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

Sponsor
Mitsubishi Tanabe Pharma Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05123196
Collaborator
(none)
144
Enrollment
33
Locations
2
Arms
18.5
Anticipated Duration (Months)
4.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Exploratory Study of MT-8554 in Subjects With Painful Diabetic Peripheral Neuropathy
Actual Study Start Date :
Nov 16, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: MT-8554

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

Drug: MT-8554
Oral Capsule
Other Names:
  • Elismetrep

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    Oral Capsule

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in the weekly mean 24-hour average NRS score at Week 12 in treatment period [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 Outcome Measures

    1. Change from baseline in weekly mean 24-hour average NRS score at each assessment point [Up to 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.

    2. Average weekly 24-hour NRS score during the 12 week treatment period 30% and 50% responder rates [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.

    3. Change from baseline in weekly mean daily NRS score at each assessment point [Up to 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.

    4. Change from baseline in weekly mean nocturnal average NRS score at each assessment point [Up to 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.

    5. Change from baseline in weekly mean 24 hour worst NRS score at each assessment point [Up to 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.

    6. Change from baseline in NPSI at each assessment point [Up to Week 12]

      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.

    7. Change from baseline in BPI pain severity at each assessment point [Up to Week 12]

      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.

    8. Change from baseline in BPI functional impairment at each assessment point [Up to Week 12]

      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.

    9. Change from baseline in MOS-SS at each assessment point [Up to Week 12]

      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.

    10. Proportion of PGIC responders at each assessment point [Up to Week 12]

      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.

    11. Proportion of CGIC responder at each assessment point [Up to Week 12]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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
      1. Decreased or eliminated bilateral Achilles tendon reflexes
      1. 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

    1. 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.

    2. 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%.

    3. 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.

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

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

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

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

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

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

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

    8. 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.

    9. Patients with HbA1c > 10.5%.

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

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

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

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

    14. 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.

    15. 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.

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

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

    18. Prior exposure to MT-8554.

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yachiyo Hospital Anjo-City Aichi Japan 446-8510
    2 Japan Organization of Occupational Health and Safety Chubu Rosai Hospital Nagoya-City Aichi Japan 455-8530
    3 JUNEIKAI Medical Corporation Akaicho Clinic Chiba-shi Chiba Japan 260-0804
    4 Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital Fukuoka-shi Fukuoka Japan 811-0213
    5 TOJITAMA thyroid and diabetes Clinic Fukuoka-shi Fukuoka Japan 815-0033
    6 Kunisaki Makoto Clinic Fukuoka-Shi Fukuoka Japan 819-0168
    7 Steel Memorial Yawata Hospital Kitakyushu-shi Fukuoka Japan 805-0050
    8 Medical Corporation Kouhoukai Takagi Hospital Okawa-shi Fukuoka Japan 831-0016
    9 Matsunami Health Promotion Clinic Hashima-gun Gifu Japan 501-6061
    10 Kikuchi Clinic of Internal Medicine Maebashi-city Gunma Japan 370-3573
    11 Japanese Red Cross Asahikawa Hospital Asahikawa-City Hokkaido Japan 070-8530
    12 Hakodate Central General Hospital Hakodate-City Hokkaido Japan 040-8585
    13 Jiyugaoka Yamada Internal Medicine Clinic Obihiro-City Hokkaido Japan 080-0848
    14 Sanuki Municipal Hospital Sanuki-shi Kagawa Japan 769-2393
    15 Takamatsu Red Cross Hospital Takamatsu-shi Kagawa Japan 760-0017
    16 Shonan Fujisawa Tokushukai Hospital Fujisawa-shi Kanagawa Japan 251-0041
    17 Shunkaikai Inoue Hospital Nagasaki-shi Nagasaki Japan 850-0045
    18 Medical Corporation Keiaikai Nakamura Hospital Beppu-City Oita Japan 874-0937
    19 Medical Corporation Ikeikai Inobe Funai Clinic Oita-City Oita Japan 870-0021
    20 Abe Diabetes Clinic Oita-City Oita Japan 870-0039
    21 Saiki Central Hospital Saiki-City Oita Japan 876-0851
    22 Medical Corporation Heishinkai OCROM Clinic Suita-City Osaka Japan 565-0853
    23 Hisatomi Clinic Saga-City Saga Japan 849-0937
    24 Soka Sugiura Internal Medicine Clinic Soka-City Saitama Japan 340-0034
    25 OMI MEDICAL CENTER, Social Medical Corporation Seikoukai Kusatsu-City Shiga Japan 525-8585
    26 Kumanomae Nishimura Naika Clinic Arakawa-ku Tokyo Japan 116-0012
    27 Tokyo Center Clinic Chuo-ku Tokyo Japan 103-0028
    28 Sugawara Clinic Nerima-ku Tokyo Japan 177-0041
    29 Ome Municipal General Hospital Ome-shi Tokyo Japan 198-0042
    30 Medical Corporation Souaikai Aihara Medical Clinic Shinagawa-ku Tokyo Japan 142-0053
    31 Medical Corporation Heishinkai ToCROM Clinic Shinjuku-ku Tokyo Japan 160-0008
    32 Japan Organization of Occupational Health and Safety Sanin Rosai Hospital Yonago Tottori Japan 683-8605
    33 Kitano Hospital, Tazuke Kofukai Medical Research Institute Osaka Japan 530-8480

    Sponsors and Collaborators

    • Mitsubishi Tanabe Pharma Corporation

    Investigators

    • Study Director: General Manager, Mitsubishi Tanabe Pharma Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mitsubishi Tanabe Pharma Corporation
    ClinicalTrials.gov Identifier:
    NCT05123196
    Other Study ID Numbers:
    • MT-8554-A-201
    • jRCT2051210097
    First Posted:
    Nov 17, 2021
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Peripheral Nervous System Diseases
    Diabetic Neuropathies
    Pain

    Study Results

    No Results Posted as of Jun 21, 2022