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

Tardive Dyskinesia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03176771
• Other study ID #: MT-5199-J02
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 21, 2017
• Est. completion date: September 29, 2020

Study information

• Verified date: August 2023
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: September 29, 2020
• Est. primary completion date: September 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyskinesias
• Tardive Dyskinesia

Intervention

Drug:
• MT-5199
MT-5199 40 mg capsules
• Placebo
MT-5199 placebo capsules

Locations

Country	Name	City	State
Japan	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	Hyogo
Japan	Kobe University Hospital	Hyogo
Japan	Medical corporation Shouhokai Toda Internal Medicine and Rehabilitation Department	Hyogo
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	Hoaki Hospital	Oita
Japan	Akari Clinic	Okinawa
Japan	Arakaki Hospital	Okinawa
Japan	Samariya Hospital	Okinawa
Japan	Keihan Hospital	Osaka
Japan	Kyowakai Healthcare Corpration Hannan Hospital	Osaka
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

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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). Psychiat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and Week 6
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)	Week 6
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.	Baseline and Week 6
Secondary	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