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

Primary Purpose

Tardive Dyskinesia

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
MT-5199
Placebo
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tardive Dyskinesia

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

MT-5199 40 mg (Double-Blind Placebo-Controlled Period)

MT-5199 80 mg (Double-Blind Placebo-Controlled Period)

Placebo (Double-Blind Placebo-Controlled Period)

MT-5199 40 mg (Double-Blind Extension Period)

MT-5199 80 mg (Double-Blind Extension Period)

Arm Description

MT-5199 administered as one (1) 40 mg capsule and one (1) placebo capsule, taken by mouth, every morning for 6 weeks.

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.

Placebo administered as two (2) placebo capsules, taken by mouth, every morning for 6 weeks.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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.
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).

Full Information

First Posted
June 2, 2017
Last Updated
August 23, 2023
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03176771
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 21, 2017 (Actual)
Primary Completion Date
September 29, 2020 (Actual)
Study Completion Date
September 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tardive Dyskinesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MT-5199 40 mg (Double-Blind Placebo-Controlled Period)
Arm Type
Experimental
Arm Description
MT-5199 administered as one (1) 40 mg capsule and one (1) placebo capsule, taken by mouth, every morning for 6 weeks.
Arm Title
MT-5199 80 mg (Double-Blind Placebo-Controlled Period)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo (Double-Blind Placebo-Controlled Period)
Arm Type
Experimental
Arm Description
Placebo administered as two (2) placebo capsules, taken by mouth, every morning for 6 weeks.
Arm Title
MT-5199 40 mg (Double-Blind Extension Period)
Arm Type
Experimental
Arm Description
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.
Arm Title
MT-5199 80 mg (Double-Blind Extension Period)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
MT-5199
Intervention Description
MT-5199 40 mg capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
MT-5199 placebo capsules
Primary Outcome Measure Information:
Title
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Central Assessment) at Week 6
Description
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.
Time Frame
Baseline and Week 6
Secondary Outcome Measure Information:
Title
Percentage of Subjects With a ≥50% Improvement From Baseline in the AIMS Total Score (Central Assessment) at Week 6 (AIMS Responder)
Description
Percentage of AIMS responders (subjects who had at least a 50 percent reduction in AIMS score from baseline)
Time Frame
Week 6
Title
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Site Assessment) at Week 6
Description
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.
Time Frame
Baseline and Week 6
Title
Clinical Global Impression of Change - TD (CGI-TD) Score at Week 6
Description
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).
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
General Manager
Organizational Affiliation
Mitsubishi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Aichi Psychiatric Medical Center
City
Aichi
Country
Japan
Facility Name
Hotei Hospital
City
Aichi
Country
Japan
Facility Name
Mikawa Hospital
City
Aichi
Country
Japan
Facility Name
Okehazama Hospital Fujita Kokoro Care Center
City
Aichi
Country
Japan
Facility Name
Akita City Hospital
City
Akita
Country
Japan
Facility Name
Akita University Hospital
City
Akita
Country
Japan
Facility Name
Hirosaki Aiseikai Hospital
City
Aomori
Country
Japan
Facility Name
Minato Hospital
City
Aomori
Country
Japan
Facility Name
Seinan Hospital
City
Aomori
Country
Japan
Facility Name
Kohnodai Hospital , National Center for Global Health and Medicine
City
Chiba
Country
Japan
Facility Name
National Hospital Organization Shimofusa Psychiatric Medical Center
City
Chiba
Country
Japan
Facility Name
General incorporated association Shinkoukai Shinkouen
City
Ehime
Country
Japan
Facility Name
Chikusuikai Hospital
City
Fukuoka
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka
Country
Japan
Facility Name
Hirota Clinic
City
Fukuoka
Country
Japan
Facility Name
Iizukakinen Hospital
City
Fukuoka
Country
Japan
Facility Name
Kuramitsu Hospital
City
Fukuoka
Country
Japan
Facility Name
Minamigaoka Hospital
City
Fukuoka
Country
Japan
Facility Name
Yahata Kousei Hospital
City
Fukuoka
Country
Japan
Facility Name
Nanko Kokorono Clinic
City
Fukushima
Country
Japan
Facility Name
Takeda General Hospital
City
Fukushima
Country
Japan
Facility Name
Holy Cross Hospital
City
Gifu
Country
Japan
Facility Name
Seimou Hospital
City
Gunma
Country
Japan
Facility Name
Hayakawa Clinic
City
Hiroshima
Country
Japan
Facility Name
Kamo Psychiatric Center
City
Hiroshima
Country
Japan
Facility Name
Medical corporation KOSEIKAI KUSATSU HOSPITAL
City
Hiroshima
Country
Japan
Facility Name
Mihara Hospital
City
Hiroshima
Country
Japan
Facility Name
Hayashishita Hospital
City
Hokkaido
Country
Japan
Facility Name
Ishikane Hospital
City
Hokkaido
Country
Japan
Facility Name
National Hospital Organization Hokkaido Medical Center
City
Hokkaido
Country
Japan
Facility Name
Obihiro-Kosei General Hospital
City
Hokkaido
Country
Japan
Facility Name
Sapporo City General Hospital
City
Hokkaido
Country
Japan
Facility Name
Teine Hospital
City
Hokkaido
Country
Japan
Facility Name
Hyogo prefecture - Hyogo Mental Health Center
City
Hyogo
Country
Japan
Facility Name
Kobe University Hospital
City
Hyogo
Country
Japan
Facility Name
Medical corporation Shouhokai Toda Internal Medicine and Rehabilitation Department
City
Hyogo
Country
Japan
Facility Name
Awazu Neuropsychiatric Sanatorium
City
Ishikawa
Country
Japan
Facility Name
Ishiki Hospital
City
Kagoshima
Country
Japan
Facility Name
Minami Kyushu Sakura Hospital
City
Kagoshima
Country
Japan
Facility Name
Taniyama Hospital
City
Kagoshima
Country
Japan
Facility Name
Fujimidai Hospital
City
Kanagawa
Country
Japan
Facility Name
Hatano Kosei Hospital
City
Kanagawa
Country
Japan
Facility Name
Hino Hospital
City
Kanagawa
Country
Japan
Facility Name
Kishiro Mental Clinic
City
Kanagawa
Country
Japan
Facility Name
Kitaodawara Hospital Meihoukai Medical Corporation Association
City
Kanagawa
Country
Japan
Facility Name
Shiunkai Yokohama Hospital
City
Kanagawa
Country
Japan
Facility Name
Soushu Hospital
City
Kanagawa
Country
Japan
Facility Name
Yatsushirokosei Hospital
City
Kumamoto
Country
Japan
Facility Name
Yuge Hospital
City
Kumamoto
Country
Japan
Facility Name
Sagaarashiyama Tanaka Clinic
City
Kyoto
Country
Japan
Facility Name
Miyagi Psychiatric Center
City
Miyagi
Country
Japan
Facility Name
Yasuda Hospital
City
Miyagi
Country
Japan
Facility Name
National Hospital Organization Komoro kogen Hospital
City
Nagano
Country
Japan
Facility Name
North Alps Medical Center Azumi Hospital
City
Nagano
Country
Japan
Facility Name
Syonan Hospital
City
Nagano
Country
Japan
Facility Name
Sanwa Central Hospital
City
Nagasaki
Country
Japan
Facility Name
Nara Medical University Hospital
City
Nara
Country
Japan
Facility Name
Hoaki Hospital
City
Oita
Country
Japan
Facility Name
Akari Clinic
City
Okinawa
Country
Japan
Facility Name
Arakaki Hospital
City
Okinawa
Country
Japan
Facility Name
Samariya Hospital
City
Okinawa
Country
Japan
Facility Name
Keihan Hospital
City
Osaka
Country
Japan
Facility Name
Kyowakai Healthcare Corpration Hannan Hospital
City
Osaka
Country
Japan
Facility Name
Hizen Psychiatric Center
City
Saga
Country
Japan
Facility Name
Rainbow & Sea Hospital
City
Saga
Country
Japan
Facility Name
Sho Midori Hospital
City
Saitama
Country
Japan
Facility Name
Shiga University of Medical Science Hospital
City
Shiga
Country
Japan
Facility Name
Shimane University Hospital
City
Shimane
Country
Japan
Facility Name
Numazu Chuo Hospital
City
Shizuoka
Country
Japan
Facility Name
Abe Clinic
City
Tokyo
Country
Japan
Facility Name
Hozumi Clinic
City
Tokyo
Country
Japan
Facility Name
Kyorin University Hospital
City
Tokyo
Country
Japan
Facility Name
Maynds Tower Mental Clinic
City
Tokyo
Country
Japan
Facility Name
National Center of Neurology and Psychiatry
City
Tokyo
Country
Japan
Facility Name
Nishigahara Hospital
City
Tokyo
Country
Japan
Facility Name
Ongata Hospital
City
Tokyo
Country
Japan
Facility Name
Sangenjaya Neurology-Psychosomatic Clinic
City
Tokyo
Country
Japan
Facility Name
Senzoku Mental Clinic
City
Tokyo
Country
Japan
Facility Name
Kawada Hospital
City
Toyama
Country
Japan
Facility Name
Minamitoyama Nakagawa Hospital
City
Toyama
Country
Japan
Facility Name
Public Okitama General Hospital
City
Yamagata
Country
Japan
Facility Name
National Hospital Organization Kanmon Medical Center
City
Yamaguchi
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
36114799
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.
Results Reference
result

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

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