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Study of Mirogabalin for Central Neuropathic Pain

Primary Purpose

Central Neuropathic Pain

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Mirogabalin
Sponsored by
Daiichi Sankyo Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Neuropathic Pain focused on measuring Central neuropathic pain, Developmental phase III

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chubu-Rosai Hospital
  • Social Medical Corporation Daido Clinic
  • Honmachi Clinic
  • Nagoya City West Medical Center
  • Toyota Kosei Hospital
  • Nagoya Tokushukai General Hospital
  • Kainan Hospital
  • Hachinohe City Hospital
  • Hirosaki University Hospital
  • Chiba University Hospital
  • Chiba Rehabilitation Center
  • Funabashi Municipal Medical Center
  • Kimitsu Chuo Hospital
  • Ehime Prefectural Central Hospital
  • University of Fukui Hospital
  • Fukui-ken Saiseikai Hospital
  • Shin Komonji Hospital
  • Kyushu Rosai Hospital
  • Steel Memorial Yawata Hospital
  • Go Neurosurgical Clinic
  • Japan Organization of Occupational Health and Safety Spinal Injuries Center
  • Shin Yukuhashi Hospital
  • Fukushima Medical University Hospital
  • Southern TOHOKU Medical Clinic
  • Japanese Red Cross Maebashi Hospital
  • Goodlife Hospital
  • Medical Corporation Suiseikai Suiseikai Kajikawa Hospital
  • Hiroshima City Asa Citizens Hospital
  • Hiroshima Prefectural Hospital
  • Teine Keijinkai Hospital
  • Hakodate Municipal Hospital
  • Sapporo Medical University Hospital
  • Nakamura Memorial Hospital
  • Sapporo City General Hospital
  • Japanese Red Cross Asahikawa Hospital
  • Hokkaido Spinal Cord Injury Center
  • Kobe City Medical Center General Hospital
  • Japanese Red Cross Kobe Hospital
  • Hyogo Social Welfare Corporation Hyogo Rehabilitation Center Central Hospital
  • Japanese Red Cross Society Himeji Hospital
  • University of Tsukuba Hospital
  • Ibaraki Seinan Medical Center Hospital
  • Ishikawa Prefectural Central Hospital
  • Iwate Rehabilitation Center
  • Kagawa Prefectural Central Hospital
  • Shikoku Medical Center for Children and Adults
  • Japan Organization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital
  • Yokohama City Minato Red Cross Hospital
  • Yokohama City University Hospital
  • Kanagawa Rehabilitation Hospital
  • Sagamihara Kyodo Hospital
  • National Hospital Organaization Kumamoto Medical Center
  • Kumamoto Kinoh Hospital
  • Kumamoto Takumadai Rehabilitation Hospital
  • Kumamoto Rehabilitation Hospital
  • Uji-Tokushukai Medical Center
  • Mie University Hospital
  • Tohoku Rosai Hospital
  • National Hospital Organization Sendai Medical Center
  • Katta General Hospital
  • Junwakai Memorial Hospital
  • University of Miyazaki Hospital
  • Japan Red Cross Society Azumino Hospital
  • Nagasaki University Hospital
  • Nagasaki Rosai Hospital
  • Nara Prefecture General Rehabilitation Center
  • Japanese Red Cross Society Nagaoka Red Cross Hospital
  • Nagaoka Chuo General Hospital
  • Niigata City General Hospital
  • Niigata University Medical & Dental Hospital
  • Okayama City General Medical Center Okayama City Hospital
  • Kibikogen Rehabilitation Center For Employment Injuries
  • Medical Corporation Tapic Okinawa Rehabilitation Center Hospital
  • Osaka General Medical Center
  • Osaka University Hospital
  • Aijinkai Rehabilitation Hospital
  • Osaka Rosai Hospital
  • Saga-ken Medical Centre KOSEIKAN
  • Hanyu General Hospital
  • Otsu City Hospital
  • Saiseikai Shiga Hospital
  • Shimane University Hospital
  • Shizuoka City Shimizu Hospital
  • Fujieda Municipal General Hospital
  • Hamamatsu University Hospital
  • Japanese Red Cross Hamamatsu Hospital
  • Kikugawa General Hospital
  • Dokkyo Medical University Hospital
  • Jichi Medical University Hospital
  • Tokushima University Hospital
  • Makita General Hospital
  • Nihon University Itabashi Hospital
  • National Hospital Organaization Murayama Medical Center
  • Tottori University Hospital
  • Toyama University Hospital Hospital
  • Wakayama Medical University Hospital
  • Sanyudo Rehabilitation Center
  • Yamaguchi University Hospital
  • Yamaguchi Rosai Hospital
  • Yamanashi Prefectural Central Hospital
  • Medical Corporation Keiaikai Nakamura Hospital
  • Daegu Fatima Hospital
  • Chungnam National University Hospital
  • CHA Bundang Medical Center
  • Seoul National University Bundang Hospital
  • The Catholic University of Korea St. Vincent's Hospital
  • Ajou University Hospital
  • The Catholic University of Korea Incheon St. Mary's Hospital
  • Chonbuk National University Hospital
  • Pusan National University Hospital
  • Pusan National University Yangsan Hospital
  • Seoul Universtiy Hospital
  • The Catholic University of Korea Seoul St. Mary's Hospital
  • Samsung Medical Center
  • Hualien Tzu Chi Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mirogabalin

Placebo

Arm Description

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

Placebo (14-weeks)

Outcomes

Primary Outcome Measures

Average Daily Pain Score (ADPS)
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

Average Daily Pain Score (ADPS) Response Rate
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.
Pain Intensity Score Using the Short-Form McGill Pain Questionnaire (SF-MPQ)
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)
Patient Global Impression of Change
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.
Average Daily Sleep Interference score (ADSIS)
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.

Full Information

First Posted
April 1, 2019
Last Updated
February 1, 2021
Sponsor
Daiichi Sankyo Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03901352
Brief Title
Study of Mirogabalin for Central Neuropathic Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 12, 2019 (Actual)
Primary Completion Date
December 28, 2020 (Actual)
Study Completion Date
December 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Neuropathic Pain
Keywords
Central neuropathic pain, Developmental phase III

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirogabalin
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (14-weeks)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matching Placebo
Intervention Description
Matching placebo tablets for oral administration
Intervention Type
Drug
Intervention Name(s)
Mirogabalin
Other Intervention Name(s)
DS-5565
Intervention Description
Mirogabalin tablets for oral administration
Primary Outcome Measure Information:
Title
Average Daily Pain Score (ADPS)
Description
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.
Time Frame
Baseline to Week 14
Secondary Outcome Measure Information:
Title
Average Daily Pain Score (ADPS) Response Rate
Description
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.
Time Frame
at Week 14
Title
Pain Intensity Score Using the Short-Form McGill Pain Questionnaire (SF-MPQ)
Description
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)
Time Frame
Baseline to Week 14
Title
Patient Global Impression of Change
Description
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.
Time Frame
at Week 14
Title
Average Daily Sleep Interference score (ADSIS)
Description
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.
Time Frame
Baseline to Week 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Study Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Chubu-Rosai Hospital
City
Aichi
ZIP/Postal Code
455-8530
Country
Japan
Facility Name
Social Medical Corporation Daido Clinic
City
Aichi
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
Honmachi Clinic
City
Aichi
ZIP/Postal Code
460-0008
Country
Japan
Facility Name
Nagoya City West Medical Center
City
Aichi
ZIP/Postal Code
462-8508
Country
Japan
Facility Name
Toyota Kosei Hospital
City
Aichi
ZIP/Postal Code
470-0396
Country
Japan
Facility Name
Nagoya Tokushukai General Hospital
City
Aichi
ZIP/Postal Code
487-0016
Country
Japan
Facility Name
Kainan Hospital
City
Aichi
ZIP/Postal Code
498-8502
Country
Japan
Facility Name
Hachinohe City Hospital
City
Aomori
ZIP/Postal Code
031-8555
Country
Japan
Facility Name
Hirosaki University Hospital
City
Aomori
ZIP/Postal Code
036-8563
Country
Japan
Facility Name
Chiba University Hospital
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Chiba Rehabilitation Center
City
Chiba
ZIP/Postal Code
266-0005
Country
Japan
Facility Name
Funabashi Municipal Medical Center
City
Chiba
ZIP/Postal Code
273-8588
Country
Japan
Facility Name
Kimitsu Chuo Hospital
City
Chiba
ZIP/Postal Code
292-8535
Country
Japan
Facility Name
Ehime Prefectural Central Hospital
City
Ehime
ZIP/Postal Code
790-0024
Country
Japan
Facility Name
University of Fukui Hospital
City
Fukui
ZIP/Postal Code
910-1193
Country
Japan
Facility Name
Fukui-ken Saiseikai Hospital
City
Fukui
ZIP/Postal Code
918-8503
Country
Japan
Facility Name
Shin Komonji Hospital
City
Fukuoka
ZIP/Postal Code
800-0057
Country
Japan
Facility Name
Kyushu Rosai Hospital
City
Fukuoka
ZIP/Postal Code
800-0296
Country
Japan
Facility Name
Steel Memorial Yawata Hospital
City
Fukuoka
ZIP/Postal Code
805-8508
Country
Japan
Facility Name
Go Neurosurgical Clinic
City
Fukuoka
ZIP/Postal Code
811-1244
Country
Japan
Facility Name
Japan Organization of Occupational Health and Safety Spinal Injuries Center
City
Fukuoka
ZIP/Postal Code
820-8508
Country
Japan
Facility Name
Shin Yukuhashi Hospital
City
Fukuoka
ZIP/Postal Code
824-0026
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Southern TOHOKU Medical Clinic
City
Fukushima
ZIP/Postal Code
963-8052
Country
Japan
Facility Name
Japanese Red Cross Maebashi Hospital
City
Gunma
ZIP/Postal Code
371-0811
Country
Japan
Facility Name
Goodlife Hospital
City
Hiroshima
ZIP/Postal Code
720-0052
Country
Japan
Facility Name
Medical Corporation Suiseikai Suiseikai Kajikawa Hospital
City
Hiroshima
ZIP/Postal Code
730-0053
Country
Japan
Facility Name
Hiroshima City Asa Citizens Hospital
City
Hiroshima
ZIP/Postal Code
731-0293
Country
Japan
Facility Name
Hiroshima Prefectural Hospital
City
Hiroshima
ZIP/Postal Code
734-8530
Country
Japan
Facility Name
Teine Keijinkai Hospital
City
Hokkaido
ZIP/Postal Code
006-8555
Country
Japan
Facility Name
Hakodate Municipal Hospital
City
Hokkaido
ZIP/Postal Code
041-8680
Country
Japan
Facility Name
Sapporo Medical University Hospital
City
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Nakamura Memorial Hospital
City
Hokkaido
ZIP/Postal Code
060-8570
Country
Japan
Facility Name
Sapporo City General Hospital
City
Hokkaido
ZIP/Postal Code
060-8604
Country
Japan
Facility Name
Japanese Red Cross Asahikawa Hospital
City
Hokkaido
ZIP/Postal Code
070-8530
Country
Japan
Facility Name
Hokkaido Spinal Cord Injury Center
City
Hokkaido
ZIP/Postal Code
072-0015
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Hyōgo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Japanese Red Cross Kobe Hospital
City
Hyōgo
ZIP/Postal Code
651-0073
Country
Japan
Facility Name
Hyogo Social Welfare Corporation Hyogo Rehabilitation Center Central Hospital
City
Hyōgo
ZIP/Postal Code
651-2181
Country
Japan
Facility Name
Japanese Red Cross Society Himeji Hospital
City
Hyōgo
ZIP/Postal Code
670-8540
Country
Japan
Facility Name
University of Tsukuba Hospital
City
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Facility Name
Ibaraki Seinan Medical Center Hospital
City
Ibaraki
ZIP/Postal Code
306-0433
Country
Japan
Facility Name
Ishikawa Prefectural Central Hospital
City
Ishikawa
ZIP/Postal Code
920-8530
Country
Japan
Facility Name
Iwate Rehabilitation Center
City
Iwate
ZIP/Postal Code
020-0503
Country
Japan
Facility Name
Kagawa Prefectural Central Hospital
City
Kagawa
ZIP/Postal Code
760-8557
Country
Japan
Facility Name
Shikoku Medical Center for Children and Adults
City
Kagawa
ZIP/Postal Code
765-8597
Country
Japan
Facility Name
Japan Organization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital
City
Kanagawa
ZIP/Postal Code
222-0036
Country
Japan
Facility Name
Yokohama City Minato Red Cross Hospital
City
Kanagawa
ZIP/Postal Code
231-8682
Country
Japan
Facility Name
Yokohama City University Hospital
City
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Kanagawa Rehabilitation Hospital
City
Kanagawa
ZIP/Postal Code
243-0121
Country
Japan
Facility Name
Sagamihara Kyodo Hospital
City
Kanagawa
ZIP/Postal Code
252-5188
Country
Japan
Facility Name
National Hospital Organaization Kumamoto Medical Center
City
Kumamoto
ZIP/Postal Code
860-0008
Country
Japan
Facility Name
Kumamoto Kinoh Hospital
City
Kumamoto
ZIP/Postal Code
860-8518
Country
Japan
Facility Name
Kumamoto Takumadai Rehabilitation Hospital
City
Kumamoto
ZIP/Postal Code
862-0924
Country
Japan
Facility Name
Kumamoto Rehabilitation Hospital
City
Kumamoto
ZIP/Postal Code
869-1106
Country
Japan
Facility Name
Uji-Tokushukai Medical Center
City
Kyoto
ZIP/Postal Code
611-0041
Country
Japan
Facility Name
Mie University Hospital
City
Mie
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Tohoku Rosai Hospital
City
Miyagi
ZIP/Postal Code
981-8563
Country
Japan
Facility Name
National Hospital Organization Sendai Medical Center
City
Miyagi
ZIP/Postal Code
983-8520
Country
Japan
Facility Name
Katta General Hospital
City
Miyagi
ZIP/Postal Code
989-0231
Country
Japan
Facility Name
Junwakai Memorial Hospital
City
Miyazaki
ZIP/Postal Code
880-2112
Country
Japan
Facility Name
University of Miyazaki Hospital
City
Miyazaki
ZIP/Postal Code
889-1692
Country
Japan
Facility Name
Japan Red Cross Society Azumino Hospital
City
Nagano
ZIP/Postal Code
399-8292
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Nagasaki Rosai Hospital
City
Nagasaki
ZIP/Postal Code
857-0134
Country
Japan
Facility Name
Nara Prefecture General Rehabilitation Center
City
Nara
ZIP/Postal Code
636-0345
Country
Japan
Facility Name
Japanese Red Cross Society Nagaoka Red Cross Hospital
City
Niigata
ZIP/Postal Code
940-2485
Country
Japan
Facility Name
Nagaoka Chuo General Hospital
City
Niigata
ZIP/Postal Code
940-8653
Country
Japan
Facility Name
Niigata City General Hospital
City
Niigata
ZIP/Postal Code
950-1197
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Okayama City General Medical Center Okayama City Hospital
City
Okayama
ZIP/Postal Code
700-8557
Country
Japan
Facility Name
Kibikogen Rehabilitation Center For Employment Injuries
City
Okayama
ZIP/Postal Code
716-1241
Country
Japan
Facility Name
Medical Corporation Tapic Okinawa Rehabilitation Center Hospital
City
Okinawa
ZIP/Postal Code
904-2173
Country
Japan
Facility Name
Osaka General Medical Center
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Facility Name
Osaka University Hospital
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Aijinkai Rehabilitation Hospital
City
Osaka
ZIP/Postal Code
569-1116
Country
Japan
Facility Name
Osaka Rosai Hospital
City
Osaka
ZIP/Postal Code
591-8025
Country
Japan
Facility Name
Saga-ken Medical Centre KOSEIKAN
City
Saga
ZIP/Postal Code
840-8571
Country
Japan
Facility Name
Hanyu General Hospital
City
Saitama
ZIP/Postal Code
348-8505
Country
Japan
Facility Name
Otsu City Hospital
City
Shiga
ZIP/Postal Code
520-0804
Country
Japan
Facility Name
Saiseikai Shiga Hospital
City
Shiga
ZIP/Postal Code
520-3046
Country
Japan
Facility Name
Shimane University Hospital
City
Shimane
ZIP/Postal Code
693-8501
Country
Japan
Facility Name
Shizuoka City Shimizu Hospital
City
Shizuoka
ZIP/Postal Code
424-8636
Country
Japan
Facility Name
Fujieda Municipal General Hospital
City
Shizuoka
ZIP/Postal Code
426-8677
Country
Japan
Facility Name
Hamamatsu University Hospital
City
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Japanese Red Cross Hamamatsu Hospital
City
Shizuoka
ZIP/Postal Code
434-8533
Country
Japan
Facility Name
Kikugawa General Hospital
City
Shizuoka
ZIP/Postal Code
439-0022
Country
Japan
Facility Name
Dokkyo Medical University Hospital
City
Tochigi
ZIP/Postal Code
321-0293
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Makita General Hospital
City
Tokyo
ZIP/Postal Code
143-8505
Country
Japan
Facility Name
Nihon University Itabashi Hospital
City
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
National Hospital Organaization Murayama Medical Center
City
Tokyo
ZIP/Postal Code
208-0011
Country
Japan
Facility Name
Tottori University Hospital
City
Tottori
ZIP/Postal Code
683-8504
Country
Japan
Facility Name
Toyama University Hospital Hospital
City
Toyama
ZIP/Postal Code
930-0194
Country
Japan
Facility Name
Wakayama Medical University Hospital
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Sanyudo Rehabilitation Center
City
Yamagata
ZIP/Postal Code
992-0057
Country
Japan
Facility Name
Yamaguchi University Hospital
City
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
Facility Name
Yamaguchi Rosai Hospital
City
Yamaguchi
ZIP/Postal Code
756-0095
Country
Japan
Facility Name
Yamanashi Prefectural Central Hospital
City
Yamanashi
ZIP/Postal Code
400-8506
Country
Japan
Facility Name
Medical Corporation Keiaikai Nakamura Hospital
City
Ōita
ZIP/Postal Code
874-0937
Country
Japan
Facility Name
Daegu Fatima Hospital
City
Daegu
ZIP/Postal Code
41199
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center
City
Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
The Catholic University of Korea St. Vincent's Hospital
City
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Incheon St. Mary's Hospital
City
Gyeonggi-do
ZIP/Postal Code
21431
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Jeollabuk-do
ZIP/Postal Code
54907
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Pusan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Pusan
ZIP/Postal Code
50612
Country
Korea, Republic of
Facility Name
Seoul Universtiy Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
6351
Country
Korea, Republic of
Facility Name
Hualien Tzu Chi Hospital
City
Hualien
ZIP/Postal Code
97002
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei city
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei city
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD Sharing Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD Sharing URL
http://vivli.org/ourmember/daiichi-sankyo/

Learn more about this trial

Study of Mirogabalin for Central Neuropathic Pain

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