Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia
- Conditions
- Tardive Dyskinesia
- Interventions
- Drug: MT-5199Drug: Placebo
- Registration Number
- NCT03176771
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 256
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MT-5199 40 mg (Double-Blind Placebo-Controlled Period) MT-5199 MT-5199 administered as one (1) 40 mg capsule and one (1) placebo capsule, taken by mouth, every morning for 6 weeks. MT-5199 40 mg (Double-Blind Placebo-Controlled Period) Placebo MT-5199 administered as one (1) 40 mg capsule and one (1) placebo capsule, taken by mouth, every morning for 6 weeks. MT-5199 80 mg (Double-Blind Placebo-Controlled Period) MT-5199 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. MT-5199 80 mg (Double-Blind Placebo-Controlled Period) Placebo 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 (Double-Blind Placebo-Controlled Period) Placebo Placebo administered as two (2) placebo capsules, taken by mouth, every morning for 6 weeks. MT-5199 40 mg (Double-Blind Extension Period) MT-5199 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. MT-5199 40 mg (Double-Blind Extension Period) Placebo 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. MT-5199 80 mg (Double-Blind Extension Period) MT-5199 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. MT-5199 80 mg (Double-Blind Extension Period) Placebo 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Central Assessment) at Week 6 Baseline and 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
Name Time Method Percentage of Subjects With a ≥50% Improvement From Baseline in the AIMS Total Score (Central Assessment) at Week 6 (AIMS Responder) Week 6 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 Baseline and 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 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).
Trial Locations
- Locations (82)
Nanko Kokorono Clinic
🇯🇵Fukushima, Japan
Takeda General Hospital
🇯🇵Fukushima, Japan
Holy Cross Hospital
🇯🇵Gifu, Japan
Minamigaoka Hospital
🇯🇵Fukuoka, Japan
Yahata Kousei Hospital
🇯🇵Fukuoka, Japan
Akita City Hospital
🇯🇵Akita, Japan
Minato Hospital
🇯🇵Aomori, Japan
Hotei Hospital
🇯🇵Aichi, Japan
Kohnodai Hospital , National Center for Global Health and Medicine
🇯🇵Chiba, Japan
Aichi Psychiatric Medical Center
🇯🇵Aichi, Japan
Mihara Hospital
🇯🇵Hiroshima, Japan
Fukuoka University Hospital
🇯🇵Fukuoka, Japan
Hirota Clinic
🇯🇵Fukuoka, Japan
Kamo Psychiatric Center
🇯🇵Hiroshima, Japan
Hayakawa Clinic
🇯🇵Hiroshima, Japan
Seimou Hospital
🇯🇵Gunma, Japan
Seinan Hospital
🇯🇵Aomori, Japan
Akita University Hospital
🇯🇵Akita, Japan
Hirosaki Aiseikai Hospital
🇯🇵Aomori, Japan
Chikusuikai Hospital
🇯🇵Fukuoka, Japan
Sapporo City General Hospital
🇯🇵Hokkaido, Japan
Sanwa Central Hospital
🇯🇵Nagasaki, Japan
Kishiro Mental Clinic
🇯🇵Kanagawa, Japan
Public Okitama General Hospital
🇯🇵Yamagata, Japan
Iizukakinen Hospital
🇯🇵Fukuoka, Japan
Kuramitsu Hospital
🇯🇵Fukuoka, Japan
Medical corporation KOSEIKAI KUSATSU HOSPITAL
🇯🇵Hiroshima, Japan
Kobe University Hospital
🇯🇵Hyogo, Japan
Miyagi Psychiatric Center
🇯🇵Miyagi, Japan
Sho Midori Hospital
🇯🇵Saitama, Japan
Samariya Hospital
🇯🇵Okinawa, Japan
Ishikane Hospital
🇯🇵Hokkaido, Japan
Minami Kyushu Sakura Hospital
🇯🇵Kagoshima, Japan
Hino Hospital
🇯🇵Kanagawa, Japan
Mikawa Hospital
🇯🇵Aichi, Japan
Okehazama Hospital Fujita Kokoro Care Center
🇯🇵Aichi, Japan
General incorporated association Shinkoukai Shinkouen
🇯🇵Ehime, Japan
Teine Hospital
🇯🇵Hokkaido, Japan
National Hospital Organization Hokkaido Medical Center
🇯🇵Hokkaido, Japan
Hayashishita Hospital
🇯🇵Hokkaido, Japan
Obihiro-Kosei General Hospital
🇯🇵Hokkaido, Japan
Hyogo prefecture - Hyogo Mental Health Center
🇯🇵Hyogo, Japan
Medical corporation Shouhokai Toda Internal Medicine and Rehabilitation Department
🇯🇵Hyogo, Japan
Awazu Neuropsychiatric Sanatorium
🇯🇵Ishikawa, Japan
Ishiki Hospital
🇯🇵Kagoshima, Japan
Taniyama Hospital
🇯🇵Kagoshima, Japan
Fujimidai Hospital
🇯🇵Kanagawa, Japan
Hatano Kosei Hospital
🇯🇵Kanagawa, Japan
Kitaodawara Hospital Meihoukai Medical Corporation Association
🇯🇵Kanagawa, Japan
Yatsushirokosei Hospital
🇯🇵Kumamoto, Japan
Shiunkai Yokohama Hospital
🇯🇵Kanagawa, Japan
Yuge Hospital
🇯🇵Kumamoto, Japan
Sagaarashiyama Tanaka Clinic
🇯🇵Kyoto, Japan
Soushu Hospital
🇯🇵Kanagawa, Japan
Sangenjaya Neurology-Psychosomatic Clinic
🇯🇵Tokyo, Japan
National Hospital Organization Komoro kogen Hospital
🇯🇵Nagano, Japan
Yasuda Hospital
🇯🇵Miyagi, Japan
North Alps Medical Center Azumi Hospital
🇯🇵Nagano, Japan
Nara Medical University Hospital
🇯🇵Nara, Japan
Hoaki Hospital
🇯🇵Oita, Japan
Akari Clinic
🇯🇵Okinawa, Japan
Arakaki Hospital
🇯🇵Okinawa, Japan
Hizen Psychiatric Center
🇯🇵Saga, Japan
Kyowakai Healthcare Corpration Hannan Hospital
🇯🇵Osaka, Japan
Nishigahara Hospital
🇯🇵Tokyo, Japan
Keihan Hospital
🇯🇵Osaka, Japan
Ongata Hospital
🇯🇵Tokyo, Japan
Shiga University of Medical Science Hospital
🇯🇵Shiga, Japan
Rainbow & Sea Hospital
🇯🇵Saga, Japan
Abe Clinic
🇯🇵Tokyo, Japan
Shimane University Hospital
🇯🇵Shimane, Japan
Hozumi Clinic
🇯🇵Tokyo, Japan
Kyorin University Hospital
🇯🇵Tokyo, Japan
Maynds Tower Mental Clinic
🇯🇵Tokyo, Japan
National Center of Neurology and Psychiatry
🇯🇵Tokyo, Japan
Senzoku Mental Clinic
🇯🇵Tokyo, Japan
National Hospital Organization Kanmon Medical Center
🇯🇵Yamaguchi, Japan
Kawada Hospital
🇯🇵Toyama, Japan
Minamitoyama Nakagawa Hospital
🇯🇵Toyama, Japan
Syonan Hospital
🇯🇵Nagano, Japan
Numazu Chuo Hospital
🇯🇵Shizuoka, Japan
National Hospital Organization Shimofusa Psychiatric Medical Center
🇯🇵Chiba, Japan