- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03901352
Study of Mirogabalin for Central Neuropathic Pain
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Aichi, Japan, 455-8530
- Chubu-Rosai Hospital
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Aichi, Japan, 457-8511
- Social Medical Corporation Daido Clinic
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Aichi, Japan, 460-0008
- Honmachi Clinic
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Aichi, Japan, 462-8508
- Nagoya City West Medical Center
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Aichi, Japan, 470-0396
- Toyota Kosei Hospital
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Aichi, Japan, 487-0016
- Nagoya Tokushukai General Hospital
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Aichi, Japan, 498-8502
- Kainan Hospital
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Aomori, Japan, 031-8555
- Hachinohe City Hospital
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Aomori, Japan, 036-8563
- Hirosaki University Hospital
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Chiba, Japan, 260-8677
- Chiba University Hospital
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Chiba, Japan, 266-0005
- Chiba Rehabilitation Center
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Chiba, Japan, 273-8588
- Funabashi Municipal Medical Center
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Chiba, Japan, 292-8535
- Kimitsu Chuo Hospital
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Ehime, Japan, 790-0024
- Ehime Prefectural Central Hospital
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Fukui, Japan, 918-8503
- Fukui-ken Saiseikai Hospital
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Fukui, Japan, 910-1193
- University of Fukui Hospital
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Fukuoka, Japan, 800-0057
- Shin Komonji Hospital
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Fukuoka, Japan, 800-0296
- Kyushu Rosai Hospital
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Fukuoka, Japan, 805-8508
- Steel Memorial Yawata Hospital
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Fukuoka, Japan, 811-1244
- Go Neurosurgical Clinic
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Fukuoka, Japan, 820-8508
- Japan Organization of Occupational Health and Safety SPINAL INJURIES CENTER
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Fukuoka, Japan, 824-0026
- Shin Yukuhashi Hospital
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Fukushima, Japan, 960-1295
- Fukushima Medical University Hospital
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Fukushima, Japan, 963-8052
- Southern Tohoku Medical Clinic
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Gunma, Japan, 371-0811
- Japanese Red Cross Maebashi Hospital
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Hiroshima, Japan, 720-0052
- Goodlife Hospital
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Hiroshima, Japan, 730-0053
- Medical corporation Suiseikai Suiseikai Kajikawa Hospital
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Hiroshima, Japan, 731-0293
- Hiroshima City Asa Citizens Hospital
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Hiroshima, Japan, 734-8530
- Hiroshima Prefectural Hospital
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Hokkaido, Japan, 006-8555
- Teine Keijinkai Hospital
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Hokkaido, Japan, 041-8680
- Hakodate Municipal Hospital
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Hokkaido, Japan, 060-8543
- Sapporo Medical University Hospital
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Hokkaido, Japan, 060-8570
- Nakamura Memorial Hospital
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Hokkaido, Japan, 060-8604
- Sapporo City General Hospital
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Hokkaido, Japan, 070-8530
- Japanese Red Cross Asahikawa Hospital
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Hokkaido, Japan, 072-0015
- Hokkaido Spinal Cord Injury Center
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Hyōgo, Japan, 650-0047
- Kobe City Medical Center General Hospital
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Hyōgo, Japan, 651-0073
- Japanese Red Cross Kobe Hospital
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Hyōgo, Japan, 651-2181
- Hyogo Social Welfare Corporation Hyogo Rehabilitation Center Central Hospital
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Hyōgo, Japan, 670-8540
- Japanese Red Cross Society Himeji Hospital
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Ibaraki, Japan, 305-8576
- University of Tsukuba Hospital
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Ibaraki, Japan, 306-0433
- Ibaraki Seinan Medical Center Hospital
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Ishikawa, Japan, 920-8530
- Ishikawa Prefectural Central Hospital
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Iwate, Japan, 020-0503
- Iwate Rehabilitation Center
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Kagawa, Japan, 760-8557
- Kagawa Prefectural Central Hospital
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Kagawa, Japan, 765-8597
- Shikoku Medical Center for Children and Adults
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Kanagawa, Japan, 222-0036
- Japan Organization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital
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Kanagawa, Japan, 231-8682
- Yokohama City Minato Red Cross Hospital
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Kanagawa, Japan, 236-0004
- Yokohama City University Hospital
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Kanagawa, Japan, 243-0121
- Kanagawa Rehabilitation Hospital
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Kanagawa, Japan, 252-5188
- Sagamihara Kyodo Hospital
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Kumamoto, Japan, 860-8518
- Kumamoto Kinoh Hospital
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Kumamoto, Japan, 860-0008
- National Hospital Organaization Kumamoto Medical Center
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Kumamoto, Japan, 862-0924
- Kumamoto Takumadai Rehabilitation Hospital
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Kumamoto, Japan, 869-1106
- Kumamoto Rehabilitation Hospital
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Kyoto, Japan, 611-0041
- Uji-Tokushukai Medical Center
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Mie, Japan, 514-8507
- Mie University Hospital
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Miyagi, Japan, 981-8563
- Tohoku Rosai Hospital
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Miyagi, Japan, 983-8520
- National Hospital Organization Sendai Medical Center
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Miyagi, Japan, 989-0231
- Katta General Hospital
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Miyazaki, Japan, 880-2112
- Junwakai Memorial Hospital
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Miyazaki, Japan, 889-1692
- University of Miyazaki Hospital
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Nagano, Japan, 399-8292
- Japan Red Cross Society Azumino Hospital
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Nagasaki, Japan, 852-8501
- Nagasaki University Hospital
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Nagasaki, Japan, 857-0134
- Nagasaki Rosai Hospital
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Nara, Japan, 636-0345
- Nara Prefecture General Rehabilitation Center
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Niigata, Japan, 951-8520
- Niigata University Medical & Dental Hospital
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Niigata, Japan, 940-2485
- Japanese Red Cross Society Nagaoka Red Cross Hospital
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Niigata, Japan, 940-8653
- Nagaoka Chuo General Hospital
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Niigata, Japan, 950-1197
- Niigata City General Hospital
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Okayama, Japan, 700-8557
- Okayama City General Medical Center Okayama City Hospital
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Okayama, Japan, 716-1241
- Kibikogen Rehabilitation Center For Employment Injuries
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Okinawa, Japan, 904-2173
- Medical Corporation Tapic Okinawa Rehabilitation Center Hospital
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Osaka, Japan, 565-0871
- Osaka University Hospital
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Osaka, Japan, 558-8558
- Osaka General Medical Center
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Osaka, Japan, 569-1116
- Aijinkai Rehabilitation Hospital
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Osaka, Japan, 591-8025
- Osaka Rosai Hospital
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Saga, Japan, 840-8571
- Saga-Ken Medical Centre Koseikan
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Saitama, Japan, 348-8505
- Hanyu General Hospital
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Shiga, Japan, 520-0804
- Otsu City Hospital
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Shiga, Japan, 520-3046
- Saiseikai Shiga Hospital
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Shimane, Japan, 693-8501
- Shimane University Hospital
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Shizuoka, Japan, 424-8636
- Shizuoka City Shimizu Hospital
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Shizuoka, Japan, 426-8677
- Fujieda Municipal General Hospital
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Shizuoka, Japan, 431-3192
- Hamamatsu University Hospital
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Shizuoka, Japan, 434-8533
- Japanese Red Cross Hamamatsu Hospital
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Shizuoka, Japan, 439-0022
- Kikugawa General Hospital
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Tochigi, Japan, 329-0498
- Jichi Medical University Hospital
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Tochigi, Japan, 321-0293
- Dokkyo Medical University Hospital
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Tokushima, Japan, 770-8503
- Tokushima University Hospital
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Tokyo, Japan, 143-8505
- Makita General Hospital
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Tokyo, Japan, 173-8610
- Nihon University Itabashi Hospital
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Tokyo, Japan, 208-0011
- National Hospital Organaization Murayama Medical Center
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Tottori, Japan, 683-8504
- Tottori University Hospital
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Toyama, Japan, 930-0194
- Toyama University Hospital Hospital
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Wakayama, Japan, 641-8510
- Wakayama Medical University Hospital
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Yamagata, Japan, 992-0057
- Sanyudo Rehabilitation Center
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Yamaguchi, Japan, 755-8505
- Yamaguchi University Hospital
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Yamaguchi, Japan, 756-0095
- Yamaguchi Rosai Hospital
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Yamanashi, Japan, 400-8506
- Yamanashi Prefectural Central Hospital
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Ōita, Japan, 874-0937
- Medical Corporation Keiaikai Nakamura Hospital
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Daegu, Korea, Republic of, 41199
- Daegu fatima hospital
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Daejeon, Korea, Republic of, 35015
- Chungnam National University Hospital
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Gyeonggi-do, Korea, Republic of, 13620
- Seoul National University Bundang Hospital
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Gyeonggi-do, Korea, Republic of, 13496
- CHA Bundang Medical Center
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Gyeonggi-do, Korea, Republic of, 16247
- The Catholic University of Korea St. Vincent'S Hospital
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Gyeonggi-do, Korea, Republic of, 16499
- Ajou University Hospital
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Gyeonggi-do, Korea, Republic of, 21431
- The Catholic University of Korea Incheon St. Mary's Hospital
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Jeollabuk-do, Korea, Republic of, 54907
- Chonbuk National University Hospital
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Pusan, Korea, Republic of, 49241
- Pusan National University Hospital
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Pusan, Korea, Republic of, 50612
- Pusan National University Yangsan Hospital
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Seoul, Korea, Republic of, 6351
- Samsung Medical Center
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Seoul, Korea, Republic of, 06591
- The Catholic University of Korea Seoul St. Mary's Hospital
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Seoul, Korea, Republic of, 03080
- Seoul Universtiy Hospital
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Hualien, Taiwan, 97002
- Hualien Tzu Chi Hospital
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Taipei city, Taiwan, 11217
- Taipei Veterans General Hospital
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Taipei city, Taiwan, 10002
- National Taiwan University Hospital
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Taoyuan, Taiwan, 33305
- Chang Gung Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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 |
Mirogabalin tablets for oral administration
Other Names:
|
Placebo Comparator: Placebo
Placebo (14-weeks)
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Matching placebo tablets for oral administration
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Daily Pain Score (ADPS)
Time Frame: Baseline to Week 14
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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.
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Baseline to Week 14
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Daily Pain Score (ADPS) Response Rate
Time Frame: at Week 14
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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.
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at Week 14
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Pain Intensity Score Using the Short-Form McGill Pain Questionnaire (SF-MPQ)
Time Frame: Baseline to Week 14
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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) |
Baseline to Week 14
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Patient Global Impression of Change
Time Frame: at Week 14
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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.
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at Week 14
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Average Daily Sleep Interference score (ADSIS)
Time Frame: Baseline to Week 14
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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.
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Baseline to Week 14
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DS5565-A-J314
- 194653 (Registry Identifier: JAPIC CTI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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