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)

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 Overview

• Status: Completed
• Conditions: Tardive Dyskinesia
• Intervention / Treatment: Drug: MT-5199; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Japan
  • Aichi, Japan
    • Aichi Psychiatric Medical Center
  • Aichi, Japan
    • Hotei Hospital
  • Aichi, Japan
    • Mikawa Hospital
  • Aichi, Japan
    • Okehazama Hospital Fujita Kokoro Care Center
  • Akita, Japan
    • Akita City Hospital
  • Akita, Japan
    • Akita University Hospital
  • Aomori, Japan
    • Hirosaki Aiseikai Hospital
  • Aomori, Japan
    • Minato Hospital
  • Aomori, Japan
    • Seinan Hospital
  • Chiba, Japan
    • Kohnodai Hospital , National Center for Global Health and Medicine
  • Chiba, Japan
    • National Hospital Organization Shimofusa Psychiatric Medical Center
  • Ehime, Japan
    • General incorporated association Shinkoukai Shinkouen
  • Fukuoka, 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
  • Fukushima, Japan
    • Nanko Kokorono Clinic
  • Fukushima, Japan
    • Takeda General Hospital
  • Gifu, Japan
    • Holy Cross Hospital
  • Gunma, Japan
    • Seimou Hospital
  • Hiroshima, Japan
    • Hayakawa Clinic
  • Hiroshima, Japan
    • Kamo Psychiatric Center
  • Hiroshima, Japan
    • Medical corporation KOSEIKAI KUSATSU HOSPITAL
  • Hiroshima, Japan
    • Mihara Hospital
  • Hokkaido, 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
  • Hyōgo, Japan
    • Hyogo prefecture - Hyogo Mental Health Center
  • Hyōgo, Japan
    • Kobe University Hospital
  • Hyōgo, Japan
    • Medical corporation Shouhokai Toda Internal Medicine and Rehabilitation Department
  • Ishikawa, Japan
    • Awazu Neuropsychiatric Sanatorium
  • Kagoshima, Japan
    • Ishiki Hospital
  • Kagoshima, Japan
    • Minami Kyushu Sakura Hospital
  • Kagoshima, Japan
    • Taniyama Hospital
  • Kanagawa, 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
  • Kumamoto, Japan
    • Yatsushirokosei Hospital
  • Kumamoto, Japan
    • Yuge Hospital
  • Kyoto, Japan
    • Sagaarashiyama Tanaka Clinic
  • Miyagi, Japan
    • Miyagi Psychiatric Center
  • Miyagi, Japan
    • Yasuda Hospital
  • Nagano, Japan
    • National Hospital Organization Komoro kogen Hospital
  • Nagano, Japan
    • North Alps Medical Center Azumi Hospital
  • Nagano, Japan
    • Syonan Hospital
  • Nagasaki, Japan
    • Sanwa Central Hospital
  • Nara, Japan
    • Nara Medical University Hospital
  • Okinawa, Japan
    • Akari Clinic
  • Okinawa, Japan
    • Arakaki Hospital
  • Okinawa, Japan
    • Samariya Hospital
  • Osaka, Japan
    • Keihan Hospital
  • Osaka, Japan
    • Kyowakai Healthcare Corpration Hannan Hospital
  • Saga, Japan
    • Hizen Psychiatric Center
  • Saga, Japan
    • Rainbow & Sea Hospital
  • Saitama, Japan
    • Sho Midori Hospital
  • Shiga, Japan
    • Shiga University of Medical Science Hospital
  • Shimane, Japan
    • Shimane University Hospital
  • Shizuoka, Japan
    • Numazu Chuo Hospital
  • Tokyo, 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
  • Toyama, Japan
    • Kawada Hospital
  • Toyama, Japan
    • Minamitoyama Nakagawa Hospital
  • Yamagata, Japan
    • Public Okitama General Hospital
  • Yamaguchi, Japan
    • National Hospital Organization Kanmon Medical Center
  • Ōita, Japan
    • Hoaki Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.
• Are currently pregnant or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: MT-5199; MT-5199 40 mg capsules; Drug: Placebo; MT-5199 placebo capsules
Experimental: 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.	Drug: MT-5199; MT-5199 40 mg capsules; Drug: Placebo; MT-5199 placebo capsules
Experimental: Placebo (Double-Blind Placebo-Controlled Period); Placebo administered as two (2) placebo capsules, taken by mouth, every morning for 6 weeks.	Drug: Placebo; MT-5199 placebo capsules
Experimental: 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.	Drug: MT-5199; MT-5199 40 mg capsules; Drug: Placebo; MT-5199 placebo capsules
Experimental: 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.	Drug: MT-5199; MT-5199 40 mg capsules; Drug: Placebo; MT-5199 placebo capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Tanabe Pharma Corporation
• Investigators: Study Director: General Manager, Tanabe Pharma Corporation

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2017
• Primary Completion (Actual): September 29, 2020
• Study Completion (Actual): September 29, 2020

Study Registration Dates

• First Submitted: June 2, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Dyskinesias; Dyskinesia, Drug-Induced; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Tardive Dyskinesia
• Other Study ID Numbers: MT-5199-J02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No