Efficacy and Safety of MT-5199 in Subjects With Tardive D... | NCT03176771 | Trialant
NCT03176771
Sponsor
Tanabe Pharma Corporation
Status
Completed
Last Update Posted
Jan 7, 2026Actual
Enrollment
256Actual
Phase
Phase 2Phase 3
Conditions
Tardive Dyskinesia
Interventions
MT-5199
Placebo
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT03176771
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MT-5199-J02
Secondary IDs
Not provided
Brief Title
Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia
Official Title
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)
Acronym
Not provided
Organization
Tanabe Pharma CorporationINDUSTRY
Status Module
Record Verification Date
Dec 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 21, 2017Actual
Primary Completion Date
Sep 29, 2020Actual
Completion Date
Sep 29, 2020Actual
First Submitted Date
Jun 2, 2017
First Submission Date that Met QC Criteria
Jun 2, 2017
First Posted Date
Jun 5, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Aug 25, 2022
Results First Submitted that Met QC Criteria
Aug 8, 2023
Results First Posted Date
Aug 14, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 15, 2025
Last Update Posted Date
Jan 7, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Tanabe Pharma CorporationINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
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.
Drug: MT-5199
Drug: Placebo
Placebo (Double-Blind Placebo-Controlled Period)
Experimental
Placebo administered as two (2) placebo capsules, taken by mouth, every morning for 6 weeks.
Drug: Placebo
MT-5199 40 mg (Double-Blind Extension Period)
Experimental
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.
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
Measure
Description
Time Frame
Percentage of Subjects With a ≥50% Improvement From Baseline in the AIMS Total Score (Central Assessment) at Week 6 (AIMS Responder)
Percentage of AIMS responders (subjects who had at least a 50 percent reduction in AIMS score from baseline)
Week 6
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Site Assessment) at Week 6
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
This study enrolled schizophrenia/schizoaffective disorder subject with tardive dyskinesia (TD), or bipolar disorder/depressive disorder with TD from 100 centers in Japan.The last patient completed in September 2020.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo (Double-Blind Placebo-Controlled Period)
Subjects who were randomized to receive Placebo capsule once daily for 6 weeks.
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.
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded site 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
Clinical Global Impression of Change - TD (CGI-TD) Score at Week 6
Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).
Week 6
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
Derived
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.
Subjects who were randomized to receive MT-5199 (Valbenazine) 40 mg capsule once daily for 6 weeks.
Subjects who were randomized to receive MT-5199 (Valbenazine) 40 mg capsule once daily for 1 weeks, then 80 mg capsule once daily for 5 weeks.
FG003
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 (Valbenazine) 40 mg or 80 mg and subjects initially randomized to MT-5199 (Valbenazine) will continue with their current dose.
FG004
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 (Valbenazine) 40 mg or 80 mg and subjects initially randomized to MT-5199 (Valbenazine) will continue with their current dose. Subjects re-randomized to receive MT-5199 (Valbenazine) 80 mg will receive 40 mg for the first week.
FG00085 subjects
FG00186 subjects
FG00285 subjects
FG0030 subjects
FG0040 subjects
COMPLETED
FG00080 subjects
FG00171 subjects
FG00260 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG0005 subjects
FG00115 subjects
FG00225 subjects
FG0030 subjects
FG0040 subjects
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0015 subjects
FG00214 subjects
FG0030 subjects
FG0040 subjects
Physician Decision
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0018 subjects
FG00210 subjects
FG0030 subjects
FG004
Incorrect allocation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Double-Blind Extension Period
Type
Comment
Milestone Data
STARTED
FG0000 subjectsOf the 80 placebo subjects who remained in the study at Week 6, 41 were re-randomized to MT-5199 40 mg (Double-Blind Extension Period) and 39 were re-randomized to MT-5199 80 mg (Double-Blind Extension Period).
FG0010 subjectsAll MT-5199 40 mg 71 subjects who completed Double-Blind Placebo-Controlled Period entered to MT-5199 40 mg Double-Blind Extension Period.
FG0020 subjectsAll MT-5199 80 mg 60 subjects who completed Double-Blind Placebo-Controlled Period entered to MT-5199 80 mg Double-Blind Extension Period.
FG003112 subjectsOf the 112 subject who entered the MT-5199 40 mg (Double-Blind Extension Period), 41 were previously in the placebo group and 71 were in the 40 mg group during the Double-Blind Placebo-Controlled Period.
FG00499 subjectsOf the 99 subjects who entered the MT-5199 80 mg (Double-Blind Extension Period), 39 were previously in the placebo group and 60 were in the 80 mg group during the Double-Blind Placebo-Controlled Period.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00367 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00345 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Safety analysis set
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo (Double-Blind Placebo-Controlled Period)
Subjects received Placebo capsule (matching MT-5199 capsules) once daily for 6 weeks.
Subjects received MT-5199 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00084
BG00185
BG00284
BG003253
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00060.0± 13.4
BG00158.6± 14.0
BG00258.0± 13.8
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00048
BG00145
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Japanese
Title
Measurements
BG00084
BG00185
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
The analysis population (80 in the placebo, 68 in the MT-5199 40 mg, and 57 in the MT-5199 80 mg) consisted of subjects who satisfy all of the following conditions:
Subjects in the ITT analysis set
Subjects for whom the Week 6 AIMS total score (central assessment) is available
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Baseline and Week 6
ID
Title
Description
OG000
Placebo (Double-Blind Placebo-Controlled Period)
Subjects received Placebo capsule (matching MT-5199 capsules) once daily for 6 weeks.
Subjects received MT-5199 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
Units
Counts
Participants
OG00080
OG00168
OG00257
Title
Denominators
Categories
Title
Measurements
OG000-0.1(-0.8 to 0.5)
OG001-2.3(-3.0 to -1.7)
OG002-3.7(-4.4 to -3.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Control for multiplicity was accomplished through the a fixed-sequence testing procedure for Week 6 outcomes:
AIMS dyskinesia total score mean change from baseline (CFB): MT-5199 80 mg vs. placebo.
AIMS: MT-5199 40 mg vs. PBO. For a test result in the above list to be considered statistically significant, all of the test results higher in the list must have been significant at the 0.05 level of significance.
Mixed-effect Model Repeated Measures
<0.001
Mean Difference (Final Values)
-3.6
Standard Error of the Mean
0.5
2-Sided
95
-4.5
-2.6
Superiority
Secondary
Percentage of Subjects With a ≥50% Improvement From Baseline in the AIMS Total Score (Central Assessment) at Week 6 (AIMS Responder)
Percentage of AIMS responders (subjects who had at least a 50 percent reduction in AIMS score from baseline)
The analysis population (78 in the placebo, 67 in the MT-5199 40 mg, and 53 in the MT-5199 80 mg) consisted of subjects who satisfy all of the following conditions:
Subjects in the ITT analysis set
Subjects for whom the Week 6 AIMS total score (central assessment) is available and the baseline AIMS total score (central assessment) is not zero
Posted
Number
percentage of AIMS responders
Week 6
ID
Title
Description
OG000
Placebo (Double-Blind Placebo-Controlled Period)
Subjects received Placebo capsule (matching MT-5199 capsules) once daily for 6 weeks.
Subjects received MT-5199 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
Secondary
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Site Assessment) at Week 6
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded site 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.
The analysis population (80 in the placebo, 68 in the MT-5199 40 mg, and 57 in the MT-5199 80 mg) consisted of subjects who satisfy all of the following conditions:
Subjects in the ITT analysis set
Subjects for whom the Week 6 AIMS total score (site assessment) is available
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Baseline and Week 6
ID
Title
Description
OG000
Placebo (Double-Blind Placebo-Controlled Period)
Subjects received Placebo capsule (matching MT-5199 capsules) once daily for 6 weeks.
Clinical Global Impression of Change - TD (CGI-TD) Score at Week 6
Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).
The analysis population (80 in the placebo, 70 in the MT-5199 40 mg, and 60 in the MT-5199 80 mg) consisted of subjects who satisfy all of the following conditions:
Subjects in the ITT analysis set
Subjects for whom the Week 6 CGI-TD score is available
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Week 6
ID
Title
Description
OG000
Placebo (Double-Blind Placebo-Controlled Period)
Subjects received Placebo capsule (matching MT-5199 capsules) once daily for 6 weeks.
Subjects received MT-5199 40 mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
0
84
1
84
44
84
EG003
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.
3
108
15
108
71
108
EG004
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.