Trial Outcomes & Findings for Study of SPM 962 in Patients With Restless Legs Syndrome (RLS) (NCT NCT01084551)
NCT ID: NCT01084551
Last Updated: 2014-06-05
Results Overview
Change from the baseline to the end of dose-titration/dose-maintenance period. IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none). The sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
284 participants
Primary outcome timeframe
Baseline, the end of dose-titration/dose-maintenance period (week 13)
Results posted on
2014-06-05
Participant Flow
Participant milestones
| Measure |
Placebo
0 mg/day for 13 weeks
|
SPM 962 4.5
started at 2.25 mg/day to 4.5 mg/day for 13 weeks
|
SPM 962 6.75
started at 2.25 mg/day to 6.75 mg/day for 13 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
95
|
95
|
94
|
|
Overall Study
COMPLETED
|
86
|
81
|
86
|
|
Overall Study
NOT COMPLETED
|
9
|
14
|
8
|
Reasons for withdrawal
| Measure |
Placebo
0 mg/day for 13 weeks
|
SPM 962 4.5
started at 2.25 mg/day to 4.5 mg/day for 13 weeks
|
SPM 962 6.75
started at 2.25 mg/day to 6.75 mg/day for 13 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
9
|
4
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
3
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
Baseline Characteristics
Study of SPM 962 in Patients With Restless Legs Syndrome (RLS)
Baseline characteristics by cohort
| Measure |
Placebo
n=95 Participants
0 mg/day for 13 weeks
|
SPM 962 4.5
n=95 Participants
started at 2.25 mg/day to 4.5 mg/day for 13 weeks
|
SPM 962 6.75
n=94 Participants
started at 2.25 mg/day to 6.75 mg/day for 13 weeks
|
Total
n=284 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 15.3 • n=93 Participants
|
50.7 years
STANDARD_DEVIATION 13.3 • n=4 Participants
|
50.9 years
STANDARD_DEVIATION 13.7 • n=27 Participants
|
51.7 years
STANDARD_DEVIATION 14.1 • n=483 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
65 Participants
n=93 Participants
|
77 Participants
n=4 Participants
|
77 Participants
n=27 Participants
|
219 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
65 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
154 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
130 Participants
n=483 Participants
|
|
Region of Enrollment
Japan
|
95 participants
n=93 Participants
|
95 participants
n=4 Participants
|
94 participants
n=27 Participants
|
284 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline, the end of dose-titration/dose-maintenance period (week 13)Population: Full analysis set (FAS), last observation carried forward (LOCF)
Change from the baseline to the end of dose-titration/dose-maintenance period. IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none). The sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement.
Outcome measures
| Measure |
Placebo
n=95 Participants
Once a daily transdermal administration for 13 weeks
|
SPM 962 4.5
n=93 Participants
Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
|
SPM 962 6.75
n=94 Participants
Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
|
|---|---|---|---|
|
International Restless Legs Syndrome Rating Scale (IRLS) Total Score
|
-11.6 Scores on a scale
Standard Deviation 8.2
|
-14.3 Scores on a scale
Standard Deviation 8.9
|
-14.6 Scores on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Baseline, the end of dose-titration/dose-maintenance period (week 13)Population: FAS, LOCF
CGI improvement is a clinician-reported scale for assessing how much the patient's illness has improved or worsened from baseline. The scale scoring criteria are 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse.
Outcome measures
| Measure |
Placebo
n=95 Participants
Once a daily transdermal administration for 13 weeks
|
SPM 962 4.5
n=93 Participants
Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
|
SPM 962 6.75
n=93 Participants
Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
|
|---|---|---|---|
|
Clinical Global Impression (CGI) Improvement
Subjects with "much improved"
|
24.2 Percentage of Participants
|
25.8 Percentage of Participants
|
29.0 Percentage of Participants
|
|
Clinical Global Impression (CGI) Improvement
Subjects with "very much improved"
|
33.7 Percentage of Participants
|
41.9 Percentage of Participants
|
45.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, the end of dose-titration/dose-maintenance period (week 13)Population: FAS, LOCF
PGI improvement is a patient-reported scale for assessing how much the patient's illness has improved or worsened from baseline. The scale scoring criteria are 1: very much better, 2: much better, 3: a little better, 4: no change, 5: a little worse, 6: much worse, 7: very much worse.
Outcome measures
| Measure |
Placebo
n=95 Participants
Once a daily transdermal administration for 13 weeks
|
SPM 962 4.5
n=93 Participants
Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
|
SPM 962 6.75
n=93 Participants
Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
|
|---|---|---|---|
|
Patient Global Impression (PGI) Improvement
Subjects with "much improved"
|
23.2 Percentage of Participants
|
24.7 Percentage of Participants
|
30.1 Percentage of Participants
|
|
Patient Global Impression (PGI) Improvement
Subjects with "very much improved"
|
38.9 Percentage of Participants
|
48.4 Percentage of Participants
|
50.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, the end of dose-titration/dose-maintenance period (week 13)Population: FAS, LOCF
Change of PSQI from baseline to the end of dose-titration/dose-maintenance period. PSQI is a scale for assessing severity of sleep disorders. The score ranges from 0 to 21. 0 indicates "no difficulty" and 21 indicates "severe difficulty". A decrease in the scores means improvement.
Outcome measures
| Measure |
Placebo
n=94 Participants
Once a daily transdermal administration for 13 weeks
|
SPM 962 4.5
n=93 Participants
Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
|
SPM 962 6.75
n=90 Participants
Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
|
|---|---|---|---|
|
The Pittsburgh Sleep Quality Index (PSQI)
|
-2.5 Scores on a scale
Standard Deviation 2.4
|
-3.1 Scores on a scale
Standard Deviation 3.2
|
-3.2 Scores on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Baseline, the end of dose-titration/dose-maintenance period (week 13)Population: FAS, LOCF
IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none). Numbers of subjects with -4 or -3 score change from baseline in each item of IRLS. A decrease in the scores means improvement.
Outcome measures
| Measure |
Placebo
n=95 Participants
Once a daily transdermal administration for 13 weeks
|
SPM 962 4.5
n=93 Participants
Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
|
SPM 962 6.75
n=94 Participants
Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
|
|---|---|---|---|
|
Each Item of IRLS (10 Items)
-3 (RLS symptoms frequency)
|
12.6 percentage of participants
|
9.7 percentage of participants
|
11.7 percentage of participants
|
|
Each Item of IRLS (10 Items)
-4 (RLS discomfort)
|
1.1 percentage of participants
|
2.2 percentage of participants
|
6.4 percentage of participants
|
|
Each Item of IRLS (10 Items)
-3 (RLS discomfort)
|
11.6 percentage of participants
|
17.2 percentage of participants
|
12.8 percentage of participants
|
|
Each Item of IRLS (10 Items)
-4 (need to move around due to RLS symptoms)
|
2.1 percentage of participants
|
2.2 percentage of participants
|
7.4 percentage of participants
|
|
Each Item of IRLS (10 Items)
-3 (need to move around due to RLS symptoms)
|
11.6 percentage of participants
|
25.8 percentage of participants
|
18.1 percentage of participants
|
|
Each Item of IRLS (10 Items)
-4 (discomfort relief by moving around)
|
0 percentage of participants
|
1.1 percentage of participants
|
2.1 percentage of participants
|
|
Each Item of IRLS (10 Items)
-3 (discomfort relief by moving around)
|
10.5 percentage of participants
|
20.4 percentage of participants
|
28.7 percentage of participants
|
|
Each Item of IRLS (10 Items)
-4 (severity of RLS as a whole)
|
1.1 percentage of participants
|
1.1 percentage of participants
|
4.3 percentage of participants
|
|
Each Item of IRLS (10 Items)
-3 (severity of RLS as a whole)
|
6.3 percentage of participants
|
12.9 percentage of participants
|
12.8 percentage of participants
|
|
Each Item of IRLS (10 Items)
-4 (RLS symptoms frequency)
|
12.6 percentage of participants
|
24.7 percentage of participants
|
26.6 percentage of participants
|
|
Each Item of IRLS (10 Items)
-4 (average duration of RLS symptoms)
|
1.1 percentage of participants
|
2.2 percentage of participants
|
2.1 percentage of participants
|
|
Each Item of IRLS (10 Items)
-3 (average duration of RLS symptoms)
|
6.3 percentage of participants
|
10.8 percentage of participants
|
9.6 percentage of participants
|
|
Each Item of IRLS (10 Items)
-4 (severity of sleep disturbance)
|
2.1 percentage of participants
|
4.3 percentage of participants
|
6.4 percentage of participants
|
|
Each Item of IRLS (10 Items)
-3 (severity of sleep disturbance)
|
16.8 percentage of participants
|
16.1 percentage of participants
|
21.3 percentage of participants
|
|
Each Item of IRLS (10 Items)
-4 (tiredness or sleepiness during the day)
|
0 percentage of participants
|
2.2 percentage of participants
|
2.1 percentage of participants
|
|
Each Item of IRLS (10 Items)
-3 (tiredness or sleepiness during the day)
|
8.4 percentage of participants
|
11.8 percentage of participants
|
8.5 percentage of participants
|
|
Each Item of IRLS (10 Items)
-4 (severity of the impact on daily affairs)
|
0 percentage of participants
|
1.1 percentage of participants
|
1.1 percentage of participants
|
|
Each Item of IRLS (10 Items)
-3 (severity of the impact on daily affairs)
|
8.4 percentage of participants
|
11.8 percentage of participants
|
4.3 percentage of participants
|
|
Each Item of IRLS (10 Items)
-4 (severity of mood disturbance)
|
1.1 percentage of participants
|
4.3 percentage of participants
|
1.1 percentage of participants
|
|
Each Item of IRLS (10 Items)
-3 (severity of mood disturbance)
|
8.4 percentage of participants
|
10.8 percentage of participants
|
12.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, the end of dose-titration/dose-maintenance period (week 13)Population: FAS, LOCF
Incidence rate of RLS symptoms is calculated as the number of days with RLS symptoms in the week / the number of evaluation days in the week\* 100%
Outcome measures
| Measure |
Placebo
n=95 Participants
Once a daily transdermal administration for 13 weeks
|
SPM 962 4.5
n=93 Participants
Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
|
SPM 962 6.75
n=92 Participants
Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
|
|---|---|---|---|
|
Incidence of RLS Symptoms
Baseline
|
85.7 percentage of days with RLS symptom
Standard Deviation 20.8
|
85.4 percentage of days with RLS symptom
Standard Deviation 20.5
|
83.2 percentage of days with RLS symptom
Standard Deviation 22.2
|
|
Incidence of RLS Symptoms
Week 13
|
48.7 percentage of days with RLS symptom
Standard Deviation 40.9
|
35.8 percentage of days with RLS symptom
Standard Deviation 38.6
|
36.8 percentage of days with RLS symptom
Standard Deviation 38.8
|
SECONDARY outcome
Timeframe: Baseline, the end of dose-titration/dose-maintenance period (weeks 13)Population: FAS, LOCF
Change of average duration of RLS symptoms in a week from baseline to the end of dose-titration/dose-maintenance period. Only the days with RLS symptoms are used for calculation.
Outcome measures
| Measure |
Placebo
n=71 Participants
Once a daily transdermal administration for 13 weeks
|
SPM 962 4.5
n=59 Participants
Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
|
SPM 962 6.75
n=55 Participants
Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
|
|---|---|---|---|
|
Average Duration of RLS Symptoms
|
-3.1 Hours
Standard Deviation 4.7
|
-3.7 Hours
Standard Deviation 4.6
|
-4.3 Hours
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Baseline, the end of dose-titration/dose-maintenance period (week 13)Population: FAS, LOCF
Incidence rate of RLS symptoms is calculated as the number of days with RLS symptoms / the number of days of evaluation \* 100%.
Outcome measures
| Measure |
Placebo
n=95 Participants
Once a daily transdermal administration for 13 weeks
|
SPM 962 4.5
n=93 Participants
Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
|
SPM 962 6.75
n=92 Participants
Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
|
|---|---|---|---|
|
Incidence of RLS Symptoms in the Evening and Night
Baseline
|
80.6 percentage of days/week with symptoms
Standard Deviation 24.2
|
83.3 percentage of days/week with symptoms
Standard Deviation 20.8
|
79.5 percentage of days/week with symptoms
Standard Deviation 24.2
|
|
Incidence of RLS Symptoms in the Evening and Night
Week 13
|
45.4 percentage of days/week with symptoms
Standard Deviation 41.0
|
34.6 percentage of days/week with symptoms
Standard Deviation 38.2
|
31.8 percentage of days/week with symptoms
Standard Deviation 37.7
|
SECONDARY outcome
Timeframe: Baseline, the end of dose-titration/dose-maintenance period (weeks 13)Population: FAS, LOCF
Change of average duration of RLS symptoms in a week from baseline to the end of dose-titration/dose-maintenance period. Only the days with RLS symptoms are used for calculation.
Outcome measures
| Measure |
Placebo
n=69 Participants
Once a daily transdermal administration for 13 weeks
|
SPM 962 4.5
n=58 Participants
Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
|
SPM 962 6.75
n=50 Participants
Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
|
|---|---|---|---|
|
Average Duration of RLS Symptoms in the Evening and Night in a Week
|
-1.3 Hours
Standard Deviation 3.1
|
-1.8 Hours
Standard Deviation 2.5
|
-1.5 Hours
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Baseline, the end of dose-titration/dose-maintenance period (week 13)Population: FAS, LOCF
Nocturnal awakening rate is calculated as the number of days with nocturnal awakenings / the number of days of evaluation \* 100%.
Outcome measures
| Measure |
Placebo
n=95 Participants
Once a daily transdermal administration for 13 weeks
|
SPM 962 4.5
n=93 Participants
Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
|
SPM 962 6.75
n=92 Participants
Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
|
|---|---|---|---|
|
Nocturnal Awakenings Due to RLS Symptoms in a Week
Baseline
|
33.5 percentage of days/week with awakening
Standard Deviation 35.9
|
22.6 percentage of days/week with awakening
Standard Deviation 31.3
|
28.3 percentage of days/week with awakening
Standard Deviation 34.3
|
|
Nocturnal Awakenings Due to RLS Symptoms in a Week
Week 13
|
15.6 percentage of days/week with awakening
Standard Deviation 31.7
|
7.7 percentage of days/week with awakening
Standard Deviation 20.5
|
7.5 percentage of days/week with awakening
Standard Deviation 19.5
|
SECONDARY outcome
Timeframe: Baseline, the end of dose-titration/dose-maintenance period (weeks 13)Population: FAS, LOCF
Change of average sleep time in a week from baseline to the end of dose-titration/dose-maintenance period.
Outcome measures
| Measure |
Placebo
n=95 Participants
Once a daily transdermal administration for 13 weeks
|
SPM 962 4.5
n=93 Participants
Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
|
SPM 962 6.75
n=92 Participants
Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
|
|---|---|---|---|
|
Average Sleep Time in a Week
|
0.4 Hours
Standard Deviation 0.8
|
0.5 Hours
Standard Deviation 1.1
|
0.4 Hours
Standard Deviation 1.1
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
SPM 962 4.5
Serious events: 0 serious events
Other events: 72 other events
Deaths: 0 deaths
SPM 962 6.75
Serious events: 1 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=95 participants at risk
0 mg/day for 13 weeks
|
SPM 962 4.5
n=95 participants at risk
started at 2.25 mg/day to 4.5 mg/day for 13 weeks
|
SPM 962 6.75
n=94 participants at risk
started at 2.25 mg/day to 6.75 mg/day for 13 weeks
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/95 • 14 weeks
|
0.00%
0/95 • 14 weeks
|
1.1%
1/94 • Number of events 1 • 14 weeks
|
|
Injury, poisoning and procedural complications
Traffic Accident
|
0.00%
0/95 • 14 weeks
|
0.00%
0/95 • 14 weeks
|
1.1%
1/94 • Number of events 1 • 14 weeks
|
|
Nervous system disorders
Lacunar Infarction
|
1.1%
1/95 • Number of events 1 • 14 weeks
|
0.00%
0/95 • 14 weeks
|
0.00%
0/94 • 14 weeks
|
|
Nervous system disorders
VIIth Nerve Paralysis
|
1.1%
1/95 • Number of events 1 • 14 weeks
|
0.00%
0/95 • 14 weeks
|
0.00%
0/94 • 14 weeks
|
Other adverse events
| Measure |
Placebo
n=95 participants at risk
0 mg/day for 13 weeks
|
SPM 962 4.5
n=95 participants at risk
started at 2.25 mg/day to 4.5 mg/day for 13 weeks
|
SPM 962 6.75
n=94 participants at risk
started at 2.25 mg/day to 6.75 mg/day for 13 weeks
|
|---|---|---|---|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/95 • 14 weeks
|
0.00%
0/95 • 14 weeks
|
3.2%
3/94 • Number of events 3 • 14 weeks
|
|
Gastrointestinal disorders
Nausea
|
9.5%
9/95 • Number of events 12 • 14 weeks
|
33.7%
32/95 • Number of events 37 • 14 weeks
|
43.6%
41/94 • Number of events 48 • 14 weeks
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/95 • Number of events 2 • 14 weeks
|
4.2%
4/95 • Number of events 5 • 14 weeks
|
10.6%
10/94 • Number of events 11 • 14 weeks
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
3.2%
3/95 • Number of events 3 • 14 weeks
|
0.00%
0/95 • 14 weeks
|
10.6%
10/94 • Number of events 11 • 14 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/95 • 14 weeks
|
3.2%
3/95 • Number of events 3 • 14 weeks
|
1.1%
1/94 • Number of events 1 • 14 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/95 • 14 weeks
|
3.2%
3/95 • Number of events 3 • 14 weeks
|
3.2%
3/94 • Number of events 3 • 14 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
3/95 • Number of events 3 • 14 weeks
|
0.00%
0/95 • 14 weeks
|
1.1%
1/94 • Number of events 1 • 14 weeks
|
|
General disorders
Application Site Reaction
|
7.4%
7/95 • Number of events 8 • 14 weeks
|
42.1%
40/95 • Number of events 41 • 14 weeks
|
50.0%
47/94 • Number of events 50 • 14 weeks
|
|
General disorders
Malaise
|
1.1%
1/95 • Number of events 2 • 14 weeks
|
2.1%
2/95 • Number of events 2 • 14 weeks
|
3.2%
3/94 • Number of events 3 • 14 weeks
|
|
Infections and infestations
Nasopharyngitis
|
12.6%
12/95 • Number of events 17 • 14 weeks
|
12.6%
12/95 • Number of events 14 • 14 weeks
|
17.0%
16/94 • Number of events 17 • 14 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/95 • 14 weeks
|
5.3%
5/95 • Number of events 6 • 14 weeks
|
2.1%
2/94 • Number of events 2 • 14 weeks
|
|
Nervous system disorders
Dizziness
|
3.2%
3/95 • Number of events 3 • 14 weeks
|
2.1%
2/95 • Number of events 2 • 14 weeks
|
1.1%
1/94 • Number of events 1 • 14 weeks
|
|
Psychiatric disorders
Somnolence
|
2.1%
2/95 • Number of events 2 • 14 weeks
|
10.5%
10/95 • Number of events 10 • 14 weeks
|
14.9%
14/94 • Number of events 14 • 14 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
1.1%
1/95 • Number of events 1 • 14 weeks
|
3.2%
3/95 • Number of events 4 • 14 weeks
|
4.3%
4/94 • Number of events 4 • 14 weeks
|
Additional Information
Director of Clinical Research and Development
Otsuka Pharmaceutical Co., Ltd.
Phone: +81-3-6361-7366
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place