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

Last updated: August 23, 2023
Sponsor: Mitsubishi Tanabe Pharma Corporation
Overall Status: Completed

Phase

2/3

Condition

Tardive Dyskinesia

Dyskinesias

Treatment

MT-5199

Placebo

Clinical Study ID

NCT03176771
MT-5199-J02
  • Ages 20-85
  • All Genders

Study 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

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, orbipolar disorder, or depressive disorders, be on stable doses.

Exclusion

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 Design

Total Participants: 256
Treatment Group(s): 2
Primary Treatment: MT-5199
Phase: 2/3
Study Start date:
June 21, 2017
Estimated Completion Date:
September 29, 2020

Connect with a study center

  • Aichi Psychiatric Medical Center

    Aichi,
    Japan

    Site Not Available

  • Hotei Hospital

    Aichi,
    Japan

    Site Not Available

  • Mikawa Hospital

    Aichi,
    Japan

    Site Not Available

  • Okehazama Hospital Fujita Kokoro Care Center

    Aichi,
    Japan

    Site Not Available

  • Akita City Hospital

    Akita,
    Japan

    Site Not Available

  • Akita University Hospital

    Akita,
    Japan

    Site Not Available

  • Hirosaki Aiseikai Hospital

    Aomori,
    Japan

    Site Not Available

  • Minato Hospital

    Aomori,
    Japan

    Site Not Available

  • Seinan Hospital

    Aomori,
    Japan

    Site Not Available

  • Kohnodai Hospital , National Center for Global Health and Medicine

    Chiba,
    Japan

    Site Not Available

  • National Hospital Organization Shimofusa Psychiatric Medical Center

    Chiba,
    Japan

    Site Not Available

  • General incorporated association Shinkoukai Shinkouen

    Ehime,
    Japan

    Site Not Available

  • Chikusuikai Hospital

    Fukuoka,
    Japan

    Site Not Available

  • Fukuoka University Hospital

    Fukuoka,
    Japan

    Site Not Available

  • Hirota Clinic

    Fukuoka,
    Japan

    Site Not Available

  • Iizukakinen Hospital

    Fukuoka,
    Japan

    Site Not Available

  • Kuramitsu Hospital

    Fukuoka,
    Japan

    Site Not Available

  • Minamigaoka Hospital

    Fukuoka,
    Japan

    Site Not Available

  • Yahata Kousei Hospital

    Fukuoka,
    Japan

    Site Not Available

  • Nanko Kokorono Clinic

    Fukushima,
    Japan

    Site Not Available

  • Takeda General Hospital

    Fukushima,
    Japan

    Site Not Available

  • Holy Cross Hospital

    Gifu,
    Japan

    Site Not Available

  • Seimou Hospital

    Gunma,
    Japan

    Site Not Available

  • Hayakawa Clinic

    Hiroshima,
    Japan

    Site Not Available

  • Kamo Psychiatric Center

    Hiroshima,
    Japan

    Site Not Available

  • Medical corporation KOSEIKAI KUSATSU HOSPITAL

    Hiroshima,
    Japan

    Site Not Available

  • Mihara Hospital

    Hiroshima,
    Japan

    Site Not Available

  • Hayashishita Hospital

    Hokkaido,
    Japan

    Site Not Available

  • Ishikane Hospital

    Hokkaido,
    Japan

    Site Not Available

  • National Hospital Organization Hokkaido Medical Center

    Hokkaido,
    Japan

    Site Not Available

  • Obihiro-Kosei General Hospital

    Hokkaido,
    Japan

    Site Not Available

  • Sapporo City General Hospital

    Hokkaido,
    Japan

    Site Not Available

  • Teine Hospital

    Hokkaido,
    Japan

    Site Not Available

  • Hyogo prefecture - Hyogo Mental Health Center

    Hyogo,
    Japan

    Site Not Available

  • Kobe University Hospital

    Hyogo,
    Japan

    Site Not Available

  • Medical corporation Shouhokai Toda Internal Medicine and Rehabilitation Department

    Hyogo,
    Japan

    Site Not Available

  • Awazu Neuropsychiatric Sanatorium

    Ishikawa,
    Japan

    Site Not Available

  • Ishiki Hospital

    Kagoshima,
    Japan

    Site Not Available

  • Minami Kyushu Sakura Hospital

    Kagoshima,
    Japan

    Site Not Available

  • Taniyama Hospital

    Kagoshima,
    Japan

    Site Not Available

  • Fujimidai Hospital

    Kanagawa,
    Japan

    Site Not Available

  • Hatano Kosei Hospital

    Kanagawa,
    Japan

    Site Not Available

  • Hino Hospital

    Kanagawa,
    Japan

    Site Not Available

  • Kishiro Mental Clinic

    Kanagawa,
    Japan

    Site Not Available

  • Kitaodawara Hospital Meihoukai Medical Corporation Association

    Kanagawa,
    Japan

    Site Not Available

  • Shiunkai Yokohama Hospital

    Kanagawa,
    Japan

    Site Not Available

  • Soushu Hospital

    Kanagawa,
    Japan

    Site Not Available

  • Yatsushirokosei Hospital

    Kumamoto,
    Japan

    Site Not Available

  • Yuge Hospital

    Kumamoto,
    Japan

    Site Not Available

  • Sagaarashiyama Tanaka Clinic

    Kyoto,
    Japan

    Site Not Available

  • Miyagi Psychiatric Center

    Miyagi,
    Japan

    Site Not Available

  • Yasuda Hospital

    Miyagi,
    Japan

    Site Not Available

  • National Hospital Organization Komoro kogen Hospital

    Nagano,
    Japan

    Site Not Available

  • North Alps Medical Center Azumi Hospital

    Nagano,
    Japan

    Site Not Available

  • Syonan Hospital

    Nagano,
    Japan

    Site Not Available

  • Sanwa Central Hospital

    Nagasaki,
    Japan

    Site Not Available

  • Nara Medical University Hospital

    Nara,
    Japan

    Site Not Available

  • Hoaki Hospital

    Oita,
    Japan

    Site Not Available

  • Akari Clinic

    Okinawa,
    Japan

    Site Not Available

  • Arakaki Hospital

    Okinawa,
    Japan

    Site Not Available

  • Samariya Hospital

    Okinawa,
    Japan

    Site Not Available

  • Keihan Hospital

    Osaka,
    Japan

    Site Not Available

  • Kyowakai Healthcare Corpration Hannan Hospital

    Osaka,
    Japan

    Site Not Available

  • Hizen Psychiatric Center

    Saga,
    Japan

    Site Not Available

  • Rainbow & Sea Hospital

    Saga,
    Japan

    Site Not Available

  • Sho Midori Hospital

    Saitama,
    Japan

    Site Not Available

  • Shiga University of Medical Science Hospital

    Shiga,
    Japan

    Site Not Available

  • Shimane University Hospital

    Shimane,
    Japan

    Site Not Available

  • Numazu Chuo Hospital

    Shizuoka,
    Japan

    Site Not Available

  • Abe Clinic

    Tokyo,
    Japan

    Site Not Available

  • Hozumi Clinic

    Tokyo,
    Japan

    Site Not Available

  • Kyorin University Hospital

    Tokyo,
    Japan

    Site Not Available

  • Maynds Tower Mental Clinic

    Tokyo,
    Japan

    Site Not Available

  • National Center of Neurology and Psychiatry

    Tokyo,
    Japan

    Site Not Available

  • Nishigahara Hospital

    Tokyo,
    Japan

    Site Not Available

  • Ongata Hospital

    Tokyo,
    Japan

    Site Not Available

  • Sangenjaya Neurology-Psychosomatic Clinic

    Tokyo,
    Japan

    Site Not Available

  • Senzoku Mental Clinic

    Tokyo,
    Japan

    Site Not Available

  • Kawada Hospital

    Toyama,
    Japan

    Site Not Available

  • Minamitoyama Nakagawa Hospital

    Toyama,
    Japan

    Site Not Available

  • Public Okitama General Hospital

    Yamagata,
    Japan

    Site Not Available

  • National Hospital Organization Kanmon Medical Center

    Yamaguchi,
    Japan

    Site Not Available

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