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Study of Mirogabalin for Central Neuropathic Pain

Sponsor
Daiichi Sankyo Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03901352
Collaborator
(none)
300
Enrollment
118
Locations
2
Arms
21.6
Actual Duration (Months)
2.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Investigate the efficacy and safety of mirogabalin in participants with central neuropathic pain in comparison to placebo

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

[Double Blind Phase] The primary objective is to compare change in the Average Daily Pain Score (ADPS) from baseline to Week 14 in Asian participants with central neuropathic pain (central neuropathic pain after spinal cord injury) receiving mirogabalin versus placebo.

[Open Extension Phase] The objective is to assess the long-term safety and efficacy of mirogabalin in participants with central neuropathic pain (central neuropathic pain after spinal cord injury, central post stroke pain, and central neuropathic pain in Parkinson's disease).

Study Design

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
During the Double-blind Phase, participants will be randomized into parallel treatment arms. During the Open Extension Phase, all participants will be assigned to a single group.During the Double-blind Phase, participants will be randomized into parallel treatment arms. During the Open Extension Phase, all participants will be assigned to a single group.
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
During the Double-blind Phase, masking will be triple (as shown above). During the Open Extension Phase, there will be no masking - the allocation is not applicable.
Primary Purpose:
Treatment
Official Title:
An Asian, Multicenter, Randomized, Double-blind, Placebo-controlled, 14-week Study of Mirogabalin in Participants With Central Neuropathic Pain Followed by a 52-week, Open-label Extension
Actual Study Start Date :
Mar 12, 2019
Actual Primary Completion Date :
Dec 28, 2020
Actual Study Completion Date :
Dec 28, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mirogabalin

The patients with creatinine clearance (CLcr) ≥ 60 mL/min: Mirogabalin 20 mg or 30 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks maintenance dose. The patients with creatinine clearance (CLcr) 30 to < 60 mL/min: Mirogabalin 10 mg or 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
    Other Names:
  • Matching Placebo

    		•

    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. Average Daily Pain Score (ADPS) Response 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) [Baseline to 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 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) [Baseline to 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.

    Eligibility Criteria

    Criteria

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

    • Spinal cord injury (SCI) due to trauma

    • American Spinal Injury Association impairment scale A, B, C, or D

    Exclusion Criteria:

    • Other severe pain at screening or randomization, unrelated to central neuropathic pain after SCI, that may confound the assessment of central neuropathic pain after SCI

    • Neurologic disorders at screening or randomization, unrelated to central neuropathic pain after SCI, that may confound the assessment of central neuropathic pain after SCI

    • Major psychiatric disorders within 1 year prior to screening

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chubu-Rosai Hospital Aichi Japan 455-8530
    2 Social Medical Corporation Daido Clinic Aichi Japan 457-8511
    3 Honmachi Clinic Aichi Japan 460-0008
    4 Nagoya City West Medical Center Aichi Japan 462-8508
    5 Toyota Kosei Hospital Aichi Japan 470-0396
    6 Nagoya Tokushukai General Hospital Aichi Japan 487-0016
    7 Kainan Hospital Aichi Japan 498-8502
    8 Hachinohe City Hospital Aomori Japan 031-8555
    9 Hirosaki University Hospital Aomori Japan 036-8563
    10 Chiba University Hospital Chiba Japan 260-8677
    11 Chiba Rehabilitation Center Chiba Japan 266-0005
    12 Funabashi Municipal Medical Center Chiba Japan 273-8588
    13 Kimitsu Chuo Hospital Chiba Japan 292-8535
    14 Ehime Prefectural Central Hospital Ehime Japan 790-0024
    15 University of Fukui Hospital Fukui Japan 910-1193
    16 Fukui-ken Saiseikai Hospital Fukui Japan 918-8503
    17 Shin Komonji Hospital Fukuoka Japan 800-0057
    18 Kyushu Rosai Hospital Fukuoka Japan 800-0296
    19 Steel Memorial Yawata Hospital Fukuoka Japan 805-8508
    20 Go Neurosurgical Clinic Fukuoka Japan 811-1244
    21 Japan Organization of Occupational Health and Safety Spinal Injuries Center Fukuoka Japan 820-8508
    22 Shin Yukuhashi Hospital Fukuoka Japan 824-0026
    23 Fukushima Medical University Hospital Fukushima Japan 960-1295
    24 Southern TOHOKU Medical Clinic Fukushima Japan 963-8052
    25 Japanese Red Cross Maebashi Hospital Gunma Japan 371-0811
    26 Goodlife Hospital Hiroshima Japan 720-0052
    27 Medical Corporation Suiseikai Suiseikai Kajikawa Hospital Hiroshima Japan 730-0053
    28 Hiroshima City Asa Citizens Hospital Hiroshima Japan 731-0293
    29 Hiroshima Prefectural Hospital Hiroshima Japan 734-8530
    30 Teine Keijinkai Hospital Hokkaido Japan 006-8555
    31 Hakodate Municipal Hospital Hokkaido Japan 041-8680
    32 Sapporo Medical University Hospital Hokkaido Japan 060-8543
    33 Nakamura Memorial Hospital Hokkaido Japan 060-8570
    34 Sapporo City General Hospital Hokkaido Japan 060-8604
    35 Japanese Red Cross Asahikawa Hospital Hokkaido Japan 070-8530
    36 Hokkaido Spinal Cord Injury Center Hokkaido Japan 072-0015
    37 Kobe City Medical Center General Hospital Hyōgo Japan 650-0047
    38 Japanese Red Cross Kobe Hospital Hyōgo Japan 651-0073
    39 Hyogo Social Welfare Corporation Hyogo Rehabilitation Center Central Hospital Hyōgo Japan 651-2181
    40 Japanese Red Cross Society Himeji Hospital Hyōgo Japan 670-8540
    41 University of Tsukuba Hospital Ibaraki Japan 305-8576
    42 Ibaraki Seinan Medical Center Hospital Ibaraki Japan 306-0433
    43 Ishikawa Prefectural Central Hospital Ishikawa Japan 920-8530
    44 Iwate Rehabilitation Center Iwate Japan 020-0503
    45 Kagawa Prefectural Central Hospital Kagawa Japan 760-8557
    46 Shikoku Medical Center for Children and Adults Kagawa Japan 765-8597
    47 Japan Organization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital Kanagawa Japan 222-0036
    48 Yokohama City Minato Red Cross Hospital Kanagawa Japan 231-8682
    49 Yokohama City University Hospital Kanagawa Japan 236-0004
    50 Kanagawa Rehabilitation Hospital Kanagawa Japan 243-0121
    51 Sagamihara Kyodo Hospital Kanagawa Japan 252-5188
    52 National Hospital Organaization Kumamoto Medical Center Kumamoto Japan 860-0008
    53 Kumamoto Kinoh Hospital Kumamoto Japan 860-8518
    54 Kumamoto Takumadai Rehabilitation Hospital Kumamoto Japan 862-0924
    55 Kumamoto Rehabilitation Hospital Kumamoto Japan 869-1106
    56 Uji-Tokushukai Medical Center Kyoto Japan 611-0041
    57 Mie University Hospital Mie Japan 514-8507
    58 Tohoku Rosai Hospital Miyagi Japan 981-8563
    59 National Hospital Organization Sendai Medical Center Miyagi Japan 983-8520
    60 Katta General Hospital Miyagi Japan 989-0231
    61 Junwakai Memorial Hospital Miyazaki Japan 880-2112
    62 University of Miyazaki Hospital Miyazaki Japan 889-1692
    63 Japan Red Cross Society Azumino Hospital Nagano Japan 399-8292
    64 Nagasaki University Hospital Nagasaki Japan 852-8501
    65 Nagasaki Rosai Hospital Nagasaki Japan 857-0134
    66 Nara Prefecture General Rehabilitation Center Nara Japan 636-0345
    67 Japanese Red Cross Society Nagaoka Red Cross Hospital Niigata Japan 940-2485
    68 Nagaoka Chuo General Hospital Niigata Japan 940-8653
    69 Niigata City General Hospital Niigata Japan 950-1197
    70 Niigata University Medical & Dental Hospital Niigata Japan 951-8520
    71 Okayama City General Medical Center Okayama City Hospital Okayama Japan 700-8557
    72 Kibikogen Rehabilitation Center For Employment Injuries Okayama Japan 716-1241
    73 Medical Corporation Tapic Okinawa Rehabilitation Center Hospital Okinawa Japan 904-2173
    74 Osaka General Medical Center Osaka Japan 558-8558
    75 Osaka University Hospital Osaka Japan 565-0871
    76 Aijinkai Rehabilitation Hospital Osaka Japan 569-1116
    77 Osaka Rosai Hospital Osaka Japan 591-8025
    78 Saga-ken Medical Centre KOSEIKAN Saga Japan 840-8571
    79 Hanyu General Hospital Saitama Japan 348-8505
    80 Otsu City Hospital Shiga Japan 520-0804
    81 Saiseikai Shiga Hospital Shiga Japan 520-3046
    82 Shimane University Hospital Shimane Japan 693-8501
    83 Shizuoka City Shimizu Hospital Shizuoka Japan 424-8636
    84 Fujieda Municipal General Hospital Shizuoka Japan 426-8677
    85 Hamamatsu University Hospital Shizuoka Japan 431-3192
    86 Japanese Red Cross Hamamatsu Hospital Shizuoka Japan 434-8533
    87 Kikugawa General Hospital Shizuoka Japan 439-0022
    88 Dokkyo Medical University Hospital Tochigi Japan 321-0293
    89 Jichi Medical University Hospital Tochigi Japan 329-0498
    90 Tokushima University Hospital Tokushima Japan 770-8503
    91 Makita General Hospital Tokyo Japan 143-8505
    92 Nihon University Itabashi Hospital Tokyo Japan 173-8610
    93 National Hospital Organaization Murayama Medical Center Tokyo Japan 208-0011
    94 Tottori University Hospital Tottori Japan 683-8504
    95 Toyama University Hospital Hospital Toyama Japan 930-0194
    96 Wakayama Medical University Hospital Wakayama Japan 641-8510
    97 Sanyudo Rehabilitation Center Yamagata Japan 992-0057
    98 Yamaguchi University Hospital Yamaguchi Japan 755-8505
    99 Yamaguchi Rosai Hospital Yamaguchi Japan 756-0095
    100 Yamanashi Prefectural Central Hospital Yamanashi Japan 400-8506
    101 Medical Corporation Keiaikai Nakamura Hospital Ōita Japan 874-0937
    102 Daegu Fatima Hospital Daegu Korea, Republic of 41199
    103 Chungnam National University Hospital Daejeon Korea, Republic of 35015
    104 CHA Bundang Medical Center Gyeonggi-do Korea, Republic of 13496
    105 Seoul National University Bundang Hospital Gyeonggi-do Korea, Republic of 13620
    106 The Catholic University of Korea St. Vincent's Hospital Gyeonggi-do Korea, Republic of 16247
    107 Ajou University Hospital Gyeonggi-do Korea, Republic of 16499
    108 The Catholic University of Korea Incheon St. Mary's Hospital Gyeonggi-do Korea, Republic of 21431
    109 Chonbuk National University Hospital Jeollabuk-do Korea, Republic of 54907
    110 Pusan National University Hospital Pusan Korea, Republic of 49241
    111 Pusan National University Yangsan Hospital Pusan Korea, Republic of 50612
    112 Seoul Universtiy Hospital Seoul Korea, Republic of 03080
    113 The Catholic University of Korea Seoul St. Mary's Hospital Seoul Korea, Republic of 06591
    114 Samsung Medical Center Seoul Korea, Republic of 6351
    115 Hualien Tzu Chi Hospital Hualien Taiwan 97002
    116 National Taiwan University Hospital Taipei city Taiwan 10002
    117 Taipei Veterans General Hospital Taipei city Taiwan 11217
    118 Chang Gung Memorial Hospital Taoyuan Taiwan 33305

    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:
    NCT03901352
    Other Study ID Numbers:
    • DS5565-A-J314
    • 194653
    First Posted:
    Apr 3, 2019
    Last Update Posted:
    Feb 2, 2021
    Last Verified:
    Feb 1, 2021
    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
    Keywords provided by Daiichi Sankyo Co., Ltd.
    Central neuropathic pain
    Developmental phase III
    Additional relevant MeSH terms:
    Neuralgia

    Study Results

    No Results Posted as of Feb 2, 2021