Painful Diabetic Peripheral NeuropathyPhase 2NCT05123196
Exploratory Study of MT-8554 in Subjects With Painful Diabetic Peripheral Neuropathy
A Phase 2 study testing MT-8554 in people with Painful Diabetic Peripheral Neuropathy, run by Tanabe Pharma Corporation at 33 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Painful Diabetic Peripheral Neuropathy
- What is being tested?
- MT-8554
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 33 sitesJapan
- Study dates
- 16 Nov 2021to 8 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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.
Who cannot join
- 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.
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- 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.
- 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.
- 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.
- Female patients who are pregnant, breastfeeding or possibly pregnant.
- Patients who participated in another clinical study and received investigational product within 12 weeks before informed consent.
- Prior exposure to MT-8554.
- Other patients who, in the opinion of the investigator (or sub-investigator), are ineligible for this study.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
Japan33 sites
Yachiyo Hospital
Anjo, Aichi-ken, 446-8510
Kumanomae Nishimura Naika Clinic
Arakawa-ku, Tokyo, 116-0012
Japanese Red Cross Asahikawa Hospital
Asahikawa, Hokkaido, 070-8530
Medical Corporation Keiaikai Nakamura Hospital
Beppu, Oita Prefecture, 874-0937
JUNEIKAI Medical Corporation Akaicho Clinic
Chiba, Chiba, 260-0804
Tokyo Center Clinic
Chuo-ku, Tokyo, 103-0028
Shonan Fujisawa Tokushukai Hospital
Fujisawa-shi, Kanagawa, 251-0041
Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital
Fukuoka, Fukuoka, 811-0213
TOJITAMA thyroid and diabetes Clinic
Fukuoka, Fukuoka, 815-0033
Kunisaki Makoto Clinic
Fukuoka, Fukuoka, 819-0168
Hakodate Central General Hospital
Hakodate, Hokkaido, 040-8585
Matsunami Health Promotion Clinic
Hashima-gun, Gifu, 501-6061
Steel Memorial Yawata Hospital
Kitakyushu-shi, Fukuoka, 805-0050
OMI MEDICAL CENTER, Social Medical Corporation Seikoukai
Kusatsu, Shiga, 525-8585
Kikuchi Clinic of Internal Medicine
Maebashi, Gunma, 370-3573
Shunkaikai Inoue Hospital
Nagasaki, Nagasaki, 850-0045
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital
Nagoya, Aichi-ken, 455-8530
Sugawara Clinic
Nerima-ku, Tokyo, 177-0041
Jiyugaoka Yamada Internal Medicine Clinic
Obihiro, Hokkaido, 080-0848
Medical Corporation Ikeikai Inobe Funai Clinic
Ōita, Oita Prefecture, 870-0021
Abe Diabetes Clinic
Ōita, Oita Prefecture, 870-0039
Medical Corporation Kouhoukai Takagi Hospital
Okawa-shi, Fukuoka, 831-0016
Ome Municipal General Hospital
Ome-shi, Tokyo, 198-0042
Kitano Hospital, Tazuke Kofukai Medical Research Institute
Osaka, 530-8480
Hisatomi Clinic
Saga, Saga-ken, 849-0937
Saiki Central Hospital
Saiki, Oita Prefecture, 876-0851
Sanuki Municipal Hospital
Sanuki-shi, Kagawa-ken, 769-2393
Medical Corporation Souaikai Aihara Medical Clinic
Shinagawa-ku, Tokyo, 142-0053
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, Tokyo, 160-0008
Soka Sugiura Internal Medicine Clinic
Sōka, Saitama, 340-0034
Medical Corporation Heishinkai OCROM Clinic
Suita, Osaka, 565-0853
Takamatsu Red Cross Hospital
Takamatsu, Kagawa-ken, 760-0017
Japan Organization of Occupational Health and Safety Sanin Rosai Hospital
Yonago, Tottori, 683-8605
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Exploratory Study of MT-8554 in Subjects With Painful Diabetic Peripheral Neuropathy
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
- Being tested
- MT-8554, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-8554Drug
Also called Elismetrep
Oral Capsule
PlaceboDrug
Oral Capsule
| Study group | Role | What they receive |
|---|---|---|
| MT-8554 | Experimental | MT-8554 will be started from a low dose, and gradually increase the dose in order. Receives: Drug: MT-8554 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 12
Secondary outcomes (11)
Change from baseline in weekly mean 24-hour average NRS score at each assessment point
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.
Measured: Up to Week 12
Average weekly 24-hour NRS score during the 12 week treatment period 30% and 50% responder rates
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.
Measured: Baseline and Week 12
Change from baseline in weekly mean daily NRS score at each assessment point
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.
Measured: Up to Week 12
Change from baseline in weekly mean nocturnal average NRS score at each assessment point
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.
Measured: Up to Week 12
Change from baseline in weekly mean 24 hour worst NRS score at each assessment point
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.
Measured: Up to Week 12
Change from baseline in NPSI at each assessment point
Neuropathic Pain Symptom Inventory (NPSI) is the questionnaire to evaluate the different symptoms of neuropathic pain and each symptoms are evaluated from 0 (no pain) to 10 (worst possible pain). Higher NPSI scores indicated worse outcome.
Measured: Up to Week 12
Change from baseline in BPI pain severity at each assessment point
Brief Pain Inventory (BPI) is the questionnaire to assess the severity of pain from 0 (no pain) to 10 (pain as bad as patient can imagine). Higher BPI scores indicated worse outcome.
Measured: Up to Week 12
Change from baseline in BPI functional impairment at each assessment point
Brief Pain Inventory (BPI) is the questionnaire to assess the impact of pain on daily functions from 0 (does not interfere) to 10 (completely interferes). Higher BPI scores indicated worse outcome.
Measured: Up to Week 12
Change from baseline in MOS-SS at each assessment point
Medical Outcomes Study-Sleep Scale (MOS-SS) is the questionnaire to evaluate the "sleep disorder " "snoring" "sleep arousal with shortness of breath or headache" "sleep sufficiency" "somnolence" and "amount of sleep/optimal sleep" ranges from 0 (all of the time) to 6 (none of the time). Lower MOS-SS scores indicated worse outcome.
Measured: Up to Week 12
Proportion of PGIC responders at each assessment point
Patient Global Impression of Change (PGIC) is a questionnaire to evaluate the overall impression of pain improvement by patient from 1 (very much improved) to 7 (very much worse). Higher PGIC scores indicated worse outcome.
Measured: Up to Week 12
Proportion of CGIC responder at each assessment point
Clinician Global Impression of Change (CGIC) a questionnaire to evaluate the overall impression of pain improvement by clinician from 1 (very much improved) to 7 (very much worse). Higher CGIC scores indicated worse outcome.
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start16 Nov 2021
- Primary completion1 Nov 2022
- Study completion8 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- General Manager, Study director, Tanabe Pharma Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123196
- Sponsor's protocol ID
- MT-8554-A-201
- Other IDs
- jRCT2051210097
- Status last verified
- Dec 2025
- First submitted
- 18 Oct 2021
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When requested by a qualified researcher in the field of science or medicine, Tanabe Pharma Corporation will share clinical trial data that was collected from individual patients in a clinical trial with that researcher after a review committee of experts determines that such sharing is appropriate. Access Criteria: Please refer to the following link for conditions and limitations for sharing data. URL: https://www.tanabe-pharma.com/en/develop/protocol.html
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Exploratory Study of MT-8554 in Subjects With Painful Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT05123196
- Acronym / sponsor ID
- MT-8554-A-201
- Conditions
- Painful Diabetic Peripheral Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 8 Nov 2022 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MT-8554 | Experimental | Drug: MT-8554MT-8554 will be started from a low dose, and gradually increase the dose in order. |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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 neuropathy meet the following 3 criteria.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT-8554Also: ElismetrepOral Capsule | Drug | MT-8554 |
| PlaceboOral Capsule | Drug | Placebo |
Primary outcome
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.
11 secondary outcomes
Change from baseline in weekly mean 24-hour average NRS score at each assessment point
Time frame: Up to Week 12
Average weekly 24-hour NRS score during the 12 week treatment period 30% and 50% responder rates
Time frame: Baseline and Week 12
Change from baseline in weekly mean daily NRS score at each assessment point
Time frame: Up to Week 12
Change from baseline in weekly mean nocturnal average NRS score at each assessment point
Time frame: Up to Week 12
Change from baseline in weekly mean 24 hour worst NRS score at each assessment point
Time frame: Up to Week 12
Change from baseline in NPSI at each assessment point
Time frame: Up to Week 12
Change from baseline in BPI pain severity at each assessment point
Time frame: Up to Week 12
Change from baseline in BPI functional impairment at each assessment point
Time frame: Up to Week 12
Change from baseline in MOS-SS at each assessment point
Time frame: Up to Week 12
Proportion of PGIC responders at each assessment point
Time frame: Up to Week 12
Proportion of CGIC responder at each assessment point
Time frame: Up to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: Yes. When requested by a qualified researcher in the field of science or medicine, Tanabe Pharma Corporation will share clinical trial data that was collected from individual patients in a clinical trial with that researcher after a review committee of experts determines that such sharing is appropriate. Access Criteria: Please refer to the following link for conditions and limitations for sharing data. URL: https://www.tanabe-pharma.com/en/develop/protocol.html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
General Manager study director
Tanabe Pharma Corporation
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MT-8554 in people with Painful Diabetic Peripheral Neuropathy, run by Tanabe Pharma Corporation at 33 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the weekly mean 24-hour average NRS score at Week 12 in treatment period (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.