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

Sponsor

Mitsubishi Tanabe Pharma Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT03176771

Collaborator

(none)

256

Enrollment

Locations

Arms

39.3

Actual Duration (Months)

3.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tardive Dyskinesia	Drug: MT-5199 Drug: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

256 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Jun 21, 2017

Actual Primary Completion Date :

Sep 29, 2020

Actual Study Completion Date :

Sep 29, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Severity of tardive dyskinesia (TD) symptoms assessed by Abnormal Involuntary Movements Scale (AIMS), change from baseline [Baseline, Week 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country
1	Aichi Psychiatric Medical Center	Aichi	Japan
2	Hotei Hospital	Aichi	Japan
3	Mikawa Hospital	Aichi	Japan
4	Okehazama Hospital Fujita Kokoro Care Center	Aichi	Japan
5	Akita City Hospital	Akita	Japan
6	Akita University Hospital	Akita	Japan
7	Hirosaki Aiseikai Hospital	Aomori	Japan
8	Minato Hospital	Aomori	Japan
9	Seinan Hospital	Aomori	Japan
10	Kohnodai Hospital , National Center for Global Health and Medicine	Chiba	Japan
11	National Hospital Organization Shimofusa Psychiatric Medical Center	Chiba	Japan
12	General incorporated association Shinkoukai Shinkouen	Ehime	Japan
13	Chikusuikai Hospital	Fukuoka	Japan
14	Fukuoka University Hospital	Fukuoka	Japan
15	Hirota Clinic	Fukuoka	Japan
16	Iizukakinen Hospital	Fukuoka	Japan
17	Kuramitsu Hospital	Fukuoka	Japan
18	Minamigaoka Hospital	Fukuoka	Japan
19	Yahata Kousei Hospital	Fukuoka	Japan
20	Nanko Kokorono Clinic	Fukushima	Japan
21	Takeda General Hospital	Fukushima	Japan
22	Holy Cross Hospital	Gifu	Japan
23	Seimou Hospital	Gunma	Japan
24	Hayakawa Clinic	Hiroshima	Japan
25	Kamo Psychiatric Center	Hiroshima	Japan
26	Medical corporation KOSEIKAI KUSATSU HOSPITAL	Hiroshima	Japan
27	Mihara Hospital	Hiroshima	Japan
28	Hayashishita Hospital	Hokkaido	Japan
29	Ishikane Hospital	Hokkaido	Japan
30	National Hospital Organization Hokkaido Medical Center	Hokkaido	Japan
31	Obihiro-Kosei General Hospital	Hokkaido	Japan
32	Sapporo City General Hospital	Hokkaido	Japan
33	Teine Hospital	Hokkaido	Japan
34	Hyogo prefecture - Hyogo Mental Health Center	Hyogo	Japan
35	Kobe University Hospital	Hyogo	Japan
36	Medical corporation Shouhokai Toda Internal Medicine and Rehabilitation Department	Hyogo	Japan
37	Awazu Neuropsychiatric Sanatorium	Ishikawa	Japan
38	Ishiki Hospital	Kagoshima	Japan
39	Minami Kyushu Sakura Hospital	Kagoshima	Japan
40	Taniyama Hospital	Kagoshima	Japan
41	Fujimidai Hospital	Kanagawa	Japan
42	Hatano Kosei Hospital	Kanagawa	Japan
43	Hino Hospital	Kanagawa	Japan
44	Kishiro Mental Clinic	Kanagawa	Japan
45	Kitaodawara Hospital Meihoukai Medical Corporation Association	Kanagawa	Japan
46	Shiunkai Yokohama Hospital	Kanagawa	Japan
47	Soushu Hospital	Kanagawa	Japan
48	Yatsushirokosei Hospital	Kumamoto	Japan
49	Yuge Hospital	Kumamoto	Japan
50	Sagaarashiyama Tanaka Clinic	Kyoto	Japan
51	Miyagi Psychiatric Center	Miyagi	Japan
52	Yasuda Hospital	Miyagi	Japan
53	National Hospital Organization Komoro kogen Hospital	Nagano	Japan
54	North Alps Medical Center Azumi Hospital	Nagano	Japan
55	Syonan Hospital	Nagano	Japan
56	Sanwa Central Hospital	Nagasaki	Japan
57	Nara Medical University Hospital	Nara	Japan
58	Hoaki Hospital	Oita	Japan
59	Akari Clinic	Okinawa	Japan
60	Arakaki Hospital	Okinawa	Japan
61	Samariya Hospital	Okinawa	Japan
62	Keihan Hospital	Osaka	Japan
63	Kyowakai Healthcare Corpration Hannan Hospital	Osaka	Japan
64	Hizen Psychiatric Center	Saga	Japan
65	Rainbow & Sea Hospital	Saga	Japan
66	Sho Midori Hospital	Saitama	Japan
67	Shiga University of Medical Science Hospital	Shiga	Japan
68	Shimane University Hospital	Shimane	Japan
69	Numazu Chuo Hospital	Shizuoka	Japan
70	Abe Clinic	Tokyo	Japan
71	Hozumi Clinic	Tokyo	Japan
72	Kyorin University Hospital	Tokyo	Japan
73	Maynds Tower Mental Clinic	Tokyo	Japan
74	National Center of Neurology and Psychiatry	Tokyo	Japan
75	Nishigahara Hospital	Tokyo	Japan
76	Ongata Hospital	Tokyo	Japan
77	Sangenjaya Neurology-Psychosomatic Clinic	Tokyo	Japan
78	Senzoku Mental Clinic	Tokyo	Japan
79	Kawada Hospital	Toyama	Japan
80	Minamitoyama Nakagawa Hospital	Toyama	Japan
81	Public Okitama General Hospital	Yamagata	Japan
82	National Hospital Organization Kanmon Medical Center	Yamaguchi	Japan

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation

Investigators

Study Director: General Manager, Mitsubishi Tanabe Pharma Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mitsubishi Tanabe Pharma Corporation

ClinicalTrials.gov Identifier:

NCT03176771

Other Study ID Numbers:

MT-5199-J02

First Posted:

Jun 5, 2017

Last Update Posted:

Oct 9, 2020

Last Verified:

Jul 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dyskinesias

Tardive Dyskinesia

Study Results

No Results Posted as of Oct 9, 2020