Trial Outcomes & Findings for A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients (NCT NCT00537485)

NCT ID: NCT00537485

Last Updated: 2014-03-19

Results Overview

Mean change (LOCF) from baseline to the end of maintenance period in total of each sum score of UPDRS Part 2 and Part 3. 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 2 assesses 13 items and 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.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 180 participants
• Primary outcome timeframe: baseline, end of maintenance period
• Results posted on: 2014-03-19

Participant Flow

Participant milestones

Measure	SPM962 transdermal application of SPM962, 1 time per day	Placebo transdermal application of placebo, 1 time per day
Overall Study STARTED	90	90
Overall Study COMPLETED	75	80
Overall Study NOT COMPLETED	15	10

Reasons for withdrawal

Measure	SPM962 transdermal application of SPM962, 1 time per day	Placebo transdermal application of placebo, 1 time per day
Overall Study Adverse Event	10	5
Overall Study Withdrawal by Subject	1	3
Overall Study Physician Decision	1	0

Baseline Characteristics

A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients

Baseline characteristics by cohort

Measure	SPM962 n=88 Participants transdermal application of SPM962, 1 time per day	Placebo n=88 Participants transdermal application of placebo, 1 time per day	Total n=176 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=93 Participants	35 Participants n=4 Participants	71 Participants n=27 Participants
Age, Categorical >=65 years	52 Participants n=93 Participants	53 Participants n=4 Participants	105 Participants n=27 Participants
Age, Continuous	65.1 years STANDARD_DEVIATION 8.1 • n=93 Participants	66.2 years STANDARD_DEVIATION 7.9 • n=4 Participants	65.6 years STANDARD_DEVIATION 8.0 • n=27 Participants
Sex: Female, Male Female	55 Participants n=93 Participants	51 Participants n=4 Participants	106 Participants n=27 Participants
Sex: Female, Male Male	33 Participants n=93 Participants	37 Participants n=4 Participants	70 Participants n=27 Participants
Region of Enrollment Japan	88 participants n=93 Participants	88 participants n=4 Participants	176 participants n=27 Participants

PRIMARY outcome

Timeframe: baseline, end of maintenance period

Population: Full analysis set (FAS), last observation carried forward (LOCF)

Mean change (LOCF) from baseline to the end of maintenance period in total of each sum score of UPDRS Part 2 and Part 3.

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 2 assesses 13 items and 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	SPM962 n=88 Participants transdermal application of SPM962, 1 time per day	Placebo n=88 Participants transdermal application of placebo, 1 time per day
Change From Baseline to the End of Maintenance Period in Total of Each Sum Score of UPDRS Part 2 and Part 3	-8.4 Scores on a scale Standard Deviation 9.7	-4.1 Scores on a scale Standard Deviation 8.2

SECONDARY outcome

Timeframe: baseline, end of maintenance period

Population: FAS, LOCF

Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in total of each sum score of UPDRS Part 2 and Part 3 at the end of maintenance period

Outcome measures

Measure	SPM962 n=88 Participants transdermal application of SPM962, 1 time per day	Placebo n=88 Participants transdermal application of placebo, 1 time per day
Efficacy Rate in Total of Each Sum Score of UPDRS Part 2 and Part 3 ≥20% decrease	71.6 Percentage of participants Interval 62.2 to 81.0	40.9 Percentage of participants Interval 30.6 to 51.3
Efficacy Rate in Total of Each Sum Score of UPDRS Part 2 and Part 3 ≥30% decrease	55.7 Percentage of participants Interval 45.3 to 66.1	29.5 Percentage of participants Interval 20.0 to 39.1

SECONDARY outcome

Timeframe: Baseline, every two weeks

Mean change (LOCF) from baseline in UPDRS Part 2 sum score at every two weeks after dosing.

UPDRS sub-scale Part 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	SPM962 n=88 Participants transdermal application of SPM962, 1 time per day	Placebo n=88 Participants transdermal application of placebo, 1 time per day
Mean Change in UPDRS Part 2 Sum Score Week 2	-0.6 Scores on a scale Standard Deviation 2.1	-0.5 Scores on a scale Standard Deviation 1.3
Mean Change in UPDRS Part 2 Sum Score Week 4	-1.2 Scores on a scale Standard Deviation 2.7	-1.0 Scores on a scale Standard Deviation 1.9
Mean Change in UPDRS Part 2 Sum Score Week 6	-1.6 Scores on a scale Standard Deviation 2.9	-1.4 Scores on a scale Standard Deviation 2.1
Mean Change in UPDRS Part 2 Sum Score Week 8	-1.6 Scores on a scale Standard Deviation 3.3	-1.3 Scores on a scale Standard Deviation 2.4
Mean Change in UPDRS Part 2 Sum Score Week 10	-1.7 Scores on a scale Standard Deviation 3.2	-1.2 Scores on a scale Standard Deviation 2.7
Mean Change in UPDRS Part 2 Sum Score Week 12	-1.8 Scores on a scale Standard Deviation 3.2	-1.1 Scores on a scale Standard Deviation 2.9
Mean Change in UPDRS Part 2 Sum Score End of maintenance period	-1.8 Scores on a scale Standard Deviation 3.3	-1.1 Scores on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: Baseline, every two weeks

Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score at every two weeks after dosing.

Outcome measures

Measure	SPM962 n=88 Participants transdermal application of SPM962, 1 time per day	Placebo n=88 Participants transdermal application of placebo, 1 time per day
Efficacy Rate in UPDRS Part 2 Sum Score ≥20% decrease (Week 2)	36.4 Percentage of participants Interval 26.3 to 46.4	13.6 Percentage of participants Interval 6.5 to 20.8
Efficacy Rate in UPDRS Part 2 Sum Score ≥20% decrease (Week 4)	46.6 Percentage of participants Interval 36.2 to 57.0	34.1 Percentage of participants Interval 24.2 to 44.0
Efficacy Rate in UPDRS Part 2 Sum Score ≥20% decrease (Week 6)	52.3 Percentage of participants Interval 41.8 to 62.7	40.9 Percentage of participants Interval 30.6 to 51.2
Efficacy Rate in UPDRS Part 2 Sum Score ≥20% decrease (Week 8)	56.8 Percentage of participants Interval 46.5 to 67.2	43.2 Percentage of participants Interval 32.8 to 53.5
Efficacy Rate in UPDRS Part 2 Sum Score ≥20% decrease (Week 10)	58.0 Percentage of participants Interval 47.6 to 68.3	38.6 Percentage of participants Interval 28.5 to 48.8
Efficacy Rate in UPDRS Part 2 Sum Score ≥20% decrease (Week 12)	61.4 Percentage of participants Interval 51.2 to 71.5	39.8 Percentage of participants Interval 29.5 to 50.0
Efficacy Rate in UPDRS Part 2 Sum Score ≥20% decrease (End of maintenance period)	60.2 Percentage of participants Interval 50.0 to 70.5	39.8 Percentage of participants Interval 29.5 to 50.0
Efficacy Rate in UPDRS Part 2 Sum Score ≥30% decrease (Week 2)	20.5 Percentage of participants Interval 12.0 to 28.9	13.6 Percentage of participants Interval 6.5 to 20.8
Efficacy Rate in UPDRS Part 2 Sum Score ≥30% decrease (Week 4)	36.4 Percentage of participants Interval 26.3 to 46.4	19.3 Percentage of participants Interval 11.1 to 27.6
Efficacy Rate in UPDRS Part 2 Sum Score ≥30% decrease (Week 6)	43.2 Percentage of participants Interval 32.8 to 53.5	28.4 Percentage of participants Interval 19.0 to 37.8
Efficacy Rate in UPDRS Part 2 Sum Score ≥30% decrease (Week 8)	43.2 Percentage of participants Interval 32.8 to 53.5	25.0 Percentage of participants Interval 16.0 to 34.0
Efficacy Rate in UPDRS Part 2 Sum Score ≥30% decrease (Week 10)	43.2 Percentage of participants Interval 32.8 to 53.5	29.5 Percentage of participants Interval 20.0 to 39.1
Efficacy Rate in UPDRS Part 2 Sum Score ≥30% decrease (Week 12)	48.9 Percentage of participants Interval 38.4 to 59.3	26.1 Percentage of participants Interval 17.0 to 35.3
Efficacy Rate in UPDRS Part 2 Sum Score ≥30% decrease (End of maintenance period)	48.9 Percentage of participants Interval 38.4 to 59.3	26.1 Percentage of participants Interval 17.0 to 35.3

SECONDARY outcome

Timeframe: Baseline, every two weeks

Population: FAS, LOCF

Mean change (LOCF) from baseline in UPDRS Part 3 sum score at every two weeks after dosing.

UPDRS sub-scale 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	SPM962 n=88 Participants transdermal application of SPM962, 1 time per day	Placebo n=88 Participants transdermal application of placebo, 1 time per day
UPDRS Part 3 Sum Score Week 2	-2.6 Scores on a scale Standard Deviation 4.2	-1.7 Scores on a scale Standard Deviation 3.9
UPDRS Part 3 Sum Score Week 4	-4.3 Scores on a scale Standard Deviation 5.2	-2.7 Scores on a scale Standard Deviation 4.7
UPDRS Part 3 Sum Score Week 6	-5.7 Scores on a scale Standard Deviation 6.3	-3.3 Scores on a scale Standard Deviation 5.3
UPDRS Part 3 Sum Score Week 8	-6.1 Scores on a scale Standard Deviation 6.7	-3.3 Scores on a scale Standard Deviation 5.8
UPDRS Part 3 Sum Score Week 10	-6.4 Scores on a scale Standard Deviation 6.7	-3.4 Scores on a scale Standard Deviation 5.8
UPDRS Part 3 Sum Score Week 12	-6.6 Scores on a scale Standard Deviation 7.2	-3.1 Scores on a scale Standard Deviation 6.2
UPDRS Part 3 Sum Score End of maintenance period	-6.6 Scores on a scale Standard Deviation 7.2	-3.0 Scores on a scale Standard Deviation 6.2

SECONDARY outcome

Timeframe: Baseline, every two weeks

Population: FAS, LOCF

Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score at every two weeks after dosing.

Outcome measures

Measure	SPM962 n=88 Participants transdermal application of SPM962, 1 time per day	Placebo n=88 Participants transdermal application of placebo, 1 time per day
Efficacy Rate in UPDRS Part 3 Sum Score ≥20% decrease (Week 2)	35.2 Percentage of participants Interval 25.2 to 45.2	19.3 Percentage of participants Interval 11.1 to 27.6
Efficacy Rate in UPDRS Part 3 Sum Score ≥20% decrease (Week 4)	52.3 Percentage of participants Interval 41.8 to 62.7	28.4 Percentage of participants Interval 19.0 to 37.8
Efficacy Rate in UPDRS Part 3 Sum Score ≥20% decrease (Week 6)	62.5 Percentage of participants Interval 52.4 to 72.6	35.2 Percentage of participants Interval 25.2 to 45.2
Efficacy Rate in UPDRS Part 3 Sum Score ≥20% decrease (Week 8)	67.0 Percentage of participants Interval 57.2 to 76.9	37.0 Percentage of participants Interval 27.4 to 47.6
Efficacy Rate in UPDRS Part 3 Sum Score ≥20% decrease (Week 10)	70.5 Percentage of participants Interval 60.9 to 80.0	42.0 Percentage of participants Interval 31.7 to 52.4
Efficacy Rate in UPDRS Part 3 Sum Score ≥20% decrease (Week 12)	70.5 Percentage of participants Interval 60.9 to 80.0	40.9 Percentage of participants Interval 30.6 to 51.2
Efficacy Rate in UPDRS Part 3 Sum Score ≥20% decrease (End of maintenance period)	70.5 Percentage of participants Interval 60.9 to 80.0	40.9 Percentage of participants Interval 30.6 to 51.2
Efficacy Rate in UPDRS Part 3 Sum Score ≥30% decrease (Week 2)	22.7 Percentage of participants Interval 14.0 to 31.5	15.9 Percentage of participants Interval 8.3 to 23.6
Efficacy Rate in UPDRS Part 3 Sum Score ≥30% decrease (Week 4)	36.4 Percentage of participants Interval 26.3 to 46.4	21.6 Percentage of participants Interval 13.0 to 30.2
Efficacy Rate in UPDRS Part 3 Sum Score ≥30% decrease (Week 6)	52.3 Percentage of participants Interval 41.8 to 62.7	23.9 Percentage of participants Interval 15.0 to 32.8
Efficacy Rate in UPDRS Part 3 Sum Score ≥30% decrease (Week 8)	54.5 Percentage of participants Interval 44.1 to 64.9	28.4 Percentage of participants Interval 19.0 to 37.8
Efficacy Rate in UPDRS Part 3 Sum Score ≥30% decrease (Week 10)	58.0 Percentage of participants Interval 47.6 to 68.3	29.5 Percentage of participants Interval 20.0 to 39.1
Efficacy Rate in UPDRS Part 3 Sum Score ≥30% decrease (Week 12)	60.2 Percentage of participants Interval 50.0 to 70.5	28.4 Percentage of participants Interval 19.0 to 37.8
Efficacy Rate in UPDRS Part 3 Sum Score ≥30% decrease (End of maintenance period)	60.2 Percentage of participants Interval 50.0 to 70.5	28.4 Percentage of participants Interval 19.0 to 37.8

SECONDARY outcome

Timeframe: Baseline, every two weeks

Population: FAS, LOCF

MMean change (LOCF) from baseline in UPDRS Part 1 sum score at every two weeks after dosing.

UPDRS sub-scale Part 1 assesses 4 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	SPM962 n=88 Participants transdermal application of SPM962, 1 time per day	Placebo n=88 Participants transdermal application of placebo, 1 time per day
UPDRS Part 1 Sum Score Week 2	-0.17 Scores on a scale Standard Deviation 0.46	-0.01 Scores on a scale Standard Deviation 0.28
UPDRS Part 1 Sum Score Week 4	-0.17 Scores on a scale Standard Deviation 0.75	-0.11 Scores on a scale Standard Deviation 0.49
UPDRS Part 1 Sum Score Week 6	-0.14 Scores on a scale Standard Deviation 0.89	-0.13 Scores on a scale Standard Deviation 0.58
UPDRS Part 1 Sum Score Week 8	-0.23 Scores on a scale Standard Deviation 0.89	-0.07 Scores on a scale Standard Deviation 0.56
UPDRS Part 1 Sum Score Week 10	-0.25 Scores on a scale Standard Deviation 0.91	-0.11 Scores on a scale Standard Deviation 0.63
UPDRS Part 1 Sum Score Week 12	-0.25 Scores on a scale Standard Deviation 0.91	-0.05 Scores on a scale Standard Deviation 0.88
UPDRS Part 1 Sum Score End of maintenance period	-0.25 Scores on a scale Standard Deviation 0.91	-0.05 Scores on a scale Standard Deviation 0.88

SECONDARY outcome

Timeframe: Baseline, every two weeks

Population: FAS, LOCF

Mean change (LOCF) from baseline in UPDRS Part 4 sum score at every two weeks after dosing.

UPDRS sub-scale Part 4 assesses 11 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	SPM962 n=88 Participants transdermal application of SPM962, 1 time per day	Placebo n=88 Participants transdermal application of placebo, 1 time per day
UPDRS Part 4 Sum Score Week 2	0.19 Scores on a scale Standard Deviation 0.45	0.09 Scores on a scale Standard Deviation 0.33
UPDRS Part 4 Sum Score Week 4	0.28 Scores on a scale Standard Deviation 0.79	0.08 Scores on a scale Standard Deviation 0.38
UPDRS Part 4 Sum Score Week 6	0.18 Scores on a scale Standard Deviation 0.54	0.03 Scores on a scale Standard Deviation 0.39
UPDRS Part 4 Sum Score Week 8	0.20 Scores on a scale Standard Deviation 0.61	0.09 Scores on a scale Standard Deviation 0.42
UPDRS Part 4 Sum Score Week 10	0.19 Scores on a scale Standard Deviation 0.62	0.03 Scores on a scale Standard Deviation 0.44
UPDRS Part 4 Sum Score Week 12	0.18 Scores on a scale Standard Deviation 0.64	0.05 Scores on a scale Standard Deviation 0.48
UPDRS Part 4 Sum Score End of maintenance period	0.18 Scores on a scale Standard Deviation 0.64	0.03 Scores on a scale Standard Deviation 0.47

SECONDARY outcome

Timeframe: Baseline, every two weeks

Population: FAS, LOCF

Mean change (LOCF) from baseline to the end of maintenance period in total of each sum score of UPDRS Part 1, 2, 3 and 4.

UPDRS sub-scale Part 1, 2, 3, and 4 assess 4, 13, 14, and 11 items respectively. 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	SPM962 n=88 Participants transdermal application of SPM962, 1 time per day	Placebo n=88 Participants transdermal application of placebo, 1 time per day
Total of Each Sum Score of UPDRS Part 1, 2, 3, and 4 Week 2	-3.3 Scores on a scale Standard Deviation 5.9	-2.1 Scores on a scale Standard Deviation 4.6
Total of Each Sum Score of UPDRS Part 1, 2, 3, and 4 Week 4	-5.4 Scores on a scale Standard Deviation 7.1	-3.8 Scores on a scale Standard Deviation 5.8
Total of Each Sum Score of UPDRS Part 1, 2, 3, and 4 Week 6	-7.2 Scores on a scale Standard Deviation 8.7	-4.7 Scores on a scale Standard Deviation 6.7
Total of Each Sum Score of UPDRS Part 1, 2, 3, and 4 Week 8	-7.7 Scores on a scale Standard Deviation 9.4	-4.6 Scores on a scale Standard Deviation 7.6
Total of Each Sum Score of UPDRS Part 1, 2, 3, and 4 Week 10	-8.1 Scores on a scale Standard Deviation 9.6	-4.7 Scores on a scale Standard Deviation 7.7
Total of Each Sum Score of UPDRS Part 1, 2, 3, and 4 Week 12	-8.5 Scores on a scale Standard Deviation 9.9	-4.1 Scores on a scale Standard Deviation 8.5
Total of Each Sum Score of UPDRS Part 1, 2, 3, and 4 End of maintenance period	-8.5 Scores on a scale Standard Deviation 9.9	-4.1 Scores on a scale Standard Deviation 8.5

SECONDARY outcome

Timeframe: Baseline, end of maintenance period

Population: FAS, LOCF

Mean change (LOCF) from baseline in the Modified Hoehn and Yahr Severity of Illness at the end of maintenance period. The Modified Hoehn and Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease without impairment of balance; 2.5, Mild bilateral disease with recovery on pull test; 3, Mild to moderate bilateral disease, some postural instability, physically independent 4, Severe disability, still able to walk or stand unassisted; and 5, Wheelchair bound or bedridden unless aided.

Outcome measures

Measure	SPM962 n=86 Participants transdermal application of SPM962, 1 time per day	Placebo n=88 Participants transdermal application of placebo, 1 time per day
The Modified Hoehn and Yahr Stage Increased	8.1 Percentage of participants	9.1 Percentage of participants
The Modified Hoehn and Yahr Stage Not changed	66.3 Percentage of participants	71.6 Percentage of participants
The Modified Hoehn and Yahr Stage Decreased	25.6 Percentage of participants	19.3 Percentage of participants

Adverse Events

SPM962

Serious events: 2 serious events

Other events: 73 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Measure	SPM962 n=90 participants at risk transdermal application of SPM962, 1 time per day	Placebo n=90 participants at risk transdermal application of placebo, 1 time per day
Vascular disorders Cerebral Infarction	1.1% 1/90 • Number of events 1 • 14 weeks	0.00% 0/90 • 14 weeks
Nervous system disorders Myelopathy	1.1% 1/90 • Number of events 1 • 14 weeks	0.00% 0/90 • 14 weeks

Other adverse events

Measure	SPM962 n=90 participants at risk transdermal application of SPM962, 1 time per day	Placebo n=90 participants at risk transdermal application of placebo, 1 time per day
Metabolism and nutrition disorders Anorexia	3.3% 3/90 • Number of events 3 • 14 weeks	0.00% 0/90 • 14 weeks
General disorders Application Site Reaction	46.7% 42/90 • Number of events 43 • 14 weeks	22.2% 20/90 • Number of events 20 • 14 weeks
Musculoskeletal and connective tissue disorders Back Pain	3.3% 3/90 • Number of events 3 • 14 weeks	1.1% 1/90 • Number of events 1 • 14 weeks
Investigations Blood Creatine Phosphokinase Increased	4.4% 4/90 • Number of events 4 • 14 weeks	2.2% 2/90 • Number of events 2 • 14 weeks
Gastrointestinal disorders Constipation	13.3% 12/90 • Number of events 12 • 14 weeks	5.6% 5/90 • Number of events 5 • 14 weeks
Injury, poisoning and procedural complications Contusion	1.1% 1/90 • Number of events 1 • 14 weeks	7.8% 7/90 • Number of events 8 • 14 weeks
Gastrointestinal disorders Diarrhoea	3.3% 3/90 • Number of events 3 • 14 weeks	3.3% 3/90 • Number of events 3 • 14 weeks
Nervous system disorders Dizziness	0.00% 0/90 • 14 weeks	4.4% 4/90 • Number of events 5 • 14 weeks
Gastrointestinal disorders Gastritis	3.3% 3/90 • Number of events 3 • 14 weeks	0.00% 0/90 • 14 weeks
Psychiatric disorders Hallucination	4.4% 4/90 • Number of events 5 • 14 weeks	0.00% 0/90 • 14 weeks
Psychiatric disorders Hallucination Visual	3.3% 3/90 • Number of events 3 • 14 weeks	0.00% 0/90 • 14 weeks
Psychiatric disorders Insomnia	6.7% 6/90 • Number of events 6 • 14 weeks	2.2% 2/90 • Number of events 2 • 14 weeks
Infections and infestations Nasopharyngitis	12.2% 11/90 • Number of events 11 • 14 weeks	16.7% 15/90 • Number of events 15 • 14 weeks
Gastrointestinal disorders Nausea	23.3% 21/90 • Number of events 29 • 14 weeks	5.6% 5/90 • Number of events 5 • 14 weeks
Skin and subcutaneous tissue disorders Rash	0.00% 0/90 • 14 weeks	6.7% 6/90 • Number of events 7 • 14 weeks
Psychiatric disorders Somnolence	14.4% 13/90 • Number of events 13 • 14 weeks	4.4% 4/90 • Number of events 4 • 14 weeks
Gastrointestinal disorders Vomiting	15.6% 14/90 • Number of events 22 • 14 weeks	1.1% 1/90 • Number of events 1 • 14 weeks

Additional Information

Director of Clinical Research and Development

Otsuka Pharmaceutical Co., Ltd.

Phone: +81-3-6131-7366

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place