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A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain

Sponsor
Daiichi Sankyo Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT04094662
Collaborator
(none)
393
Enrollment
40
Locations
2
Arms
28.2
Actual Duration (Months)
9.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Investigate the efficacy and safety of mirogabalin in Chinese participants with diabetic peripheral neuropathic pain in comparison to placebo.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

The primary objective is to compare change from baseline in weekly Average Daily Pain Score (ADPS) at Week 14 in Chinese patients with Diabetic Peripheral Neuropathic Pain (DPNP) receiving mirogabalin versus placebo.

Study Design

Study Type:
Interventional
Actual Enrollment :
393 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain
Actual Study Start Date :
Sep 18, 2019
Actual Primary Completion Date :
Jan 17, 2022
Actual Study Completion Date :
Jan 24, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mirogabalin

Mirogabalin 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks maintenance dose.

Drug: Mirogabalin
Mirogabalin tablets for oral administration
Other Names:
  • DS-5565

    		•
    Placebo Comparator: Placebo

    Placebo (14-weeks)

    Drug: Placebo
    Matching placebo tablets for oral administration

    Outcome Measures

    Primary Outcome Measures

    1. Average Daily Pain Score (ADPS) [Baseline to Week 14]

      The pain scores on a scale of 0-10, where 0 = no pain and 10 = the worst possible pain. The weekly ADPS is based on participants daily pain scores.

    Secondary Outcome Measures

    1. ADPS responder rate [at Week 14]

      Ratio of Participants Responding to Treatment, as Measured by Average Daily Pain Score (ADPS) Reduction from Baseline. The ADPS is used to determine categorical response rates.

    2. Pain Intensity Score Using the Short-Form McGill Pain Questionnaire (SF-MPQ) [at Week 14]

      Participants rate their pain in three parts of the questionnaire, which are combined into a single pain intensity score: Part 1 - fifteen descriptors of pain intensity, on a scale of 0 (none) to 3 (severe) Part 2 - a visual analog scale (VAS), in which the participant rates pain on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain Part 3 - a Present Pain Intensity index in which the participant rates present pain intensity on a scale of 0 (no pain) to 5 (most intense pain)

    3. Patient Global Impression of Change [at Week 14]

      Participants rate their overall impression of how the present pain compares to baseline using a 7-point scale, where 1 = very much improved and 7 = very much worse. Patient Global Impression of Change scores are used to determine categorical responder rates.

    4. Average Daily Sleep Interference score (ADSIS) [at Week 14]

      The sleep interference scores on a scale of 0-10, where 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep. The weekly ADSIS is based on participants daily sleep interference scores.

    5. Medical Outcome Study (MOS) sleep scale [at Week 14]

      Participants rate their sleep quality during the past 4 weeks in three parts of the questionnaire: Part 1 - The participants rate the average time required to fall asleep, 0-15 minutes = 1, 16-30 minutes = 2, 31-45 minutes = 3, 46-60 minutes = 4, More than 60 minutes = 5. Part 2 - The participants give the number of hours per night for the average hours of sleep per night. Part 3 - The participants using a score of 1 (all of the time) to 5 (none of the time) to rate their sleep disturbance in the following areas: difficulty in falling asleep or remaining asleep, difficulty in staying awake during the day, difficulty in breathing, and snoring during sleep.

    6. Five Level EuroQol-5D (EQ-5D) version [at Week 14]

      Participants rate their Quality of Life in the following dimensions: mobility (5-point scale), self-care (5-point scale), usual activities (5-point scale), pain/discomfort (5-point scale), and anxiety/depression(5-point scale) that are combined into an overall health utilities index. Participants also rate their perception of overall health using VAS, with zero indicating worst health and 100 representing best imaginable health.

    Other Outcome Measures

    1. Actigraphy signal collected from a wrist-worn medical-grade sensor [at Week 14]

      Result of physical activity during waking hours and participants' sleep will be evaluated to explore a relationship between participants reported outcomes and actigraphy signal collected from a wrist-worn medical-grade sensor (ActiGraph GT9X Link). Only participants who signed a separate informed consent form for wearing medical-grade sensor will be included in this evaluation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Type 1 or type 2 diabetes mellitus at screening

    • Painful distal symmetric polyneuropathy, diagnosed at least 6 months prior to screening (see Procedures manual for the Diagnosis of Diabetic Peripheral Neuropathy and Neurological Examination for details)

    Exclusion Criteria:

    • HbA1c (National Glycohemoglobin Standardization Program) > 10.0% at screening

    • Uncontrolled blood glucose within 1 month prior to screening, at screening or randomization

    • Other severe pain at screening or randomization, unrelated to DPN, that may confound the assessment of DPNP

    • Neurologic disorders at screening or randomization, unrelated to DPN, that may confound the assessment of DPNP

    • Major psychiatric disorders at screening or randomization

    • Creatinine clearance (using the Cockcroft-Gault equation) < 60 mL/min at screening

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Chaoyang Hospital, Capital Medical University Beijing China 100020
    2 Peking University First Hospital Beijing China 100034
    3 Beijing Friendship Hospital, Capital Medical University Beijing China 100050
    4 Xuanwu Hospital Capital Medical University Beijing China 100053
    5 Special Medical Center of Chinese PLA Rocket Force Beijing China 100088
    6 Beijing PingGu Hospital Beijing China 101200
    7 Cangzhou Central Hospital Cangzhou China 061001
    8 Jilin Province People's Hospital Chang chun China 130021
    9 The First Hospital of Changsha Changsha China 410005
    10 The Second Xiangya Hospital of Central South University Changsha China 410011
    11 Peace Hospital Affiliated to Changzhi Medical College Changzhi China 046000
    12 West China Hospital, Sichuan University Chengdu China 610041
    13 The Fourth People's Hospital of Chongqing Chongqing China 400010
    14 Affiliated Zhongshan Hospital of Dalian University Dalian China 116001
    15 Foshan First People's Hospital Foshan China 528000
    16 Nanfang Hospital of Southern Medical Hospital Guangzhou China 510515
    17 Guizhou Provincial People's Hospital Guizhou China 550002
    18 The First Affiliated Hospital of Anhui Medical University Hefei China 230022
    19 Jiaxing Second Hospital Jiaxing China 314000
    20 Jilin Central General Hospital Jilin China 132011
    21 The First Affiliated Hospital of Jinzhou Medical University Jingzhou China 121001
    22 Yunnan First People's Hospital Kunming China 650032
    23 The First Affiliated Hospital of Henan University of Science and Technology Luoyang China 471000
    24 Luoyang Central Hospital Affiliated to Zhengzhou University Luoyang China 471009
    25 Jiangxi Pingxiang People's Hospital Pingxiang China 337055
    26 The Affiliated Hospital of Qingdao University Qingdao China 266071
    27 Shanghai Huashan Hospital Shanghai China 200040
    28 Shanghai Tenth People's Hospital Shanghai China 200072
    29 Yangpu Hospital,Tongji University Shanghai China 200090
    30 Shanghai Pudong Hospital Shanghai China 200135
    31 Central Hospital of Minhang District Shanghai Shanghai China 201199
    32 Siping Central Hospital Siping China 136000
    33 The First Hospital of Shanxi Medical University Taiyuan China 030001
    34 The Second Hospital of Tianjin Medical University Tianjin China 300211
    35 The 2nd Affiliated Hospital of The 2nd School of Medicine, Wenzhou Medical University Wenzhou China 325027
    36 Renmin Hospital of Wuhan University (Hubei General Hospital) Wuhan China 430060
    37 Wuxi People's Hospital Wuxi China 214023
    38 The First Affiliated Hospital of Xi'an Jiaotong University Xi'an China 710061
    39 The First Affiliated Hospital of Xiamen University Xiamen China 361003
    40 Zigong Fourth People's Hospital Zigong China 643000

    Sponsors and Collaborators

    • Daiichi Sankyo Co., Ltd.

    Investigators

    • Study Director: Clinical Study Leader, Daiichi Sankyo, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daiichi Sankyo Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT04094662
    Other Study ID Numbers:
    • DS5565-A-A315
    First Posted:
    Sep 19, 2019
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Feb 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:
    Neuralgia
    Diabetic Neuropathies

    Study Results

    No Results Posted as of Mar 2, 2022