who, in the opinion of the investigator (or sub-investigator), are ineligible for this study.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanabe Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

General Manager

Role: STUDY_DIRECTOR

Tanabe Pharma Corporation

Locations

Yachiyo Hospital

Anjo, Aichi-ken, Japan

Japan Organization of Occupational Health and Safety Chubu Rosai Hospital

Nagoya, Aichi-ken, Japan

JUNEIKAI Medical Corporation Akaicho Clinic

Chiba, Chiba, Japan

Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital

Fukuoka, Fukuoka, Japan

TOJITAMA thyroid and diabetes Clinic

Fukuoka, Fukuoka, Japan

Kunisaki Makoto Clinic

Fukuoka, Fukuoka, Japan

Steel Memorial Yawata Hospital

Kitakyushu-shi, Fukuoka, Japan

Medical Corporation Kouhoukai Takagi Hospital

Okawa-shi, Fukuoka, Japan

Matsunami Health Promotion Clinic

Hashima-gun, Gifu, Japan

Kikuchi Clinic of Internal Medicine

Maebashi, Gunma, Japan

Japanese Red Cross Asahikawa Hospital

Asahikawa, Hokkaido, Japan

Hakodate Central General Hospital

Hakodate, Hokkaido, Japan

Jiyugaoka Yamada Internal Medicine Clinic

Obihiro, Hokkaido, Japan

Sanuki Municipal Hospital

Sanuki-shi, Kagawa-ken, Japan

Takamatsu Red Cross Hospital

Takamatsu, Kagawa-ken, Japan

Shonan Fujisawa Tokushukai Hospital

Fujisawa-shi, Kanagawa, Japan

Shunkaikai Inoue Hospital

Nagasaki, Nagasaki, Japan

Medical Corporation Keiaikai Nakamura Hospital

Beppu, Oita Prefecture, Japan

Medical Corporation Ikeikai Inobe Funai Clinic

Ōita, Oita Prefecture, Japan

Abe Diabetes Clinic

Ōita, Oita Prefecture, Japan

Saiki Central Hospital

Saiki, Oita Prefecture, Japan

Medical Corporation Heishinkai OCROM Clinic

Suita, Osaka, Japan

Hisatomi Clinic

Saga, Saga-ken, Japan

Soka Sugiura Internal Medicine Clinic

Sōka, Saitama, Japan

OMI MEDICAL CENTER, Social Medical Corporation Seikoukai

Kusatsu, Shiga, Japan

Kumanomae Nishimura Naika Clinic

Arakawa-ku, Tokyo, Japan

Tokyo Center Clinic

Chuo-ku, Tokyo, Japan

Sugawara Clinic

Nerima-ku, Tokyo, Japan

Ome Municipal General Hospital

Ome-shi, Tokyo, Japan

Medical Corporation Souaikai Aihara Medical Clinic

Shinagawa-ku, Tokyo, Japan

Medical Corporation Heishinkai ToCROM Clinic

Shinjuku-ku, Tokyo, Japan

Japan Organization of Occupational Health and Safety Sanin Rosai Hospital

Yonago, Tottori, Japan

Kitano Hospital, Tazuke Kofukai Medical Research Institute

Osaka, , Japan

Countries

Japan

Other Identifiers

jRCT2051210097

Identifier Type: REGISTRY

Identifier Source: secondary_id

MT-8554-A-201

Identifier Type: -

Identifier Source: org_study_id