Tardive DyskinesiaPhase 2/3NCT03176771

Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia

A Phase 2/3 study testing MT-5199 in people with Tardive Dyskinesia, run by Tanabe Pharma Corporation at 82 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 20 to 85 years
Conditions the study is for: Tardive Dyskinesia
What is being tested?: MT-5199
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 256 participants
Where: 82 sitesJapan
Study dates: 21 Jun 2017to 29 Sep 2020
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

82 sites in 1 country.

City, postcode or hospital

82 sites in 1 country

Japan82 sites

Aichi Psychiatric Medical Center
Aichi
Hotei Hospital
Aichi
Mikawa Hospital
Aichi
Okehazama Hospital Fujita Kokoro Care Center
Aichi
Akita City Hospital
Akita
Akita University Hospital
Akita
Hirosaki Aiseikai Hospital
Aomori
Minato Hospital
Aomori
Seinan Hospital
Aomori
Kohnodai Hospital , National Center for Global Health and Medicine
Chiba
National Hospital Organization Shimofusa Psychiatric Medical Center
Chiba
General incorporated association Shinkoukai Shinkouen
Ehime
Chikusuikai Hospital
Fukuoka
Fukuoka University Hospital
Fukuoka
Hirota Clinic
Fukuoka
Iizukakinen Hospital
Fukuoka
Kuramitsu Hospital
Fukuoka
Minamigaoka Hospital
Fukuoka
Yahata Kousei Hospital
Fukuoka
Nanko Kokorono Clinic
Fukushima
Takeda General Hospital
Fukushima
Holy Cross Hospital
Gifu
Seimou Hospital
Gunma
Hayakawa Clinic
Hiroshima
Kamo Psychiatric Center
Hiroshima
Medical corporation KOSEIKAI KUSATSU HOSPITAL
Hiroshima
Mihara Hospital
Hiroshima
Hayashishita Hospital
Hokkaido
Ishikane Hospital
Hokkaido
National Hospital Organization Hokkaido Medical Center
Hokkaido
Obihiro-Kosei General Hospital
Hokkaido
Sapporo City General Hospital
Hokkaido
Teine Hospital
Hokkaido
Hyogo prefecture - Hyogo Mental Health Center
Hyōgo
Kobe University Hospital
Hyōgo
Medical corporation Shouhokai Toda Internal Medicine and Rehabilitation Department
Hyōgo
Awazu Neuropsychiatric Sanatorium
Ishikawa
Ishiki Hospital
Kagoshima
Minami Kyushu Sakura Hospital
Kagoshima
Taniyama Hospital
Kagoshima
Fujimidai Hospital
Kanagawa
Hatano Kosei Hospital
Kanagawa
Hino Hospital
Kanagawa
Kishiro Mental Clinic
Kanagawa
Kitaodawara Hospital Meihoukai Medical Corporation Association
Kanagawa
Shiunkai Yokohama Hospital
Kanagawa
Soushu Hospital
Kanagawa
Yatsushirokosei Hospital
Kumamoto
Yuge Hospital
Kumamoto
Sagaarashiyama Tanaka Clinic
Kyoto
Miyagi Psychiatric Center
Miyagi
Yasuda Hospital
Miyagi
National Hospital Organization Komoro kogen Hospital
Nagano
North Alps Medical Center Azumi Hospital
Nagano
Syonan Hospital
Nagano
Sanwa Central Hospital
Nagasaki
Nara Medical University Hospital
Nara
Hoaki Hospital
Ōita
Akari Clinic
Okinawa
Arakaki Hospital
Okinawa
Samariya Hospital
Okinawa
Keihan Hospital
Osaka
Kyowakai Healthcare Corpration Hannan Hospital
Osaka
Hizen Psychiatric Center
Saga
Rainbow & Sea Hospital
Saga
Sho Midori Hospital
Saitama
Shiga University of Medical Science Hospital
Shiga
Shimane University Hospital
Shimane
Numazu Chuo Hospital
Shizuoka
Abe Clinic
Tokyo
Hozumi Clinic
Tokyo
Kyorin University Hospital
Tokyo
Maynds Tower Mental Clinic
Tokyo
National Center of Neurology and Psychiatry
Tokyo
Nishigahara Hospital
Tokyo
Ongata Hospital
Tokyo
Sangenjaya Neurology-Psychosomatic Clinic
Tokyo
Senzoku Mental Clinic
Tokyo
Kawada Hospital
Toyama
Minamitoyama Nakagawa Hospital
Toyama
Public Okitama General Hospital
Yamagata
National Hospital Organization Kanmon Medical Center
Yamaguchi

Other trials in Japan

About this study

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)

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.

Conditions: Tardive Dyskinesia
Being tested: MT-5199, Placebo
Medical subject headings: Tardive Dyskinesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MT-5199Drug
MT-5199 40 mg capsules
PlaceboDrug
MT-5199 placebo capsules

Study groups in NCT03176771
Study group	Role	What they receive
MT-5199 40 mg (Double-Blind Placebo-Controlled Period)	Experimental	MT-5199 administered as one (1) 40 mg capsule and one (1) placebo capsule, taken by mouth, every morning for 6 weeks. Receives: Drug: MT-5199; Drug: Placebo
MT-5199 80 mg (Double-Blind Placebo-Controlled Period)	Experimental	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. Receives: 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. Receives: 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. Receives: Drug: MT-5199; Drug: Placebo
MT-5199 80 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. Subjects re-randomized to receive MT-5199 80 mg will receive 40 mg for the first week. Receives: Drug: MT-5199; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
Percentage of AIMS responders (subjects who had at least a 50 percent reduction in AIMS score from baseline)
Measured: Week 6
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.
Measured: 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).
Measured: Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jun 201729 Sep 2020

First posted5 Jun 2017
Study start21 Jun 2017
Primary completion29 Sep 2020
Study completion29 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Tardive DyskinesiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 256 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03176771
Sponsor's protocol ID: MT-5199-J02
Status last verified: Dec 2025
First submitted: 2 Jun 2017
Last updated: 7 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 36114799
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.
PubMed 39186921
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.
PubMed 38421921

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
Schizophrenia, Schizoaffective Disorder
Not yet recruitingObservational study
A Computer-Assisted Tool for Objective Assessment of Extrapyramidal Symptoms
Extrapyramidal Symptoms, Drug-induced Parkinsonism
RecruitingPhase 4
Deutetrabenazine Treatment for Tardive Dyskinesia in Intellectual/Developmental Disabilities
Tardive Dyskinesia, Intellectual Disability
RecruitingPhase 2
Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia
Tardive Dyskinesia
Recruiting
Single-Center, Double-Blind, Randomized, Placebo-Controlled Study on Efficacy and Safety of rTMS (With Precise Localization) in Relieving Motor Symptoms of TD
Tardive Dyskinesia, Repetitive Transcranial Magnetic Stimulation

All Tardive Dyskinesia trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT03176771
Acronym / sponsor ID: MT-5199-J02
Conditions: Tardive Dyskinesia
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 256 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: 21 Jun 2017 (actual)
Primary completion: 29 Sep 2020 (actual)
Study completion: 29 Sep 2020 (actual)
First posted: 5 Jun 2017 (actual)
Results: Posted 14 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
MT-5199 40 mg (Double-Blind Placebo-Controlled Period)	Experimental	Drug: MT-5199, Drug: PlaceboMT-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)	Experimental	Drug: MT-5199, Drug: PlaceboSubjects 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)	Experimental	Drug: PlaceboPlacebo administered as two (2) placebo capsules, taken by mouth, every morning for 6 weeks.
MT-5199 40 mg (Double-Blind Extension Period)	Experimental	Drug: MT-5199, Drug: PlaceboAt 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)	Experimental	Drug: MT-5199, Drug: PlaceboAt 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.

Who may qualify

Ages: 20 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MT-5199MT-5199 40 mg capsules	Drug	MT-5199 40 mg (Double-Blind Extension Period), MT-5199 40 mg (Double-Blind Placebo-Controlled Period), MT-5199 80 mg (Double-Blind Extension Period), MT-5199 80 mg (Double-Blind Placebo-Controlled Period)
PlaceboMT-5199 placebo capsules	Drug	MT-5199 40 mg (Double-Blind Extension Period), MT-5199 40 mg (Double-Blind Placebo-Controlled Period), MT-5199 80 mg (Double-Blind Extension Period), MT-5199 80 mg (Double-Blind Placebo-Controlled Period), Placebo (Double-Blind Placebo-Controlled Period)

Primary outcome

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Central Assessment) at Week 6
Time frame: Baseline and 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.

3 secondary outcomes

Percentage of Subjects With a ≥50% Improvement From Baseline in the AIMS Total Score (Central Assessment) at Week 6 (AIMS Responder)
Time frame: Week 6
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Site Assessment) at Week 6
Time frame: Baseline and Week 6
Clinical Global Impression of Change - TD (CGI-TD) Score at Week 6
Time frame: Week 6

Results and safety

Results posted to the registry on 14 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo (Double-Blind Placebo-Controlled Period)	85	80
MT-5199 40 mg (Double-Blind Placebo-Controlled Period)	86	71
MT-5199 80 mg (Double-Blind Placebo-Controlled Period)	85	60
MT-5199 40 mg (Double-Blind Extension Period)	0	0
MT-5199 80 mg (Double-Blind Extension Period)	0	0

Primary outcome: Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Central Assessment) at Week 6

Time frame: Baseline and Week 6. Least squares mean (95% Confidence Interval). Unit: units on a scale

Measure	Placebo (Double-Blind Placebo-Controlled Period) n = 80	MT-5199 40 mg (Double-Blind Placebo-Controlled Period) n = 68	MT-5199 80 mg (Double-Blind Placebo-Controlled Period) n = 57
Value	-0.1 (-0.8 to 0.5)	-2.3 (-3.0 to -1.7)	-3.7 (-4.4 to -3.0)

Placebo (Double-Blind Placebo-Controlled Period) vs MT-5199 80 mg (Double-Blind Placebo-Controlled Period): Mean Difference (Final Values): -3.6 (95% CI -4.5 to -2.6), p <0.001, Mixed-effect Model Repeated Measures
Placebo (Double-Blind Placebo-Controlled Period) vs MT-5199 40 mg (Double-Blind Placebo-Controlled Period): Median Difference (Final Values): -2.2 (95% CI -3.0 to -1.3), p <0.001, Mixed-effect Model Repeated Measures

Population analysed: 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

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Double-Blind Placebo-Controlled Period)	1 of 84 (1.2%)	15 of 84 (17.9%)	0 of 84
MT-5199 40 mg (Double-Blind Placebo-Controlled Period)	4 of 85 (4.7%)	30 of 85 (35.3%)	0 of 85
MT-5199 80 mg (Double-Blind Placebo-Controlled Period)	1 of 84 (1.2%)	44 of 84 (52.4%)	0 of 84
MT-5199 40 mg (Double-Blind Extension Period)	15 of 108 (13.9%)	71 of 108 (65.7%)	3 of 108
MT-5199 80 mg (Double-Blind Extension Period)	15 of 95 (15.8%)	69 of 95 (72.6%)	4 of 95

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 36114799Horiguchi 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.
Derived from this study: PubMed 39186921Watanabe 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.
Derived from this study: PubMed 38421921Nagano 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.

Related trials for Tardive Dyskinesia

RecruitingPhase 4
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
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Not yet recruitingObservational study
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Single-Center, Double-Blind, Randomized, Placebo-Controlled Study on Efficacy and Safety of rTMS (With Precise Localization) in Relieving Motor Symptoms of TD
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

General Manager study director

Tanabe Pharma Corporation

82 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing MT-5199 in people with Tardive Dyskinesia, run by Tanabe Pharma Corporation at 82 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Central Assessment) at Week 6 (time frame: Baseline and Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03176771, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.