Trial Outcomes & Findings for A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients (NCT NCT01628926)
NCT ID: NCT01628926
Last Updated: 2014-05-23
Results Overview
Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 16 weeks after dosing. UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.
COMPLETED
PHASE3
420 participants
baseline, 16 weeks after dosing
2014-05-23
Participant Flow
Participant milestones
| Measure |
SPM 962
SPM 962 transdermal patch
|
Ropinirole
Ropinirole tablet
|
Placebo
SPM962 placebo patch and Ropinirole placebo tab
|
|---|---|---|---|
|
Overall Study
STARTED
|
168
|
167
|
85
|
|
Overall Study
COMPLETED
|
142
|
144
|
68
|
|
Overall Study
NOT COMPLETED
|
26
|
23
|
17
|
Reasons for withdrawal
| Measure |
SPM 962
SPM 962 transdermal patch
|
Ropinirole
Ropinirole tablet
|
Placebo
SPM962 placebo patch and Ropinirole placebo tab
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
13
|
11
|
9
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
5
|
|
Overall Study
Withdrawal by Subject
|
6
|
4
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Discontinuation criteria
|
3
|
4
|
0
|
|
Overall Study
Physician Decision
|
2
|
2
|
1
|
Baseline Characteristics
A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients
Baseline characteristics by cohort
| Measure |
SPM 962
n=164 Participants
SPM 962 transdermal patch
|
Ropinirole
n=166 Participants
Ropinirole tablet
|
Placebo
n=84 Participants
SPM962 placebo patch and Ropinirole placebo tab
|
Total
n=414 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
71 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
151 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
93 Participants
n=99 Participants
|
114 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
263 Participants
n=7 Participants
|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 8.8 • n=99 Participants
|
67.0 years
STANDARD_DEVIATION 7.9 • n=107 Participants
|
65.3 years
STANDARD_DEVIATION 7.9 • n=206 Participants
|
65.8 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=99 Participants
|
98 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
243 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
171 Participants
n=7 Participants
|
|
Region of Enrollment
Japan
|
164 participants
n=99 Participants
|
166 participants
n=107 Participants
|
84 participants
n=206 Participants
|
414 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: baseline, 16 weeks after dosingPopulation: Full analysis set (FAS), last observation carried forward (LOCF)
Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 16 weeks after dosing. UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.
Outcome measures
| Measure |
SPM 962
n=164 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
Ropinirole
n=166 Participants
Ropinirole oral administration TID up to 15.0 mg/day
|
Placebo
n=84 Participants
SPM962-placebo patch and Ropinirole-placebo tab
|
|---|---|---|---|
|
Unified Parkinson's Disease Rating Score (UPDRS) Part 3 Sum Score
|
-10.9 Scores on a scale
Standard Deviation 8.1
|
-9.5 Scores on a scale
Standard Deviation 8.7
|
-4.5 Scores on a scale
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: baseline, 8 and 10 weeks after dosingPopulation: FAS, LOCF
Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 8 and 10 weeks after dosing. UPDRS Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.
Outcome measures
| Measure |
SPM 962
n=164 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
Ropinirole
n=166 Participants
Ropinirole oral administration TID up to 15.0 mg/day
|
Placebo
n=84 Participants
SPM962-placebo patch and Ropinirole-placebo tab
|
|---|---|---|---|
|
UPDRS Part 3 Sum Score
8 weeks after dosing
|
-9.7 Scores on a scale
Standard Deviation 7.2
|
-8.4 Scores on a scale
Standard Deviation 8.1
|
-5.5 Scores on a scale
Standard Deviation 8.3
|
|
UPDRS Part 3 Sum Score
10 weeks after dosing
|
-9.9 Scores on a scale
Standard Deviation 7.1
|
-8.8 Scores on a scale
Standard Deviation 8.3
|
-5.3 Scores on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks after dosingPopulation: FAS, LOCF
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) at 16 weeks after dosing. UPDRS 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.
Outcome measures
| Measure |
SPM 962
n=163 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
Ropinirole
n=166 Participants
Ropinirole oral administration TID up to 15.0 mg/day
|
Placebo
n=84 Participants
SPM962-placebo patch and Ropinirole-placebo tab
|
|---|---|---|---|
|
UPDRS Part 2 Sum Score
|
-3.6 Scores on a scale
Standard Deviation 4.1
|
-2.9 Scores on a scale
Standard Deviation 3.5
|
-1.3 Scores on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks after dosingPopulation: FAS subjects with measurable off time data at baseline, LOCF
Mean change (LOCF) from baseline in off time at 16 weeks after dosing. Off-time is a state where L-Dopa becomes ineffective. Off-time was measured by patient diary in hours/day.
Outcome measures
| Measure |
SPM 962
n=111 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
Ropinirole
n=113 Participants
Ropinirole oral administration TID up to 15.0 mg/day
|
Placebo
n=57 Participants
SPM962-placebo patch and Ropinirole-placebo tab
|
|---|---|---|---|
|
Off Time
|
-1.3 Hours/day
Standard Deviation 2.9
|
-2.0 Hours/day
Standard Deviation 3.0
|
-0.4 Hours/day
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks after dosingPopulation: FAS, LOCF
Mean change (LOCF) from baseline in PDSS-2 sum score at 16 weeks after dosing. PDSS-2 is a scale for assessing sleep disorders in Parkinson's disease. PDSS consists of 15 questions about sleep and nocturnal disturbances. The score of each question ranges from 0 (never) to 4 (very frequent). The sum of each question serves as the scale score. Thus a decrease in the scores means improvement.
Outcome measures
| Measure |
SPM 962
n=162 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
Ropinirole
n=165 Participants
Ropinirole oral administration TID up to 15.0 mg/day
|
Placebo
n=81 Participants
SPM962-placebo patch and Ropinirole-placebo tab
|
|---|---|---|---|
|
Parkinson's Disease Sleep Scale-2 (PDSS-2)
|
-3.1 Scores on a scale
Standard Deviation 6.8
|
-3.4 Scores on a scale
Standard Deviation 7.6
|
-1.8 Scores on a scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks after dosingPopulation: FAS, LOCF
Mean change (LOCF) from baseline in on time at 16 weeks after dosing. On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day.
Outcome measures
| Measure |
SPM 962
n=164 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
Ropinirole
n=165 Participants
Ropinirole oral administration TID up to 15.0 mg/day
|
Placebo
n=83 Participants
SPM962-placebo patch and Ropinirole-placebo tab
|
|---|---|---|---|
|
On Time
|
1.3 Hours/day
Standard Deviation 2.7
|
1.7 Hours/day
Standard Deviation 2.9
|
0.2 Hours/day
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks after dosingPopulation: FAS, LOCF Evaluation for this outcome measure was not possible, because only 22.6% (37/164), 12.7% (21/165), and 6.0% (5/83) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had dyskinesia disturbing daily activities on either day from baseline until the end of titration/maintenance.
Mean change (LOCF) from baseline in on time without dyskinesia disturbing daily activities at 16 weeks after dosing. On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day.
Outcome measures
| Measure |
SPM 962
n=164 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
Ropinirole
n=165 Participants
Ropinirole oral administration TID up to 15.0 mg/day
|
Placebo
n=83 Participants
SPM962-placebo patch and Ropinirole-placebo tab
|
|---|---|---|---|
|
On Time Without Dyskinesia Disturbing Daily Activities
|
1.1 Hours/day
Standard Deviation 2.9
|
1.6 Hours/day
Standard Deviation 3.0
|
0.3 Hours/day
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks after dosingPopulation: FAS, LOCF Evaluation for this outcome measure was not possible, because only 22.6% (37/164), 12.7% (21/165), and 6.0% (5/83) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had dyskinesia disturbing daily activities on either day from baseline until the end of titration/maintenance period.
Mean change (LOCF) from baseline in on time with dyskinesia disturbing daily activities at 16 weeks after dosing (rate against on time).
Outcome measures
| Measure |
SPM 962
n=37 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
Ropinirole
n=21 Participants
Ropinirole oral administration TID up to 15.0 mg/day
|
Placebo
n=5 Participants
SPM962-placebo patch and Ropinirole-placebo tab
|
|---|---|---|---|
|
On Time With Dyskinesia Disturbing Daily Activities
|
1.3 Hours
Standard Deviation 11.0
|
0.6 Hours
Standard Deviation 7.8
|
-0.2 Hours
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks after dosingPopulation: FAS, LOCF
Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 3 sum score (on state) at 16 weeks after dosing.
Outcome measures
| Measure |
SPM 962
n=164 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
Ropinirole
n=166 Participants
Ropinirole oral administration TID up to 15.0 mg/day
|
Placebo
n=84 Participants
SPM962-placebo patch and Ropinirole-placebo tab
|
|---|---|---|---|
|
Effective Rate in UPDRS Part 3 Sum Score
≥20% decrease
|
80.5 Percentage of participants
Interval 74.4 to 86.6
|
69.1 Percentage of participants
Interval 62.0 to 76.1
|
56.6 Percentage of participants
Interval 46.0 to 67.3
|
|
Effective Rate in UPDRS Part 3 Sum Score
≥30% decrease
|
69.5 Percentage of participants
Interval 62.5 to 76.6
|
60.6 Percentage of participants
Interval 53.2 to 68.1
|
39.8 Percentage of participants
Interval 29.2 to 50.3
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks after dosingPopulation: FAS, LOCF
Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score (average scores of on state and off state) at 16 weeks after dosing.
Outcome measures
| Measure |
SPM 962
n=163 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
Ropinirole
n=166 Participants
Ropinirole oral administration TID up to 15.0 mg/day
|
Placebo
n=84 Participants
SPM962-placebo patch and Ropinirole-placebo tab
|
|---|---|---|---|
|
Effective Rate in UPDRS Part 2 Sum Score
≥30% decrease
|
55.9 Percentage of participants
Interval 48.2 to 63.6
|
43.3 Percentage of participants
Interval 35.7 to 50.9
|
28.9 Percentage of participants
Interval 19.2 to 38.7
|
|
Effective Rate in UPDRS Part 2 Sum Score
≥20% decrease
|
65.2 Percentage of participants
Interval 57.9 to 72.6
|
56.7 Percentage of participants
Interval 49.1 to 64.3
|
47.0 Percentage of participants
Interval 36.3 to 57.7
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks after dosingPopulation: FAS subjects with measurable off time data at baseline, LOCF
Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in off time at 16 weeks after dosing. On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day.
Outcome measures
| Measure |
SPM 962
n=111 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
Ropinirole
n=113 Participants
Ropinirole oral administration TID up to 15.0 mg/day
|
Placebo
n=57 Participants
SPM962-placebo patch and Ropinirole-placebo tab
|
|---|---|---|---|
|
Effective Rate in Off Time
≥20% decrease
|
61.8 Percentage of participants
Interval 52.7 to 70.9
|
65.5 Percentage of participants
Interval 56.7 to 74.3
|
47.4 Percentage of participants
Interval 34.4 to 60.3
|
|
Effective Rate in Off Time
≥30% decrease
|
55.5 Percentage of participants
Interval 46.2 to 64.7
|
61.9 Percentage of participants
Interval 53.0 to 70.9
|
40.4 Percentage of participants
Interval 27.6 to 53.1
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks after dosingPopulation: FAS, LOCF
Change (LOCF) from baseline in CGI score. 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. A decrease in the scores means improvement.
Outcome measures
| Measure |
SPM 962
n=163 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
Ropinirole
n=165 Participants
Ropinirole oral administration TID up to 15.0 mg/day
|
Placebo
n=81 Participants
SPM962-placebo patch and Ropinirole-placebo tab
|
|---|---|---|---|
|
Clinical Global Impression (CGI)
Increased
|
3.1 Percentage of Participants
|
4.2 Percentage of Participants
|
4.9 Percentage of Participants
|
|
Clinical Global Impression (CGI)
Increased (by at least 2 points)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Clinical Global Impression (CGI)
Decreased
|
50.3 Percentage of Participants
|
49.1 Percentage of Participants
|
30.9 Percentage of Participants
|
|
Clinical Global Impression (CGI)
Decreased (by at least 2 points)
|
8.0 Percentage of Participants
|
8.5 Percentage of Participants
|
3.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks after dosingPopulation: FAS, LOCF Evaluation for this outcome measure was not possible, because 87.1% (142/163), 88.5% (146/165), and 91.4% (74/81) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had no dystonia in the day time at baseline.
Change (LOCF) from baseline in occurrence of Dystonia (at an early hour).
Outcome measures
| Measure |
SPM 962
n=163 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
Ropinirole
n=165 Participants
Ropinirole oral administration TID up to 15.0 mg/day
|
Placebo
n=81 Participants
SPM962-placebo patch and Ropinirole-placebo tab
|
|---|---|---|---|
|
Dystonia (at an Early Hour)
Decreased
|
10.4 Percentage of participants
|
10.9 Percentage of participants
|
7.4 Percentage of participants
|
|
Dystonia (at an Early Hour)
Decreased (by at least 2 events)
|
1.8 Percentage of participants
|
4.2 Percentage of participants
|
2.5 Percentage of participants
|
|
Dystonia (at an Early Hour)
Increased
|
1.2 Percentage of participants
|
3.0 Percentage of participants
|
3.7 Percentage of participants
|
|
Dystonia (at an Early Hour)
Increased (by at least 2 events)
|
0 Percentage of participants
|
0.6 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks after dosingPopulation: Appropriate interpretation for this outcome measure was not possible, because 87.1% (142/163), 88.5% (146/165), and 91.4% (74/81) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had no dystonia in the day time at baseline.
Change (LOCF) from baseline in occurrence of Dystonia (in the daytime).
Outcome measures
| Measure |
SPM 962
n=163 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
Ropinirole
n=165 Participants
Ropinirole oral administration TID up to 15.0 mg/day
|
Placebo
n=81 Participants
SPM962-placebo patch and Ropinirole-placebo tab
|
|---|---|---|---|
|
Dystonia (in the Daytime)
Increased
|
3.7 Percentage of Participants
|
2.4 Percentage of Participants
|
4.9 Percentage of Participants
|
|
Dystonia (in the Daytime)
Increased (by at least 2 events)
|
1.8 Percentage of Participants
|
0.6 Percentage of Participants
|
1.2 Percentage of Participants
|
|
Dystonia (in the Daytime)
Decreased
|
8.6 Percentage of Participants
|
7.9 Percentage of Participants
|
3.7 Percentage of Participants
|
|
Dystonia (in the Daytime)
Decreased (by at least 2 events)
|
3.7 Percentage of Participants
|
5.5 Percentage of Participants
|
2.5 Percentage of Participants
|
Adverse Events
SPM 962
Ropinirole
Placebo
Serious adverse events
| Measure |
SPM 962
n=168 participants at risk
SPM 962 transdermal patch
|
Ropinirole
n=167 participants at risk
Ropinirole tablet
|
Placebo
n=85 participants at risk
SPM962 placebo patch and Ropinirole placebo tab
|
|---|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/168 • 21 weeks
|
0.00%
0/167 • 21 weeks
|
1.2%
1/85 • Number of events 1 • 21 weeks
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.60%
1/168 • Number of events 1 • 21 weeks
|
0.00%
0/167 • 21 weeks
|
0.00%
0/85 • 21 weeks
|
|
Gastrointestinal disorders
Gastric Ulcer Bleeding
|
0.00%
0/168 • 21 weeks
|
0.60%
1/167 • Number of events 1 • 21 weeks
|
0.00%
0/85 • 21 weeks
|
|
Gastrointestinal disorders
Ileus
|
0.60%
1/168 • Number of events 1 • 21 weeks
|
0.00%
0/167 • 21 weeks
|
0.00%
0/85 • 21 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/168 • 21 weeks
|
0.60%
1/167 • Number of events 1 • 21 weeks
|
0.00%
0/85 • 21 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/168 • 21 weeks
|
0.60%
1/167 • Number of events 1 • 21 weeks
|
0.00%
0/85 • 21 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/168 • 21 weeks
|
0.00%
0/167 • 21 weeks
|
1.2%
1/85 • Number of events 1 • 21 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/168 • 21 weeks
|
0.00%
0/167 • 21 weeks
|
1.2%
1/85 • Number of events 1 • 21 weeks
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.60%
1/168 • Number of events 1 • 21 weeks
|
0.00%
0/167 • 21 weeks
|
1.2%
1/85 • Number of events 1 • 21 weeks
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.60%
1/168 • Number of events 1 • 21 weeks
|
0.00%
0/167 • 21 weeks
|
0.00%
0/85 • 21 weeks
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.60%
1/168 • Number of events 1 • 21 weeks
|
0.00%
0/167 • 21 weeks
|
0.00%
0/85 • 21 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma Gastric
|
0.00%
0/168 • 21 weeks
|
0.00%
0/167 • 21 weeks
|
1.2%
1/85 • Number of events 1 • 21 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/168 • 21 weeks
|
0.60%
1/167 • Number of events 1 • 21 weeks
|
0.00%
0/85 • 21 weeks
|
|
Nervous system disorders
Posture Abnormal
|
0.60%
1/168 • Number of events 1 • 21 weeks
|
0.00%
0/167 • 21 weeks
|
0.00%
0/85 • 21 weeks
|
|
Nervous system disorders
Disease Parkinson's
|
0.60%
1/168 • Number of events 1 • 21 weeks
|
0.60%
1/167 • Number of events 1 • 21 weeks
|
1.2%
1/85 • Number of events 1 • 21 weeks
|
|
Nervous system disorders
Cerebral Artery Embolism
|
0.00%
0/168 • 21 weeks
|
0.00%
0/167 • 21 weeks
|
1.2%
1/85 • Number of events 1 • 21 weeks
|
|
Psychiatric disorders
Delusion
|
0.00%
0/168 • 21 weeks
|
0.60%
1/167 • Number of events 1 • 21 weeks
|
0.00%
0/85 • 21 weeks
|
|
Renal and urinary disorders
Caruncle Urethral
|
0.60%
1/168 • Number of events 1 • 21 weeks
|
0.00%
0/167 • 21 weeks
|
0.00%
0/85 • 21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Embolism Pulmonary
|
0.00%
0/168 • 21 weeks
|
0.00%
0/167 • 21 weeks
|
1.2%
1/85 • Number of events 1 • 21 weeks
|
Other adverse events
| Measure |
SPM 962
n=168 participants at risk
SPM 962 transdermal patch
|
Ropinirole
n=167 participants at risk
Ropinirole tablet
|
Placebo
n=85 participants at risk
SPM962 placebo patch and Ropinirole placebo tab
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
14.9%
25/168 • Number of events 27 • 21 weeks
|
13.8%
23/167 • Number of events 26 • 21 weeks
|
8.2%
7/85 • Number of events 8 • 21 weeks
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
11/168 • Number of events 15 • 21 weeks
|
6.6%
11/167 • Number of events 13 • 21 weeks
|
2.4%
2/85 • Number of events 2 • 21 weeks
|
|
General disorders
Application Site Reaction
|
54.2%
91/168 • Number of events 93 • 21 weeks
|
18.0%
30/167 • Number of events 33 • 21 weeks
|
11.8%
10/85 • Number of events 11 • 21 weeks
|
|
General disorders
Application Site Pruritus
|
3.6%
6/168 • Number of events 7 • 21 weeks
|
0.00%
0/167 • 21 weeks
|
0.00%
0/85 • 21 weeks
|
|
General disorders
Oedema Peripheral
|
0.00%
0/168 • 21 weeks
|
1.2%
2/167 • Number of events 2 • 21 weeks
|
3.5%
3/85 • Number of events 3 • 21 weeks
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
28/168 • Number of events 38 • 21 weeks
|
14.4%
24/167 • Number of events 29 • 21 weeks
|
15.3%
13/85 • Number of events 17 • 21 weeks
|
|
Infections and infestations
Cystitis
|
1.8%
3/168 • Number of events 3 • 21 weeks
|
1.8%
3/167 • Number of events 3 • 21 weeks
|
4.7%
4/85 • Number of events 5 • 21 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
4.2%
7/168 • Number of events 7 • 21 weeks
|
1.2%
2/167 • Number of events 2 • 21 weeks
|
7.1%
6/85 • Number of events 8 • 21 weeks
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
3.0%
5/168 • Number of events 5 • 21 weeks
|
3.6%
6/167 • Number of events 6 • 21 weeks
|
1.2%
1/85 • Number of events 2 • 21 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.8%
3/168 • Number of events 3 • 21 weeks
|
3.0%
5/167 • Number of events 5 • 21 weeks
|
2.4%
2/85 • Number of events 2 • 21 weeks
|
|
Nervous system disorders
Dyskinesia
|
16.1%
27/168 • Number of events 28 • 21 weeks
|
13.8%
23/167 • Number of events 23 • 21 weeks
|
1.2%
1/85 • Number of events 1 • 21 weeks
|
|
Psychiatric disorders
Hallucination Visual
|
7.7%
13/168 • Number of events 14 • 21 weeks
|
6.0%
10/167 • Number of events 10 • 21 weeks
|
3.5%
3/85 • Number of events 3 • 21 weeks
|
|
Psychiatric disorders
Somnolence
|
6.5%
11/168 • Number of events 11 • 21 weeks
|
5.4%
9/167 • Number of events 9 • 21 weeks
|
2.4%
2/85 • Number of events 2 • 21 weeks
|
|
Psychiatric disorders
Hallucination
|
1.8%
3/168 • Number of events 3 • 21 weeks
|
3.6%
6/167 • Number of events 6 • 21 weeks
|
0.00%
0/85 • 21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
1.8%
3/168 • Number of events 4 • 21 weeks
|
0.60%
1/167 • Number of events 1 • 21 weeks
|
3.5%
3/85 • Number of events 4 • 21 weeks
|
|
Vascular disorders
Orthostatic Hypotension
|
3.0%
5/168 • Number of events 5 • 21 weeks
|
4.2%
7/167 • Number of events 8 • 21 weeks
|
4.7%
4/85 • Number of events 5 • 21 weeks
|
Additional Information
Director of Clinical Research and Development
Otsuka Pharmaceutical Co, Lts.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place