Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia
NCT ID: NCT03176771
Last Updated: 2026-01-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
256 participants
INTERVENTIONAL
2017-06-21
2020-09-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MT-5199 40 mg (Double-Blind Placebo-Controlled Period)
MT-5199 administered as one (1) 40 mg capsule and one (1) placebo capsule, taken by mouth, every morning for 6 weeks.
MT-5199
MT-5199 40 mg capsules
Placebo
MT-5199 placebo capsules
MT-5199 80 mg (Double-Blind Placebo-Controlled Period)
Subjects randomized to the MT-5199 80 mg dose will receive MT-5199 40 mg for the first week (administered as one (1) 40 mg capsule and one (1) placebo capsule), followed by MT-5199 80 mg administered as two (2) 40 mg capsules, taken by mouth, every morning for 5 weeks.
MT-5199
MT-5199 40 mg capsules
Placebo
MT-5199 placebo capsules
Placebo (Double-Blind Placebo-Controlled Period)
Placebo administered as two (2) placebo capsules, taken by mouth, every morning for 6 weeks.
Placebo
MT-5199 placebo capsules
MT-5199 40 mg (Double-Blind Extension Period)
At the end of Week 6, subjects will enter a double-blind extension period for 42 weeks. Subjects who were initially randomized to placebo will be re-randomized (1:1) to receive either MT-5199 40 mg or 80 mg and subjects initially randomized to MT-5199 will continue with their current dose.
MT-5199
MT-5199 40 mg capsules
Placebo
MT-5199 placebo capsules
MT-5199 80 mg (Double-Blind Extension Period)
At the end of Week 6, subjects will enter a double-blind extension period for 42 weeks. Subjects who were initially randomized to placebo will be re-randomized (1:1) to receive either MT-5199 40 mg or 80 mg and subjects initially randomized to MT-5199 will continue with their current dose. Subjects re-randomized to receive MT-5199 80 mg will receive 40 mg for the first week.
MT-5199
MT-5199 40 mg capsules
Placebo
MT-5199 placebo capsules
Interventions
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MT-5199
MT-5199 40 mg capsules
Placebo
MT-5199 placebo capsules
Eligibility Criteria
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Inclusion Criteria
* Have a clinical diagnosis of neuroleptic-induced TD.
* Have moderate or severe TD.
* If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or bipolar disorder, or depressive disorders, be on stable doses.
Exclusion Criteria
* Have a significant risk of suicidal or violent behavior.
* Have a known history of long QT syndrome or cardiac tachy-arrhythmia.
* Are currently pregnant or breastfeeding.
20 Years
85 Years
ALL
No
Sponsors
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Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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General Manager
Role: STUDY_DIRECTOR
Tanabe Pharma Corporation
Locations
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Aichi Psychiatric Medical Center
Aichi, , Japan
Hotei Hospital
Aichi, , Japan
Mikawa Hospital
Aichi, , Japan
Okehazama Hospital Fujita Kokoro Care Center
Aichi, , Japan
Akita City Hospital
Akita, , Japan
Akita University Hospital
Akita, , Japan
Hirosaki Aiseikai Hospital
Aomori, , Japan
Minato Hospital
Aomori, , Japan
Seinan Hospital
Aomori, , Japan
Kohnodai Hospital , National Center for Global Health and Medicine
Chiba, , Japan
National Hospital Organization Shimofusa Psychiatric Medical Center
Chiba, , Japan
General incorporated association Shinkoukai Shinkouen
Ehime, , Japan
Chikusuikai Hospital
Fukuoka, , Japan
Fukuoka University Hospital
Fukuoka, , Japan
Hirota Clinic
Fukuoka, , Japan
Iizukakinen Hospital
Fukuoka, , Japan
Kuramitsu Hospital
Fukuoka, , Japan
Minamigaoka Hospital
Fukuoka, , Japan
Yahata Kousei Hospital
Fukuoka, , Japan
Nanko Kokorono Clinic
Fukushima, , Japan
Takeda General Hospital
Fukushima, , Japan
Holy Cross Hospital
Gifu, , Japan
Seimou Hospital
Gunma, , Japan
Hayakawa Clinic
Hiroshima, , Japan
Kamo Psychiatric Center
Hiroshima, , Japan
Medical corporation KOSEIKAI KUSATSU HOSPITAL
Hiroshima, , Japan
Mihara Hospital
Hiroshima, , Japan
Hayashishita Hospital
Hokkaido, , Japan
Ishikane Hospital
Hokkaido, , Japan
National Hospital Organization Hokkaido Medical Center
Hokkaido, , Japan
Obihiro-Kosei General Hospital
Hokkaido, , Japan
Sapporo City General Hospital
Hokkaido, , Japan
Teine Hospital
Hokkaido, , Japan
Hyogo prefecture - Hyogo Mental Health Center
Hyōgo, , Japan
Kobe University Hospital
Hyōgo, , Japan
Medical corporation Shouhokai Toda Internal Medicine and Rehabilitation Department
Hyōgo, , Japan
Awazu Neuropsychiatric Sanatorium
Ishikawa, , Japan
Ishiki Hospital
Kagoshima, , Japan
Minami Kyushu Sakura Hospital
Kagoshima, , Japan
Taniyama Hospital
Kagoshima, , Japan
Fujimidai Hospital
Kanagawa, , Japan
Hatano Kosei Hospital
Kanagawa, , Japan
Hino Hospital
Kanagawa, , Japan
Kishiro Mental Clinic
Kanagawa, , Japan
Kitaodawara Hospital Meihoukai Medical Corporation Association
Kanagawa, , Japan
Shiunkai Yokohama Hospital
Kanagawa, , Japan
Soushu Hospital
Kanagawa, , Japan
Yatsushirokosei Hospital
Kumamoto, , Japan
Yuge Hospital
Kumamoto, , Japan
Sagaarashiyama Tanaka Clinic
Kyoto, , Japan
Miyagi Psychiatric Center
Miyagi, , Japan
Yasuda Hospital
Miyagi, , Japan
National Hospital Organization Komoro kogen Hospital
Nagano, , Japan
North Alps Medical Center Azumi Hospital
Nagano, , Japan
Syonan Hospital
Nagano, , Japan
Sanwa Central Hospital
Nagasaki, , Japan
Nara Medical University Hospital
Nara, , Japan
Akari Clinic
Okinawa, , Japan
Arakaki Hospital
Okinawa, , Japan
Samariya Hospital
Okinawa, , Japan
Keihan Hospital
Osaka, , Japan
Kyowakai Healthcare Corpration Hannan Hospital
Osaka, , Japan
Hoaki Hospital
Ōita, , Japan
Hizen Psychiatric Center
Saga, , Japan
Rainbow & Sea Hospital
Saga, , Japan
Sho Midori Hospital
Saitama, , Japan
Shiga University of Medical Science Hospital
Shiga, , Japan
Shimane University Hospital
Shimane, , Japan
Numazu Chuo Hospital
Shizuoka, , Japan
Abe Clinic
Tokyo, , Japan
Hozumi Clinic
Tokyo, , Japan
Kyorin University Hospital
Tokyo, , Japan
Maynds Tower Mental Clinic
Tokyo, , Japan
National Center of Neurology and Psychiatry
Tokyo, , Japan
Nishigahara Hospital
Tokyo, , Japan
Ongata Hospital
Tokyo, , Japan
Sangenjaya Neurology-Psychosomatic Clinic
Tokyo, , Japan
Senzoku Mental Clinic
Tokyo, , Japan
Kawada Hospital
Toyama, , Japan
Minamitoyama Nakagawa Hospital
Toyama, , Japan
Public Okitama General Hospital
Yamagata, , Japan
National Hospital Organization Kanmon Medical Center
Yamaguchi, , Japan
Countries
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References
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Horiguchi J, Watanabe K, Kondo K, Iwatake A, Sakamoto H, Susuta Y, Masui H, Watanabe Y. Efficacy and safety of valbenazine in Japanese patients with tardive dyskinesia: A multicenter, randomized, double-blind, placebo-controlled study (J-KINECT). Psychiatry Clin Neurosci. 2022 Nov;76(11):560-569. doi: 10.1111/pcn.13455. Epub 2022 Sep 17.
Watanabe Y, Susuta Y, Nagano M, Masui H, Kanahara N. Efficacy and Safety of Valbenazine in Elderly and Nonelderly Japanese Patients With Tardive Dyskinesia: A Post Hoc Analysis of the J-KINECT Study. J Clin Psychopharmacol. 2024 Nov-Dec;44(6):551-560. doi: 10.1097/JCP.0000000000001903. Epub 2024 Aug 27.
Nagano M, Susuta Y, Masui H, Watanabe Y, Watanabe K. Efficacy and Safety of Valbenazine in Japanese Patients With Tardive Dyskinesia and Schizophrenia/Schizoaffective Disorder or Bipolar Disorder/Depressive Disorder: Primary Results and Post Hoc Analyses of the J-KINECT Study. J Clin Psychopharmacol. 2024 Mar-Apr 01;44(2):107-116. doi: 10.1097/JCP.0000000000001811.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MT-5199-J02
Identifier Type: -
Identifier Source: org_study_id
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