Trial Outcomes & Findings for Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia (NCT NCT03176771)
NCT ID: NCT03176771
Last Updated: 2026-01-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
256 participants
Primary outcome timeframe
Baseline and Week 6
Results posted on
2026-01-07
Participant Flow
This study enrolled schizophrenia/schizoaffective disorder subject with tardive dyskinesia (TD), or bipolar disorder/depressive disorder with TD from 100 centers in Japan.The last patient completed in September 2020.
Participant milestones
| Measure |
Placebo (Double-Blind Placebo-Controlled Period)
Subjects who were randomized to receive Placebo capsule once daily for 6 weeks.
|
MT-5199 40 mg (Double-Blind Placebo-Controlled Period)
Subjects who were randomized to receive MT-5199 (Valbenazine) 40 mg capsule once daily for 6 weeks.
|
MT-5199 80 mg (Double-Blind Placebo-Controlled Period)
Subjects who were randomized to receive MT-5199 (Valbenazine) 40 mg capsule once daily for 1 weeks, then 80 mg capsule once daily for 5 weeks.
|
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 (Valbenazine) 40 mg or 80 mg and subjects initially randomized to MT-5199 (Valbenazine) will continue with their current dose.
|
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 (Valbenazine) 40 mg or 80 mg and subjects initially randomized to MT-5199 (Valbenazine) will continue with their current dose. Subjects re-randomized to receive MT-5199 (Valbenazine) 80 mg will receive 40 mg for the first week.
|
|---|---|---|---|---|---|
|
Double-Blind Placebo-Controlled Period
STARTED
|
85
|
86
|
85
|
0
|
0
|
|
Double-Blind Placebo-Controlled Period
COMPLETED
|
80
|
71
|
60
|
0
|
0
|
|
Double-Blind Placebo-Controlled Period
NOT COMPLETED
|
5
|
15
|
25
|
0
|
0
|
|
Double-Blind Extension Period
STARTED
|
0
|
0
|
0
|
112
|
99
|
|
Double-Blind Extension Period
COMPLETED
|
0
|
0
|
0
|
67
|
50
|
|
Double-Blind Extension Period
NOT COMPLETED
|
0
|
0
|
0
|
45
|
49
|
Reasons for withdrawal
| Measure |
Placebo (Double-Blind Placebo-Controlled Period)
Subjects who were randomized to receive Placebo capsule once daily for 6 weeks.
|
MT-5199 40 mg (Double-Blind Placebo-Controlled Period)
Subjects who were randomized to receive MT-5199 (Valbenazine) 40 mg capsule once daily for 6 weeks.
|
MT-5199 80 mg (Double-Blind Placebo-Controlled Period)
Subjects who were randomized to receive MT-5199 (Valbenazine) 40 mg capsule once daily for 1 weeks, then 80 mg capsule once daily for 5 weeks.
|
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 (Valbenazine) 40 mg or 80 mg and subjects initially randomized to MT-5199 (Valbenazine) will continue with their current dose.
|
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 (Valbenazine) 40 mg or 80 mg and subjects initially randomized to MT-5199 (Valbenazine) will continue with their current dose. Subjects re-randomized to receive MT-5199 (Valbenazine) 80 mg will receive 40 mg for the first week.
|
|---|---|---|---|---|---|
|
Double-Blind Placebo-Controlled Period
Adverse Event
|
3
|
5
|
14
|
0
|
0
|
|
Double-Blind Placebo-Controlled Period
Physician Decision
|
0
|
2
|
0
|
0
|
0
|
|
Double-Blind Placebo-Controlled Period
Withdrawal by Subject
|
2
|
8
|
10
|
0
|
0
|
|
Double-Blind Placebo-Controlled Period
Incorrect allocation
|
0
|
0
|
1
|
0
|
0
|
|
Double-Blind Extension Period
Adverse Event
|
0
|
0
|
0
|
15
|
18
|
|
Double-Blind Extension Period
Death
|
0
|
0
|
0
|
3
|
4
|
|
Double-Blind Extension Period
Physician Decision
|
0
|
0
|
0
|
3
|
1
|
|
Double-Blind Extension Period
Withdrawal by Subject
|
0
|
0
|
0
|
24
|
26
|
Baseline Characteristics
Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia
Baseline characteristics by cohort
| Measure |
Placebo (Double-Blind Placebo-Controlled Period)
n=84 Participants
Subjects received Placebo capsule (matching MT-5199 capsules) once daily for 6 weeks.
|
MT-5199 40 mg (Double-Blind Placebo-Controlled Period)
n=85 Participants
Subjects received MT-5199 40mg capsule once daily for 6 weeks.
|
MT-5199 80 mg (Double-Blind Placebo-Controlled Period)
n=84 Participants
Subjects received MT-5199 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
|
Total
n=253 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 13.4 • n=37 Participants
|
58.6 years
STANDARD_DEVIATION 14.0 • n=56 Participants
|
58.0 years
STANDARD_DEVIATION 13.8 • n=95 Participants
|
58.9 years
STANDARD_DEVIATION 13.7 • n=61 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=37 Participants
|
45 Participants
n=56 Participants
|
33 Participants
n=95 Participants
|
126 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=37 Participants
|
40 Participants
n=56 Participants
|
51 Participants
n=95 Participants
|
127 Participants
n=61 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=37 Participants
|
85 Participants
n=56 Participants
|
84 Participants
n=95 Participants
|
253 Participants
n=61 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
84 Participants
n=37 Participants
|
85 Participants
n=56 Participants
|
84 Participants
n=95 Participants
|
253 Participants
n=61 Participants
|
|
Race/Ethnicity, Customized
Non-Japanese
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: The analysis population (80 in the placebo, 68 in the MT-5199 40 mg, and 57 in the MT-5199 80 mg) consisted of subjects who satisfy all of the following conditions: * Subjects in the ITT analysis set * Subjects for whom the Week 6 AIMS total score (central assessment) is available
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.
Outcome measures
| Measure |
Placebo (Double-Blind Placebo-Controlled Period)
n=80 Participants
Subjects received Placebo capsule (matching MT-5199 capsules) once daily for 6 weeks.
|
MT-5199 40 mg (Double-Blind Placebo-Controlled Period)
n=68 Participants
Subjects received MT-5199 40mg capsule once daily for 6 weeks.
|
MT-5199 80 mg (Double-Blind Placebo-Controlled Period)
n=57 Participants
Subjects received MT-5199 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
|
|---|---|---|---|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Central Assessment) at Week 6
|
-0.1 units on a scale
Interval -0.8 to 0.5
|
-2.3 units on a scale
Interval -3.0 to -1.7
|
-3.7 units on a scale
Interval -4.4 to -3.0
|
SECONDARY outcome
Timeframe: Week 6Population: The analysis population (78 in the placebo, 67 in the MT-5199 40 mg, and 53 in the MT-5199 80 mg) consisted of subjects who satisfy all of the following conditions: * Subjects in the ITT analysis set * Subjects for whom the Week 6 AIMS total score (central assessment) is available and the baseline AIMS total score (central assessment) is not zero
Percentage of AIMS responders (subjects who had at least a 50 percent reduction in AIMS score from baseline)
Outcome measures
| Measure |
Placebo (Double-Blind Placebo-Controlled Period)
n=78 Participants
Subjects received Placebo capsule (matching MT-5199 capsules) once daily for 6 weeks.
|
MT-5199 40 mg (Double-Blind Placebo-Controlled Period)
n=67 Participants
Subjects received MT-5199 40mg capsule once daily for 6 weeks.
|
MT-5199 80 mg (Double-Blind Placebo-Controlled Period)
n=53 Participants
Subjects received MT-5199 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
|
|---|---|---|---|
|
Percentage of Subjects With a ≥50% Improvement From Baseline in the AIMS Total Score (Central Assessment) at Week 6 (AIMS Responder)
|
10.3 percentage of AIMS responders
|
23.9 percentage of AIMS responders
|
47.2 percentage of AIMS responders
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: The analysis population (80 in the placebo, 68 in the MT-5199 40 mg, and 57 in the MT-5199 80 mg) consisted of subjects who satisfy all of the following conditions: * Subjects in the ITT analysis set * Subjects for whom the Week 6 AIMS total score (site assessment) is available
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.
Outcome measures
| Measure |
Placebo (Double-Blind Placebo-Controlled Period)
n=80 Participants
Subjects received Placebo capsule (matching MT-5199 capsules) once daily for 6 weeks.
|
MT-5199 40 mg (Double-Blind Placebo-Controlled Period)
n=68 Participants
Subjects received MT-5199 40mg capsule once daily for 6 weeks.
|
MT-5199 80 mg (Double-Blind Placebo-Controlled Period)
n=57 Participants
Subjects received MT-5199 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
|
|---|---|---|---|
|
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score (Site Assessment) at Week 6
|
-2.3 units on a scale
Interval -3.2 to -1.5
|
-3.8 units on a scale
Interval -4.7 to -3.0
|
-4.7 units on a scale
Interval -5.6 to -3.8
|
SECONDARY outcome
Timeframe: Week 6Population: The analysis population (80 in the placebo, 70 in the MT-5199 40 mg, and 60 in the MT-5199 80 mg) consisted of subjects who satisfy all of the following conditions: * Subjects in the ITT analysis set * Subjects for whom the Week 6 CGI-TD score is available
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).
Outcome measures
| Measure |
Placebo (Double-Blind Placebo-Controlled Period)
n=80 Participants
Subjects received Placebo capsule (matching MT-5199 capsules) once daily for 6 weeks.
|
MT-5199 40 mg (Double-Blind Placebo-Controlled Period)
n=70 Participants
Subjects received MT-5199 40mg capsule once daily for 6 weeks.
|
MT-5199 80 mg (Double-Blind Placebo-Controlled Period)
n=60 Participants
Subjects received MT-5199 40mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
|
|---|---|---|---|
|
Clinical Global Impression of Change - TD (CGI-TD) Score at Week 6
|
3.4 units on a scale
Interval 3.2 to 3.6
|
3.0 units on a scale
Interval 2.8 to 3.3
|
2.8 units on a scale
Interval 2.5 to 3.0
|
Adverse Events
Placebo (Double-Blind Placebo-Controlled Period)
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
MT-5199 40 mg (Double-Blind Placebo-Controlled Period)
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
MT-5199 80 mg (Double-Blind Placebo-Controlled Period)
Serious events: 1 serious events
Other events: 44 other events
Deaths: 0 deaths
MT-5199 40 mg (Double-Blind Extension Period)
Serious events: 15 serious events
Other events: 71 other events
Deaths: 3 deaths
MT-5199 80 mg (Double-Blind Extension Period)
Serious events: 15 serious events
Other events: 69 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Placebo (Double-Blind Placebo-Controlled Period)
n=84 participants at risk
Subjects received Placebo capsule (matching MT-5199 capsules) once daily for 6 weeks.
|
MT-5199 40 mg (Double-Blind Placebo-Controlled Period)
n=85 participants at risk
Subjects received MT-5199 40 mg capsule once daily for 6 weeks.
|
MT-5199 80 mg (Double-Blind Placebo-Controlled Period)
n=84 participants at risk
Subjects received MT-5199 40 mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
|
MT-5199 40 mg (Double-Blind Extension Period)
n=108 participants at risk
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)
n=95 participants at risk
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.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.93%
1/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
General disorders
Death
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.93%
1/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.1%
1/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
General disorders
Fatigue
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.93%
1/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Infections and infestations
Pneumonia
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.1%
1/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.1%
1/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.1%
1/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.93%
1/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.1%
1/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.2%
1/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.93%
1/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.93%
1/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.93%
1/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.93%
1/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.1%
1/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.2%
1/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.93%
1/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Metabolism and nutrition disorders
Marasmus
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.93%
1/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.93%
1/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.1%
1/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.1%
1/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.93%
1/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Nervous system disorders
Movement disorder
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.1%
1/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Nervous system disorders
Somnolence
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.1%
1/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Nervous system disorders
Stupor
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.1%
1/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Psychiatric disorders
Depression
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
2.1%
2/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.2%
1/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.2%
1/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
4.6%
5/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.1%
1/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.2%
1/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Psychiatric disorders
Suicide attempt
|
1.2%
1/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.93%
1/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.1%
1/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.93%
1/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.1%
1/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.1%
1/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.93%
1/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
Other adverse events
| Measure |
Placebo (Double-Blind Placebo-Controlled Period)
n=84 participants at risk
Subjects received Placebo capsule (matching MT-5199 capsules) once daily for 6 weeks.
|
MT-5199 40 mg (Double-Blind Placebo-Controlled Period)
n=85 participants at risk
Subjects received MT-5199 40 mg capsule once daily for 6 weeks.
|
MT-5199 80 mg (Double-Blind Placebo-Controlled Period)
n=84 participants at risk
Subjects received MT-5199 40 mg capsule once daily for 1 week, then 80mg capsule once daily for 5 weeks.
|
MT-5199 40 mg (Double-Blind Extension Period)
n=108 participants at risk
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)
n=95 participants at risk
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.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
1.2%
1/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
2.4%
2/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.2%
1/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
6.5%
7/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
8.4%
8/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
1.2%
1/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
3.5%
3/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
10.7%
9/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
6.5%
7/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
12.6%
12/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
General disorders
Malaise
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
5.9%
5/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
4.8%
4/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
4.6%
5/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
6.3%
6/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
6/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
7.1%
6/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
4.8%
4/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
25.0%
27/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
21.1%
20/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Injury, poisoning and procedural complications
Contusion
|
1.2%
1/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.2%
1/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
4.6%
5/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
6.3%
6/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.2%
1/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.2%
1/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.93%
1/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
6.3%
6/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Investigations
Weight decreased
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
5.6%
6/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
5.3%
5/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.93%
1/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
5.3%
5/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Nervous system disorders
Akathisia
|
1.2%
1/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
4.7%
4/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
6.0%
5/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
3.7%
4/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
7.4%
7/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Nervous system disorders
Dizziness
|
1.2%
1/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
3.6%
3/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
3.7%
4/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
5.3%
5/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Nervous system disorders
Somnolence
|
2.4%
2/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
11.8%
10/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
25.0%
21/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
8.3%
9/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
8.4%
8/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Nervous system disorders
Tremor
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
6.0%
5/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
4.6%
5/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
11.6%
11/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.2%
1/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
4.8%
4/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
3.7%
4/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
6.3%
6/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Psychiatric disorders
Depression
|
1.2%
1/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.2%
1/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
3.6%
3/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
4.6%
5/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
7.4%
7/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Psychiatric disorders
Insomnia
|
1.2%
1/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
2.4%
2/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
6.0%
5/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
7.4%
8/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
11.6%
11/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Psychiatric disorders
Schizophrenia
|
1.2%
1/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
8.2%
7/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
12.0%
13/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
13.7%
13/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
1.2%
1/85 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
0.00%
0/84 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
5.6%
6/108 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
3.2%
3/95 • Up to Week 6 (Placebo, MT-5199 40 mg, MT-5199 80 mg), and Post Week 6 to Week 48 (MT-5199 40 mg, MT-5199 80 mg)
Subjects who received Placebo or MT-5199 during each period (Double-Blind Placebo-Controlled Period\* and Double-Blind Extension Period\*\*). \* 84 in the placebo, 85 in the MT-5199 40 mg, and 84 in the MT-5199 80 mg \*\* 108 in the MT-5199 40 mg, and 95 in the MT-5199 80 mg
|
Additional Information
Clinical Trials, Information Desk
Tanabe Pharma Corporation
Phone: Please e-mail
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER