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New pill could ease diabetic nerve pain

NCT ID NCT05123196

Symptom relief Sponsor: Tanabe Pharma Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a drug called MT-8554 (Elismetrep) in 156 adults with painful diabetic peripheral neuropathy. The goal was to see if it reduces pain better than a placebo over 12 weeks. Participants took either the drug or a placebo capsule, and pain was measured using a 0-10 scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MT-8554 (Elismetrep) oral capsule
What this could lead to
If it works, this could lead to a new pain relief option for people with diabetic nerve pain.
What could go wrong
This is an early Phase 2 trial with only 156 participants, so results may not apply to everyone. The drug may not reduce pain better than a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

156 people

The number who actually took part.

Started

Nov 2021

Finished

Nov 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

diabetic neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Painful diabetic peripheral neuropathy

Contacts and locations

Locations

  • Abe Diabetes Clinic

    Ōita, Oita Prefecture, 870-0039, Japan

  • Hakodate Central General Hospital

    Hakodate, Hokkaido, 040-8585, Japan

  • Hisatomi Clinic

    Saga, Saga-ken, 849-0937, Japan

  • JUNEIKAI Medical Corporation Akaicho Clinic

    Chiba, Chiba, 260-0804, Japan

  • Japan Organization of Occupational Health and Safety Chubu Rosai Hospital

    Nagoya, Aichi-ken, 455-8530, Japan

  • Japan Organization of Occupational Health and Safety Sanin Rosai Hospital

    Yonago, Tottori, 683-8605, Japan

  • Japanese Red Cross Asahikawa Hospital

    Asahikawa, Hokkaido, 070-8530, Japan

  • Jiyugaoka Yamada Internal Medicine Clinic

    Obihiro, Hokkaido, 080-0848, Japan

  • Kikuchi Clinic of Internal Medicine

    Maebashi, Gunma, 370-3573, Japan

  • Kitano Hospital, Tazuke Kofukai Medical Research Institute

    Osaka, 530-8480, Japan

  • Kumanomae Nishimura Naika Clinic

    Arakawa-ku, Tokyo, 116-0012, Japan

  • Kunisaki Makoto Clinic

    Fukuoka, Fukuoka, 819-0168, Japan

  • Matsunami Health Promotion Clinic

    Hashima-gun, Gifu, 501-6061, Japan

  • Medical Corporation Heishinkai OCROM Clinic

    Suita, Osaka, 565-0853, Japan

  • Medical Corporation Heishinkai ToCROM Clinic

    Shinjuku-ku, Tokyo, 160-0008, Japan

  • Medical Corporation Ikeikai Inobe Funai Clinic

    Ōita, Oita Prefecture, 870-0021, Japan

  • Medical Corporation Keiaikai Nakamura Hospital

    Beppu, Oita Prefecture, 874-0937, Japan

  • Medical Corporation Kouhoukai Takagi Hospital

    Okawa-shi, Fukuoka, 831-0016, Japan

  • Medical Corporation Souaikai Aihara Medical Clinic

    Shinagawa-ku, Tokyo, 142-0053, Japan

  • OMI MEDICAL CENTER, Social Medical Corporation Seikoukai

    Kusatsu, Shiga, 525-8585, Japan

  • Ome Municipal General Hospital

    Ome-shi, Tokyo, 198-0042, Japan

  • Saiki Central Hospital

    Saiki, Oita Prefecture, 876-0851, Japan

  • Sanuki Municipal Hospital

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

  • Shonan Fujisawa Tokushukai Hospital

    Fujisawa-shi, Kanagawa, 251-0041, Japan

  • Shunkaikai Inoue Hospital

    Nagasaki, Nagasaki, 850-0045, Japan

  • Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital

    Fukuoka, Fukuoka, 811-0213, Japan

  • Soka Sugiura Internal Medicine Clinic

    Sōka, Saitama, 340-0034, Japan

  • Steel Memorial Yawata Hospital

    Kitakyushu-shi, Fukuoka, 805-0050, Japan

  • Sugawara Clinic

    Nerima-ku, Tokyo, 177-0041, Japan

  • TOJITAMA thyroid and diabetes Clinic

    Fukuoka, Fukuoka, 815-0033, Japan

  • Takamatsu Red Cross Hospital

    Takamatsu, Kagawa-ken, 760-0017, Japan

  • Tokyo Center Clinic

    Chuo-ku, Tokyo, 103-0028, Japan

  • Yachiyo Hospital

    Anjo, Aichi-ken, 446-8510, Japan

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