Clinical trial NCT03176771: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Tardive Dyskinesia
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2017-06-05
Enrollment: 256
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.
* Are currently pregnant or breastfeeding.

Primary outcomes:
measure: Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Central Assessment) at Week 6
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Percentage of Subjects With a ≥50% Improvement From Baseline in the AIMS Total Score (Central Assessment) at Week 6 (AIMS Responder)
timeFrame: Week 6
measure: Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Site Assessment) at Week 6
timeFrame: Baseline and Week 6
measure: Clinical Global Impression of Change - TD (CGI-TD) Score at Week 6
timeFrame: Week 6
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Aichi Psychiatric Medical Center
city: Aichi
country: Japan
facility: Hotei Hospital
city: Aichi
country: Japan
facility: Mikawa Hospital
city: Aichi
country: Japan
facility: Okehazama Hospital Fujita Kokoro Care Center
city: Akita
country: Japan
facility: Akita City Hospital
city: Akita
country: Japan
facility: Akita University Hospital
city: Aomori
country: Japan
facility: Hirosaki Aiseikai Hospital
city: Aomori
country: Japan
facility: Minato Hospital
city: Aomori
country: Japan
facility: Seinan Hospital
city: Chiba
country: Japan
facility: Kohnodai Hospital , National Center for Global Health and Medicine
city: Chiba
country: Japan
facility: National Hospital Organization Shimofusa Psychiatric Medical Center
city: Ehime
country: Japan
facility: General incorporated association Shinkoukai Shinkouen
city: Fukuoka
country: Japan
facility: Chikusuikai Hospital
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Fukuoka
country: Japan
facility: Hirota Clinic
city: Fukuoka
country: Japan
facility: Iizukakinen Hospital
city: Fukuoka
country: Japan
facility: Kuramitsu Hospital
city: Fukuoka
country: Japan
facility: Minamigaoka Hospital
city: Fukuoka
country: Japan
facility: Yahata Kousei Hospital
city: Fukushima
country: Japan
facility: Nanko Kokorono Clinic
city: Fukushima
country: Japan
facility: Takeda General Hospital
city: Gifu
country: Japan
facility: Holy Cross Hospital
city: Gunma
country: Japan
facility: Seimou Hospital
city: Hiroshima
country: Japan
facility: Hayakawa Clinic
city: Hiroshima
country: Japan
facility: Kamo Psychiatric Center
city: Hiroshima
country: Japan
facility: Medical corporation KOSEIKAI KUSATSU HOSPITAL
city: Hiroshima
country: Japan
facility: Mihara Hospital
city: Hokkaido
country: Japan
facility: Hayashishita Hospital
city: Hokkaido
country: Japan
facility: Ishikane Hospital
city: Hokkaido
country: Japan
facility: National Hospital Organization Hokkaido Medical Center
city: Hokkaido
country: Japan
facility: Obihiro-Kosei General Hospital
city: Hokkaido
country: Japan
facility: Sapporo City General Hospital
city: Hokkaido
country: Japan
facility: Teine Hospital
city: Hyogo
country: Japan
facility: Hyogo prefecture - Hyogo Mental Health Center
city: Hyogo
country: Japan
facility: Kobe University Hospital
city: Hyogo
country: Japan
facility: Medical corporation Shouhokai Toda Internal Medicine and Rehabilitation Department
city: Ishikawa
country: Japan
facility: Awazu Neuropsychiatric Sanatorium
city: Kagoshima
country: Japan
facility: Ishiki Hospital
city: Kagoshima
country: Japan
facility: Minami Kyushu Sakura Hospital
city: Kagoshima
country: Japan
facility: Taniyama Hospital
city: Kanagawa
country: Japan
facility: Fujimidai Hospital
city: Kanagawa
country: Japan
facility: Hatano Kosei Hospital
city: Kanagawa
country: Japan
facility: Hino Hospital
city: Kanagawa
country: Japan
facility: Kishiro Mental Clinic
city: Kanagawa
country: Japan
facility: Kitaodawara Hospital Meihoukai Medical Corporation Association
city: Kanagawa
country: Japan
facility: Shiunkai Yokohama Hospital
city: Kanagawa
country: Japan
facility: Soushu Hospital
city: Kumamoto
country: Japan
facility: Yatsushirokosei Hospital
city: Kumamoto
country: Japan
facility: Yuge Hospital
city: Kyoto
country: Japan
facility: Sagaarashiyama Tanaka Clinic
city: Miyagi
country: Japan
facility: Miyagi Psychiatric Center
city: Miyagi
country: Japan
facility: Yasuda Hospital
city: Nagano
country: Japan
facility: National Hospital Organization Komoro kogen Hospital
city: Nagano
country: Japan
facility: North Alps Medical Center Azumi Hospital
city: Nagano
country: Japan
facility: Syonan Hospital
city: Nagasaki
country: Japan
facility: Sanwa Central Hospital
city: Nara
country: Japan
facility: Nara Medical University Hospital
city: Oita
country: Japan
facility: Hoaki Hospital
city: Okinawa
country: Japan
facility: Akari Clinic
city: Okinawa
country: Japan
facility: Arakaki Hospital
city: Okinawa
country: Japan
facility: Samariya Hospital
city: Osaka
country: Japan
facility: Keihan Hospital
city: Osaka
country: Japan
facility: Kyowakai Healthcare Corpration Hannan Hospital
city: Saga
country: Japan
facility: Hizen Psychiatric Center
city: Saga
country: Japan
facility: Rainbow & Sea Hospital
city: Saitama
country: Japan
facility: Sho Midori Hospital
city: Shiga
country: Japan
facility: Shiga University of Medical Science Hospital
city: Shimane
country: Japan
facility: Shimane University Hospital
city: Shizuoka
country: Japan
facility: Numazu Chuo Hospital
city: Tokyo
country: Japan
facility: Abe Clinic
city: Tokyo
country: Japan
facility: Hozumi Clinic
city: Tokyo
country: Japan
facility: Kyorin University Hospital
city: Tokyo
country: Japan
facility: Maynds Tower Mental Clinic
city: Tokyo
country: Japan
facility: National Center of Neurology and Psychiatry
city: Tokyo
country: Japan
facility: Nishigahara Hospital
city: Tokyo
country: Japan
facility: Ongata Hospital
city: Tokyo
country: Japan
facility: Sangenjaya Neurology-Psychosomatic Clinic
city: Tokyo
country: Japan
facility: Senzoku Mental Clinic
city: Toyama
country: Japan
facility: Kawada Hospital
city: Toyama
country: Japan
facility: Minamitoyama Nakagawa Hospital
city: Yamagata
country: Japan
facility: Public Okitama General Hospital
city: Yamaguchi
country: Japan
facility: National Hospital Organization Kanmon Medical Center
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: General Manager
role: STUDY_DIRECTOR
References:
citation: 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.