Trial Outcomes & Findings for A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients (NCT NCT00666965)
NCT ID: NCT00666965
Last Updated: 2014-04-25
Results Overview
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
PHASE2
Target enrollment
230 participants
Primary outcome timeframe
Baseline, end of maintenance period at 6 weeks
Results posted on
2014-04-25
Participant Flow
Participant milestones
| Measure |
Placebo
placebo transdermal patch
|
2.25 mg/Day
SPM962 maintein dose: 2.25 mg/day
|
4.5 mg/Day
SPM962 maintein dose: 4.5mg/day
|
6.75 mg/Day
SPM962 maintein dose: 6.75 mg/day
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
58
|
57
|
58
|
57
|
|
Overall Study
COMPLETED
|
55
|
53
|
56
|
42
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
2
|
15
|
Reasons for withdrawal
| Measure |
Placebo
placebo transdermal patch
|
2.25 mg/Day
SPM962 maintein dose: 2.25 mg/day
|
4.5 mg/Day
SPM962 maintein dose: 4.5mg/day
|
6.75 mg/Day
SPM962 maintein dose: 6.75 mg/day
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
1
|
9
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
2
|
|
Overall Study
Discontinuation criteria
|
2
|
1
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
Baseline Characteristics
A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients
Baseline characteristics by cohort
| Measure |
Placebo
n=57 Participants
placebo transdermal patch
|
2.25 mg/Day
n=57 Participants
SPM962 maintein dose: 2.25 mg/day
|
4.5 mg/Day
n=57 Participants
SPM962 maintein dose: 4.5mg/day
|
6.75 mg/Day
n=56 Participants
SPM962 maintein dose: 6.75 mg/day
|
Total
n=227 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
193 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
50.6 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
48.3 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
51.0 years
STANDARD_DEVIATION 12.4 • n=4 Participants
|
49.6 years
STANDARD_DEVIATION 13.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
143 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
57 participants
n=5 Participants
|
57 participants
n=7 Participants
|
57 participants
n=5 Participants
|
56 participants
n=4 Participants
|
227 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, end of maintenance period at 6 weeksPopulation: Full analysis set (FAS), last observation carried forward (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). 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=57 Participants
placebo transdermal patch
|
2.25 mg/Day
n=55 Participants
SPM962 maintein dose: 2.25 mg/day
|
4.5 mg/Day
n=56 Participants
SPM962 maintein dose: 4.5mg/day
|
6.75 mg/Day
n=51 Participants
SPM962 maintein dose: 6.75 mg/day
|
|---|---|---|---|---|
|
Change of International Restless Legs Syndrome Study Group Rating Scale (IRLS) Score From the Baseline to the End of Titration/Maintenance Period
|
-9.8 scores on a scale
Standard Deviation 7.2
|
-10.7 scores on a scale
Standard Deviation 6.3
|
-14.4 scores on a scale
Standard Deviation 7.2
|
-14.1 scores on a scale
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.Population: FAS, LOCF
CGI is a clinician-reported scale for assessing severity of illness. The sale scoring criteria are 1: Normal, not at all ill, 2: Borderline ill, 3: Mildly ill, 4: Moderately ill, 5: Markedly ill, 6: Severely ill, 7: Among the most extremely ill patients.
Outcome measures
| Measure |
Placebo
n=57 Participants
placebo transdermal patch
|
2.25 mg/Day
n=55 Participants
SPM962 maintein dose: 2.25 mg/day
|
4.5 mg/Day
n=56 Participants
SPM962 maintein dose: 4.5mg/day
|
6.75 mg/Day
n=51 Participants
SPM962 maintein dose: 6.75 mg/day
|
|---|---|---|---|---|
|
Clinical Global Impression (CGI) Severity
Decreased
|
73.7 Percentage of Participants
|
83.6 Percentage of Participants
|
92.9 Percentage of Participants
|
86.3 Percentage of Participants
|
|
Clinical Global Impression (CGI) Severity
Increased
|
1.8 Percentage of Participants
|
1.8 Percentage of Participants
|
0.0 Percentage of Participants
|
3.9 Percentage of Participants
|
|
Clinical Global Impression (CGI) Severity
Decreased to 1 or 2
|
12.3 Percentage of Participants
|
18.2 Percentage of Participants
|
41.1 Percentage of Participants
|
39.2 Percentage of Participants
|
|
Clinical Global Impression (CGI) Severity
Subjects with CGI score 5
|
8.8 Percentage of Participants
|
12.7 Percentage of Participants
|
3.6 Percentage of Participants
|
7.8 Percentage of Participants
|
|
Clinical Global Impression (CGI) Severity
Subjects without improvement
|
26.3 Percentage of Participants
|
16.4 Percentage of Participants
|
7.1 Percentage of Participants
|
13.7 Percentage of Participants
|
|
Clinical Global Impression (CGI) Severity
4 at baseline and stayed at 4
|
26.5 Percentage of Participants
|
13.3 Percentage of Participants
|
10.7 Percentage of Participants
|
10.7 Percentage of Participants
|
|
Clinical Global Impression (CGI) Severity
5 at baseline and decreased to 1 or 2
|
0 Percentage of Participants
|
24.0 Percentage of Participants
|
46.4 Percentage of Participants
|
30.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks and 6 weeks. The data at 6 weeks after dosing is shown.Population: FAS, LOCF
The PGI-I is a self-rated 7-point scale, with scores ranging from 1 (very much improved) to 7 (very much worse), that assesses the improvement or worsening of a patient's illness relative to baseline at the beginning of the intervention. Scores: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse. Moderate and marked improvement = score of 1 or 2, Without improvement = score of 4, Marked and moderate aggravation = score of 6 or 7.
Outcome measures
| Measure |
Placebo
n=56 Participants
placebo transdermal patch
|
2.25 mg/Day
n=54 Participants
SPM962 maintein dose: 2.25 mg/day
|
4.5 mg/Day
n=56 Participants
SPM962 maintein dose: 4.5mg/day
|
6.75 mg/Day
n=48 Participants
SPM962 maintein dose: 6.75 mg/day
|
|---|---|---|---|---|
|
Patient Global Impression (PGI) Improvement
Moderate and marked improvement
|
55.4 Percentage of Participants
|
70.4 Percentage of Participants
|
82.1 Percentage of Participants
|
85.4 Percentage of Participants
|
|
Patient Global Impression (PGI) Improvement
Without improvement
|
17.9 Percentage of Participants
|
3.7 Percentage of Participants
|
3.6 Percentage of Participants
|
6.3 Percentage of Participants
|
|
Patient Global Impression (PGI) Improvement
Moderate and marked aggravation
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
1.8 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, every two weeksPopulation: FAS, LOCF
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. The data at 6 weeks after dosing is shown.
Outcome measures
| Measure |
Placebo
n=56 Participants
placebo transdermal patch
|
2.25 mg/Day
n=54 Participants
SPM962 maintein dose: 2.25 mg/day
|
4.5 mg/Day
n=56 Participants
SPM962 maintein dose: 4.5mg/day
|
6.75 mg/Day
n=47 Participants
SPM962 maintein dose: 6.75 mg/day
|
|---|---|---|---|---|
|
The Pittsburgh Sleep Quality Index (PSQI)
Subjects with ≥60% decrease
|
7.1 Percentage of Participants
|
16.7 Percentage of Participants
|
23.2 Percentage of Participants
|
23.4 Percentage of Participants
|
|
The Pittsburgh Sleep Quality Index (PSQI)
Subjects with ≥50% decrease
|
25.0 Percentage of Participants
|
27.8 Percentage of Participants
|
39.3 Percentage of Participants
|
44.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, every two weeksPopulation: FAS, LOCF
Mean Change from baseline in MOS Short Form SF-36 to 6 weeks after dosing. SF-36 is a scale for assessing health status in clinical practice and research. The scores of 36 questions are summarized into 7 sub-scales. In each sub-scale which range is 0-100, a higher score indicates a better health status. Thus a increase in the scores means improvement.
Outcome measures
| Measure |
Placebo
n=56 Participants
placebo transdermal patch
|
2.25 mg/Day
n=54 Participants
SPM962 maintein dose: 2.25 mg/day
|
4.5 mg/Day
n=56 Participants
SPM962 maintein dose: 4.5mg/day
|
6.75 mg/Day
n=47 Participants
SPM962 maintein dose: 6.75 mg/day
|
|---|---|---|---|---|
|
Medical Outcome Study (MOS) Short-Form 36-Item Health Survey (SF-36)
Physical functioning
|
1.1 Scores on a scale
Standard Deviation 8.1
|
1.6 Scores on a scale
Standard Deviation 9.6
|
2.8 Scores on a scale
Standard Deviation 12.7
|
0.1 Scores on a scale
Standard Deviation 6.1
|
|
Medical Outcome Study (MOS) Short-Form 36-Item Health Survey (SF-36)
Role physical
|
-0.4 Scores on a scale
Standard Deviation 18.0
|
1.7 Scores on a scale
Standard Deviation 18.7
|
1.3 Scores on a scale
Standard Deviation 15.8
|
0.9 Scores on a scale
Standard Deviation 11.9
|
|
Medical Outcome Study (MOS) Short-Form 36-Item Health Survey (SF-36)
Bodily pain
|
-1.7 Scores on a scale
Standard Deviation 25.0
|
5.0 Scores on a scale
Standard Deviation 28.0
|
1.7 Scores on a scale
Standard Deviation 27.4
|
12.6 Scores on a scale
Standard Deviation 19.7
|
|
Medical Outcome Study (MOS) Short-Form 36-Item Health Survey (SF-36)
General health
|
3.4 Scores on a scale
Standard Deviation 16.4
|
2.5 Scores on a scale
Standard Deviation 10.5
|
4.6 Scores on a scale
Standard Deviation 14.8
|
4.9 Scores on a scale
Standard Deviation 12.9
|
|
Medical Outcome Study (MOS) Short-Form 36-Item Health Survey (SF-36)
Vitality
|
6.3 Scores on a scale
Standard Deviation 16.6
|
6.5 Scores on a scale
Standard Deviation 17.2
|
3.6 Scores on a scale
Standard Deviation 19.9
|
6.5 Scores on a scale
Standard Deviation 18.6
|
|
Medical Outcome Study (MOS) Short-Form 36-Item Health Survey (SF-36)
Social functioning
|
-0.2 Scores on a scale
Standard Deviation 19.3
|
4.4 Scores on a scale
Standard Deviation 17.0
|
1.1 Scores on a scale
Standard Deviation 18.4
|
4.0 Scores on a scale
Standard Deviation 12.5
|
|
Medical Outcome Study (MOS) Short-Form 36-Item Health Survey (SF-36)
Role emotional
|
-0.1 Scores on a scale
Standard Deviation 18.4
|
5.7 Scores on a scale
Standard Deviation 18.4
|
4.2 Scores on a scale
Standard Deviation 18.7
|
0.7 Scores on a scale
Standard Deviation 16.6
|
SECONDARY outcome
Timeframe: Baseline, every two weeksPopulation: 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). 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. The percentage of subjects with -3 or -4 changes from baseline in each parameter at 6 weeks after dosing is shown.
Outcome measures
| Measure |
Placebo
n=57 Participants
placebo transdermal patch
|
2.25 mg/Day
n=55 Participants
SPM962 maintein dose: 2.25 mg/day
|
4.5 mg/Day
n=56 Participants
SPM962 maintein dose: 4.5mg/day
|
6.75 mg/Day
n=51 Participants
SPM962 maintein dose: 6.75 mg/day
|
|---|---|---|---|---|
|
IRLS Each Parameter
-4 (RLS discomfort)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
3.9 Percentage of Participants
|
|
IRLS Each Parameter
-3 (RLS discomfort)
|
7.0 Percentage of Participants
|
1.8 Percentage of Participants
|
16.1 Percentage of Participants
|
19.6 Percentage of Participants
|
|
IRLS Each Parameter
-4 (need to move around due to RLS symptoms)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
3.6 Percentage of Participants
|
2.0 Percentage of Participants
|
|
IRLS Each Parameter
-3 (need to move around due to RLS symptoms)
|
10.5 Percentage of Participants
|
9.1 Percentage of Participants
|
16.1 Percentage of Participants
|
25.5 Percentage of Participants
|
|
IRLS Each Parameter
-4 (discomfort relief by moving around)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
1.8 Percentage of Participants
|
2.0 Percentage of Participants
|
|
IRLS Each Parameter
-3 (discomfort relief by moving around)
|
7.0 Percentage of Participants
|
9.1 Percentage of Participants
|
26.8 Percentage of Participants
|
13.7 Percentage of Participants
|
|
IRLS Each Parameter
-4 (severity of RLS as a whole)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
2.0 Percentage of Participants
|
|
IRLS Each Parameter
-3 (severity of RLS as a whole)
|
1.8 Percentage of Participants
|
3.6 Percentage of Participants
|
12.5 Percentage of Participants
|
19.6 Percentage of Participants
|
|
IRLS Each Parameter
-4 (RLS symptoms frequency)
|
1.8 Percentage of Participants
|
3.6 Percentage of Participants
|
3.6 Percentage of Participants
|
9.8 Percentage of Participants
|
|
IRLS Each Parameter
-3 (RLS symptoms frequency)
|
7.0 Percentage of Participants
|
7.3 Percentage of Participants
|
26.8 Percentage of Participants
|
19.6 Percentage of Participants
|
|
IRLS Each Parameter
-4 (average duration of RLS symptoms)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
IRLS Each Parameter
-3 (average duration of RLS symptoms)
|
3.5 Percentage of Participants
|
0.0 Percentage of Participants
|
7.1 Percentage of Participants
|
7.8 Percentage of Participants
|
|
IRLS Each Parameter
-4 (severity of sleep disturbance)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
1.8 Percentage of Participants
|
2.0 Percentage of Participants
|
|
IRLS Each Parameter
-3 (severity of sleep disturbance)
|
3.5 Percentage of Participants
|
12.7 Percentage of Participants
|
12.5 Percentage of Participants
|
21.6 Percentage of Participants
|
|
IRLS Each Parameter
-4 (tiredness or sleepiness during the day)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
IRLS Each Parameter
-3 (tiredness or sleepiness during the day)
|
1.8 Percentage of Participants
|
7.3 Percentage of Participants
|
5.4 Percentage of Participants
|
11.8 Percentage of Participants
|
|
IRLS Each Parameter
-4 (severity of impact on daily affaires)
|
0.0 Percentage of Participants
|
1.8 Percentage of Participants
|
1.8 Percentage of Participants
|
2.0 Percentage of Participants
|
|
IRLS Each Parameter
-3 (severity of impact on daily affaires)
|
5.3 Percentage of Participants
|
3.6 Percentage of Participants
|
3.6 Percentage of Participants
|
7.8 Percentage of Participants
|
|
IRLS Each Parameter
-4 (severity of mood disturbance)
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
1.8 Percentage of Participants
|
0.0 Percentage of Participants
|
|
IRLS Each Parameter
-3 (severity of mood disturbance)
|
5.3 Percentage of Participants
|
5.5 Percentage of Participants
|
1.8 Percentage of Participants
|
7.8 Percentage of Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
2.25 mg/Day
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
4.5 mg/Day
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
6.75 mg/Day
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=58 participants at risk
placebo transdermal patch
|
2.25 mg/Day
n=57 participants at risk
SPM962 maintein dose: 2.25 mg/day
|
4.5 mg/Day
n=58 participants at risk
SPM962 maintein dose: 4.5mg/day
|
6.75 mg/Day
n=57 participants at risk
SPM962 maintein dose: 6.75 mg/day
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/58 • 7 weeks
|
0.00%
0/57 • 7 weeks
|
0.00%
0/58 • 7 weeks
|
3.5%
2/57 • Number of events 2 • 7 weeks
|
|
Eye disorders
Photopsia
|
0.00%
0/58 • 7 weeks
|
0.00%
0/57 • 7 weeks
|
3.4%
2/58 • Number of events 2 • 7 weeks
|
0.00%
0/57 • 7 weeks
|
|
Gastrointestinal disorders
Nausea
|
13.8%
8/58 • Number of events 10 • 7 weeks
|
33.3%
19/57 • Number of events 19 • 7 weeks
|
43.1%
25/58 • Number of events 29 • 7 weeks
|
47.4%
27/57 • Number of events 35 • 7 weeks
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/58 • Number of events 1 • 7 weeks
|
7.0%
4/57 • Number of events 6 • 7 weeks
|
10.3%
6/58 • Number of events 7 • 7 weeks
|
19.3%
11/57 • Number of events 14 • 7 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/58 • 7 weeks
|
3.5%
2/57 • Number of events 2 • 7 weeks
|
5.2%
3/58 • Number of events 3 • 7 weeks
|
0.00%
0/57 • 7 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/58 • 7 weeks
|
1.8%
1/57 • Number of events 1 • 7 weeks
|
5.2%
3/58 • Number of events 4 • 7 weeks
|
0.00%
0/57 • 7 weeks
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
3.4%
2/58 • Number of events 2 • 7 weeks
|
3.5%
2/57 • Number of events 2 • 7 weeks
|
1.7%
1/58 • Number of events 1 • 7 weeks
|
0.00%
0/57 • 7 weeks
|
|
Gastrointestinal disorders
Stomach Discomfort
|
1.7%
1/58 • Number of events 1 • 7 weeks
|
3.5%
2/57 • Number of events 2 • 7 weeks
|
0.00%
0/58 • 7 weeks
|
0.00%
0/57 • 7 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/58 • 7 weeks
|
1.8%
1/57 • Number of events 1 • 7 weeks
|
3.4%
2/58 • Number of events 2 • 7 weeks
|
0.00%
0/57 • 7 weeks
|
|
General disorders
Application Site Pruritus
|
3.4%
2/58 • Number of events 2 • 7 weeks
|
14.0%
8/57 • Number of events 8 • 7 weeks
|
19.0%
11/58 • Number of events 11 • 7 weeks
|
17.5%
10/57 • Number of events 10 • 7 weeks
|
|
General disorders
Application Site Reaction
|
8.6%
5/58 • Number of events 5 • 7 weeks
|
10.5%
6/57 • Number of events 6 • 7 weeks
|
13.8%
8/58 • Number of events 8 • 7 weeks
|
12.3%
7/57 • Number of events 8 • 7 weeks
|
|
General disorders
Application Site Erythema
|
6.9%
4/58 • Number of events 4 • 7 weeks
|
7.0%
4/57 • Number of events 4 • 7 weeks
|
12.1%
7/58 • Number of events 7 • 7 weeks
|
12.3%
7/57 • Number of events 7 • 7 weeks
|
|
General disorders
Malaise
|
3.4%
2/58 • Number of events 2 • 7 weeks
|
3.5%
2/57 • Number of events 2 • 7 weeks
|
3.4%
2/58 • Number of events 2 • 7 weeks
|
7.0%
4/57 • Number of events 4 • 7 weeks
|
|
Infections and infestations
Nasopharyngitis
|
24.1%
14/58 • Number of events 17 • 7 weeks
|
21.1%
12/57 • Number of events 13 • 7 weeks
|
25.9%
15/58 • Number of events 15 • 7 weeks
|
24.6%
14/57 • Number of events 18 • 7 weeks
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
1.7%
1/58 • Number of events 1 • 7 weeks
|
1.8%
1/57 • Number of events 1 • 7 weeks
|
5.2%
3/58 • Number of events 3 • 7 weeks
|
0.00%
0/57 • 7 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/58 • 7 weeks
|
1.8%
1/57 • Number of events 1 • 7 weeks
|
1.7%
1/58 • Number of events 1 • 7 weeks
|
7.0%
4/57 • Number of events 4 • 7 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/58 • 7 weeks
|
0.00%
0/57 • 7 weeks
|
3.4%
2/58 • Number of events 2 • 7 weeks
|
3.5%
2/57 • Number of events 2 • 7 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.4%
2/58 • Number of events 2 • 7 weeks
|
1.8%
1/57 • Number of events 1 • 7 weeks
|
0.00%
0/58 • 7 weeks
|
0.00%
0/57 • 7 weeks
|
|
Nervous system disorders
Headache
|
1.7%
1/58 • Number of events 2 • 7 weeks
|
5.3%
3/57 • Number of events 3 • 7 weeks
|
19.0%
11/58 • Number of events 13 • 7 weeks
|
8.8%
5/57 • Number of events 6 • 7 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/58 • 7 weeks
|
3.5%
2/57 • Number of events 2 • 7 weeks
|
6.9%
4/58 • Number of events 5 • 7 weeks
|
3.5%
2/57 • Number of events 2 • 7 weeks
|
|
Psychiatric disorders
Somnolence
|
5.2%
3/58 • Number of events 3 • 7 weeks
|
10.5%
6/57 • Number of events 6 • 7 weeks
|
19.0%
11/58 • Number of events 13 • 7 weeks
|
21.1%
12/57 • Number of events 12 • 7 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/58 • 7 weeks
|
0.00%
0/57 • 7 weeks
|
0.00%
0/58 • 7 weeks
|
3.5%
2/57 • Number of events 2 • 7 weeks
|
|
Reproductive system and breast disorders
Menses Irregular
|
0.00%
0/58 • 7 weeks
|
1.8%
1/57 • Number of events 1 • 7 weeks
|
3.4%
2/58 • Number of events 2 • 7 weeks
|
0.00%
0/57 • 7 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.4%
2/58 • Number of events 2 • 7 weeks
|
5.3%
3/57 • Number of events 3 • 7 weeks
|
0.00%
0/58 • 7 weeks
|
0.00%
0/57 • 7 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