Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2019-03-12
2020-12-28
Brief Summary
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Detailed Description
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\[Open Extension Phase\] 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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
During the Open Extension Phase, all participants will be assigned to a single group.
TREATMENT
TRIPLE
Study Groups
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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
Mirogabalin tablets for oral administration
Placebo
Placebo (14-weeks)
Placebo
Matching placebo tablets for oral administration
Interventions
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Placebo
Matching placebo tablets for oral administration
Mirogabalin
Mirogabalin tablets for oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* American Spinal Injury Association impairment scale A, B, C, or D
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Daiichi Sankyo Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Study Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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Chubu-Rosai Hospital
Aichi, , Japan
Social Medical Corporation Daido Clinic
Aichi, , Japan
Honmachi Clinic
Aichi, , Japan
Nagoya City West Medical Center
Aichi, , Japan
Toyota Kosei Hospital
Aichi, , Japan
Nagoya Tokushukai General Hospital
Aichi, , Japan
Kainan Hospital
Aichi, , Japan
Hachinohe City Hospital
Aomori, , Japan
Hirosaki University Hospital
Aomori, , Japan
Chiba University Hospital
Chiba, , Japan
Chiba Rehabilitation Center
Chiba, , Japan
Funabashi Municipal Medical Center
Chiba, , Japan
Kimitsu Chuo Hospital
Chiba, , Japan
Ehime Prefectural Central Hospital
Ehime, , Japan
University of Fukui Hospital
Fukui, , Japan
Fukui-ken Saiseikai Hospital
Fukui, , Japan
Shin Komonji Hospital
Fukuoka, , Japan
Kyushu Rosai Hospital
Fukuoka, , Japan
Steel Memorial Yawata Hospital
Fukuoka, , Japan
Go Neurosurgical Clinic
Fukuoka, , Japan
Japan Organization of Occupational Health and Safety Spinal Injuries Center
Fukuoka, , Japan
Shin Yukuhashi Hospital
Fukuoka, , Japan
Fukushima Medical University Hospital
Fukushima, , Japan
Southern TOHOKU Medical Clinic
Fukushima, , Japan
Japanese Red Cross Maebashi Hospital
Gunma, , Japan
Goodlife Hospital
Hiroshima, , Japan
Medical Corporation Suiseikai Suiseikai Kajikawa Hospital
Hiroshima, , Japan
Hiroshima City Asa Citizens Hospital
Hiroshima, , Japan
Hiroshima Prefectural Hospital
Hiroshima, , Japan
Teine Keijinkai Hospital
Hokkaido, , Japan
Hakodate Municipal Hospital
Hokkaido, , Japan
Sapporo Medical University Hospital
Hokkaido, , Japan
Nakamura Memorial Hospital
Hokkaido, , Japan
Sapporo City General Hospital
Hokkaido, , Japan
Japanese Red Cross Asahikawa Hospital
Hokkaido, , Japan
Hokkaido Spinal Cord Injury Center
Hokkaido, , Japan
Kobe City Medical Center General Hospital
Hyōgo, , Japan
Japanese Red Cross Kobe Hospital
Hyōgo, , Japan
Hyogo Social Welfare Corporation Hyogo Rehabilitation Center Central Hospital
Hyōgo, , Japan
Japanese Red Cross Society Himeji Hospital
Hyōgo, , Japan
University of Tsukuba Hospital
Ibaraki, , Japan
Ibaraki Seinan Medical Center Hospital
Ibaraki, , Japan
Ishikawa Prefectural Central Hospital
Ishikawa, , Japan
Kagawa Prefectural Central Hospital
Kagawa, , Japan
Shikoku Medical Center for Children and Adults
Kagawa, , Japan
Japan Organization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital
Kanagawa, , Japan
Yokohama City Minato Red Cross Hospital
Kanagawa, , Japan
Yokohama City University Hospital
Kanagawa, , Japan
Kanagawa Rehabilitation Hospital
Kanagawa, , Japan
Sagamihara Kyodo Hospital
Kanagawa, , Japan
National Hospital Organaization Kumamoto Medical Center
Kumamoto, , Japan
Kumamoto Kinoh Hospital
Kumamoto, , Japan
Kumamoto Takumadai Rehabilitation Hospital
Kumamoto, , Japan
Kumamoto Rehabilitation Hospital
Kumamoto, , Japan
Uji-Tokushukai Medical Center
Kyoto, , Japan
Mie University Hospital
Mie, , Japan
Tohoku Rosai Hospital
Miyagi, , Japan
National Hospital Organization Sendai Medical Center
Miyagi, , Japan
Katta General Hospital
Miyagi, , Japan
Junwakai Memorial Hospital
Miyazaki, , Japan
University of Miyazaki Hospital
Miyazaki, , Japan
Japan Red Cross Society Azumino Hospital
Nagano, , Japan
Nagasaki University Hospital
Nagasaki, , Japan
Nagasaki Rosai Hospital
Nagasaki, , Japan
Nara Prefecture General Rehabilitation Center
Nara, , Japan
Japanese Red Cross Society Nagaoka Red Cross Hospital
Niigata, , Japan
Nagaoka Chuo General Hospital
Niigata, , Japan
Niigata City General Hospital
Niigata, , Japan
Niigata University Medical & Dental Hospital
Niigata, , Japan
Iwate Rehabilitation Center
Numakunai, , Japan
Okayama City General Medical Center Okayama City Hospital
Okayama, , Japan
Kibikogen Rehabilitation Center For Employment Injuries
Okayama, , Japan
Medical Corporation Tapic Okinawa Rehabilitation Center Hospital
Okinawa, , Japan
Osaka General Medical Center
Osaka, , Japan
Osaka University Hospital
Osaka, , Japan
Aijinkai Rehabilitation Hospital
Osaka, , Japan
Osaka Rosai Hospital
Osaka, , Japan
Medical Corporation Keiaikai Nakamura Hospital
Ōita, , Japan
Saga-ken Medical Centre KOSEIKAN
Saga, , Japan
Hanyu General Hospital
Saitama, , Japan
Otsu City Hospital
Shiga, , Japan
Saiseikai Shiga Hospital
Shiga, , Japan
Shimane University Hospital
Shimane, , Japan
Shizuoka City Shimizu Hospital
Shizuoka, , Japan
Fujieda Municipal General Hospital
Shizuoka, , Japan
Hamamatsu University Hospital
Shizuoka, , Japan
Japanese Red Cross Hamamatsu Hospital
Shizuoka, , Japan
Kikugawa General Hospital
Shizuoka, , Japan
Dokkyo Medical University Hospital
Tochigi, , Japan
Jichi Medical University Hospital
Tochigi, , Japan
Tokushima University Hospital
Tokushima, , Japan
Makita General Hospital
Tokyo, , Japan
Nihon University Itabashi Hospital
Tokyo, , Japan
National Hospital Organaization Murayama Medical Center
Tokyo, , Japan
Tottori University Hospital
Tottori, , Japan
Toyama University Hospital Hospital
Toyama, , Japan
Wakayama Medical University Hospital
Wakayama, , Japan
Sanyudo Rehabilitation Center
Yamagata, , Japan
Yamaguchi University Hospital
Yamaguchi, , Japan
Yamaguchi Rosai Hospital
Yamaguchi, , Japan
Yamanashi Prefectural Central Hospital
Yamanashi, , Japan
Daegu Fatima Hospital
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
CHA Bundang Medical Center
Gyeonggi-do, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
The Catholic University of Korea St. Vincent's Hospital
Gyeonggi-do, , South Korea
Ajou University Hospital
Gyeonggi-do, , South Korea
The Catholic University of Korea Incheon St. Mary's Hospital
Gyeonggi-do, , South Korea
Chonbuk National University Hospital
Jeollabuk-do, , South Korea
Pusan National University Hospital
Pusan, , South Korea
Pusan National University Yangsan Hospital
Pusan, , South Korea
Seoul Universtiy Hospital
Seoul, , South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hualien Tzu Chi Hospital
Hualien City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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References
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Hosomi K, Katayama Y, Sakoda H, Kikumori K, Kuroha M, Ushida T. Usefulness of Mirogabalin in Central Neuropathic Pain After Stroke: Post Hoc Analysis of a Phase 3 Study by Stroke Type and Location. Pain Ther. 2024 Oct;13(5):1151-1171. doi: 10.1007/s40122-024-00616-3. Epub 2024 Jul 4.
Ushida T, Katayama Y, Hiasa Y, Nishihara M, Tajima F, Katoh S, Tanaka H, Maeda T, Furusawa K, Kakehi Y, Kikumori K, Kuroha M. Long-Term Safety and Efficacy of Mirogabalin for Central Neuropathic Pain: A Multinational, Phase 3, 52-Week, Open-Label Study in Asia. Pain Ther. 2023 Aug;12(4):963-978. doi: 10.1007/s40122-023-00513-1. Epub 2023 Apr 28.
Ushida T, Katayama Y, Hiasa Y, Nishihara M, Tajima F, Katoh S, Tanaka H, Maeda T, Furusawa K, Richardson M, Kakehi Y, Kikumori K, Kuroha M. Mirogabalin for Central Neuropathic Pain After Spinal Cord Injury: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study in Asia. Neurology. 2023 Mar 14;100(11):e1193-e1206. doi: 10.1212/WNL.0000000000201709. Epub 2022 Dec 14.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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194653
Identifier Type: REGISTRY
Identifier Source: secondary_id
DS5565-A-J314
Identifier Type: -
Identifier Source: org_study_id