Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia
A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel, Fixed-Dose Study to Evaluate the Efficacy and Safety of MT-5199 for the Treatment in Patients With Tardive Dyskinesia (J-KINECT)
1 other identifier
interventional
256
1 country
82
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of MT-5199 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2017
Typical duration for phase_2
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2017
CompletedFirst Posted
Study publicly available on registry
June 5, 2017
CompletedStudy Start
First participant enrolled
June 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2020
CompletedResults Posted
Study results publicly available
August 14, 2023
CompletedJanuary 7, 2026
December 1, 2025
3.3 years
June 2, 2017
August 25, 2022
December 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Central Assessment) at Week 6
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded central AIMS raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.
Baseline and Week 6
Secondary Outcomes (3)
Percentage of Subjects With a ≥50% Improvement From Baseline in the AIMS Total Score (Central Assessment) at Week 6 (AIMS Responder)
Week 6
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Site Assessment) at Week 6
Baseline and Week 6
Clinical Global Impression of Change - TD (CGI-TD) Score at Week 6
Week 6
Study Arms (5)
MT-5199 40 mg (Double-Blind Placebo-Controlled Period)
EXPERIMENTALMT-5199 administered as one (1) 40 mg capsule and one (1) placebo capsule, taken by mouth, every morning for 6 weeks.
MT-5199 80 mg (Double-Blind Placebo-Controlled Period)
EXPERIMENTALSubjects 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.
Placebo (Double-Blind Placebo-Controlled Period)
EXPERIMENTALPlacebo administered as two (2) placebo capsules, taken by mouth, every morning for 6 weeks.
MT-5199 40 mg (Double-Blind Extension Period)
EXPERIMENTALAt 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 80 mg (Double-Blind Extension Period)
EXPERIMENTALAt 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.
Interventions
MT-5199 40 mg capsules
MT-5199 placebo capsules
Eligibility Criteria
You may qualify if:
- Have one of the following clinical diagnoses for at least 3 months prior to screening: Schizophrenia or Schizoaffective Disorder, Bipolar Disorder, or Depressive Disorders.
- 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.
You may not qualify if:
- Have an active, clinically significant unstable medical condition in screening period.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (82)
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
Related Publications (3)
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.
PMID: 36114799RESULTWatanabe 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.
PMID: 39186921DERIVEDNagano 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.
PMID: 38421921DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials, Information Desk
- Organization
- Tanabe Pharma Corporation
Study Officials
- STUDY DIRECTOR
General Manager
Tanabe Pharma Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2017
First Posted
June 5, 2017
Study Start
June 21, 2017
Primary Completion
September 29, 2020
Study Completion
September 29, 2020
Last Updated
January 7, 2026
Results First Posted
August 14, 2023
Record last verified: 2025-12