Trial Outcomes & Findings for A Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients (NCT NCT01628848)
NCT ID: NCT01628848
Last Updated: 2014-03-19
Results Overview
Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 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
PHASE2
174 participants
baseline, 12 weeks after dosing
2014-03-19
Participant Flow
Participant milestones
| Measure |
SPM 962
SPM 962 transdermal patch
|
Placebo
Placebo transdermal patch
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
87
|
|
Overall Study
COMPLETED
|
75
|
73
|
|
Overall Study
NOT COMPLETED
|
12
|
14
|
Reasons for withdrawal
| Measure |
SPM 962
SPM 962 transdermal patch
|
Placebo
Placebo transdermal patch
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
7
|
|
Overall Study
Lack of Efficacy
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Physician Decision
|
3
|
1
|
Baseline Characteristics
A Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients
Baseline characteristics by cohort
| Measure |
SPM 962
n=86 Participants
SPM 962 transdermal patch
|
Placebo
n=86 Participants
Placebo transdermal patch
|
Total
n=172 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
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
62 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Age, Continuous
|
67.0 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
66.8 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
66.9 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
87 participants
n=5 Participants
|
87 participants
n=7 Participants
|
174 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 12 weeks after dosingPopulation: Full analysis set (FAS), last observation carried forward (LOCF)
Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 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=86 Participants
SPM 962 transdermal patch
|
Placebo
n=86 Participants
Placebo transdermal patch
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score
|
-10.1 Scores on a scale
Standard Deviation 9.0
|
-4.4 Scores on a scale
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: baseline, 12 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 12 weeks after dosing. Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average score of on state and off state) at 12 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 |
SPM 962
n=86 Participants
SPM 962 transdermal patch
|
Placebo
n=86 Participants
Placebo transdermal patch
|
|---|---|---|
|
UPDRS Part 2 Sum Score (Average Score of on State and Off State)
|
-3.8 Scores on a scale
Standard Deviation 3.6
|
-1.6 Scores on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: baseline, 12 weeks after dosingPopulation: FAS subjects with measurable off time data at baseline, LOCF
Mean change (LOCF) from baseline in off time at 12 weeks after dosing.
Outcome measures
| Measure |
SPM 962
n=54 Participants
SPM 962 transdermal patch
|
Placebo
n=56 Participants
Placebo transdermal patch
|
|---|---|---|
|
Off Time
|
-2.1 Hours
Standard Deviation 3.1
|
-0.7 Hours
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks after dosingPopulation: FAS, LOCF
Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 3 sum score at 12 weeks after dosing.
Outcome measures
| Measure |
SPM 962
n=86 Participants
SPM 962 transdermal patch
|
Placebo
n=86 Participants
Placebo transdermal patch
|
|---|---|---|
|
Effective Rate in UPDRS Part 3 Sum Score
Subjects with ≥30% decrease
|
64.0 Percentage of participants
Interval 53.8 to 74.1
|
29.1 Percentage of participants
Interval 19.5 to 38.7
|
|
Effective Rate in UPDRS Part 3 Sum Score
Subjects with ≥20% decrease
|
73.3 Percentage of participants
Interval 63.9 to 82.6
|
43.0 Percentage of participants
Interval 32.6 to 53.5
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks after dosingPopulation: FAS, LOCF
Mean change (LOCF) from baseline in UPDRS Part 1 sum score at 12 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 |
SPM 962
n=86 Participants
SPM 962 transdermal patch
|
Placebo
n=86 Participants
Placebo transdermal patch
|
|---|---|---|
|
UPDRS Part 1 Sum Score
|
-0.15 Scores on a scale
Standard Deviation 1.34
|
-0.12 Scores on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks after dosing.Population: 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 12 weeks after dosing.
Outcome measures
| Measure |
SPM 962
n=54 Participants
SPM 962 transdermal patch
|
Placebo
n=56 Participants
Placebo transdermal patch
|
|---|---|---|
|
Effective Rate in Off Time
Subjects with ≥20% decrease
|
63.0 Percentage of participants
Interval 50.1 to 75.8
|
46.4 Percentage of participants
Interval 33.4 to 59.5
|
|
Effective Rate in Off Time
Subjects with ≥30% decrease
|
51.9 Percentage of participants
Interval 38.5 to 65.2
|
37.5 Percentage of participants
Interval 24.8 to 50.2
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks after dosingPopulation: FAS, LOCF
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (on state) at 12 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 |
SPM 962
n=86 Participants
SPM 962 transdermal patch
|
Placebo
n=86 Participants
Placebo transdermal patch
|
|---|---|---|
|
UPDRS Part 2 Sum Score (on State)
|
-3.0 Scores on a scale
Standard Deviation 3.7
|
-1.2 Scores on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks after dosingPopulation: FAS, LOCF
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (off state) at 12 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 |
SPM 962
n=55 Participants
SPM 962 transdermal patch
|
Placebo
n=59 Participants
Placebo transdermal patch
|
|---|---|---|
|
UPDRS Part 2 Sum Score (Off State)
|
-4.6 Scores on a scale
Standard Deviation 4.5
|
-1.9 Scores on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks after dosingPopulation: FAS, LOCF
Mean change (LOCF) from baseline in UPDRS Part 4 sum score at 12 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 |
SPM 962
n=86 Participants
SPM 962 transdermal patch
|
Placebo
n=85 Participants
Placebo transdermal patch
|
|---|---|---|
|
UPDRS Part 4 Sum Score
|
-0.40 Scores on a scale
Standard Deviation 1.73
|
-0.22 Scores on a scale
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks after dosingPopulation: FAS, LOCF
Mean change (LOCF) from baseline in total of UPDRS Part 2 sum score (average score of on state and off state), and UPDRS Part 3 sum score at 12 weeks after dosing. UPDRS sub-scale 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 |
SPM 962
n=86 Participants
SPM 962 transdermal patch
|
Placebo
n=86 Participants
Placebo transdermal patch
|
|---|---|---|
|
Total of UPDRS Part 2 Sum Score (Average Score of on State and Off State) and UPDRS Part 3 Sum Score
|
-14.0 Scores on a scale
Standard Deviation 11.4
|
-6.0 Scores on a scale
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks after dosingPopulation: FAS, LOCF
Mean change (LOCF) from baseline in total of UPDRS Part 1 sum score, UPDRS Part 2 sum score (average score of on state and off state), UPDRS Part 3 sum score, and UPDRS Part 4 sum score at 12 weeks after dosing. 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 |
SPM 962
n=86 Participants
SPM 962 transdermal patch
|
Placebo
n=86 Participants
Placebo transdermal patch
|
|---|---|---|
|
Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average Score of on State and Off State), UPDRS Part 3 Sum Score, and UPDRS Part 4 Sum Score.
|
-14.6 Scores on a scale
Standard Deviation 11.9
|
-6.4 Scores on a scale
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks after dosingPopulation: FAS, LOCF
Mean change (LOCF) from baseline in the Modified Hoehn \& Yahr Severity of Illness at 12 weeks after dosing. The Modified Hoehn \& 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 |
SPM 962
n=86 Participants
SPM 962 transdermal patch
|
Placebo
n=86 Participants
Placebo transdermal patch
|
|---|---|---|
|
The Modified Hoehn & Yahr Severity of Illness
Increased
|
1.2 Percentage of participants
|
4.7 Percentage of participants
|
|
The Modified Hoehn & Yahr Severity of Illness
Not changed
|
61.6 Percentage of participants
|
80.0 Percentage of participants
|
|
The Modified Hoehn & Yahr Severity of Illness
Decreased
|
37.2 Percentage of participants
|
15.3 Percentage of participants
|
Adverse Events
SPM 962
Placebo
Serious adverse events
| Measure |
SPM 962
n=87 participants at risk
SPM 962 transdermal patch
|
Placebo
n=87 participants at risk
Placebo transdermal patch
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
1/87 • Number of events 1 • 14 weeks
|
0.00%
0/87 • 14 weeks
|
|
Gastrointestinal disorders
Hernia Inguinal
|
0.00%
0/87 • 14 weeks
|
1.1%
1/87 • Number of events 1 • 14 weeks
|
|
General disorders
Malaise
|
1.1%
1/87 • Number of events 1 • 14 weeks
|
0.00%
0/87 • 14 weeks
|
|
Infections and infestations
Arthritis Bacterial
|
0.00%
0/87 • 14 weeks
|
1.1%
1/87 • Number of events 1 • 14 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/87 • 14 weeks
|
1.1%
1/87 • Number of events 1 • 14 weeks
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
1.1%
1/87 • Number of events 1 • 14 weeks
|
0.00%
0/87 • 14 weeks
|
|
Nervous system disorders
Consciousness Loss
|
0.00%
0/87 • 14 weeks
|
1.1%
1/87 • Number of events 1 • 14 weeks
|
|
Nervous system disorders
Neuroleptic Malignant
|
1.1%
1/87 • Number of events 1 • 14 weeks
|
0.00%
0/87 • 14 weeks
|
|
Psychiatric disorders
Delusion
|
1.1%
1/87 • Number of events 1 • 14 weeks
|
0.00%
0/87 • 14 weeks
|
|
Psychiatric disorders
Hallucination, Auditory
|
1.1%
1/87 • Number of events 1 • 14 weeks
|
0.00%
0/87 • 14 weeks
|
Other adverse events
| Measure |
SPM 962
n=87 participants at risk
SPM 962 transdermal patch
|
Placebo
n=87 participants at risk
Placebo transdermal patch
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.4%
3/87 • Number of events 3 • 14 weeks
|
1.1%
1/87 • Number of events 1 • 14 weeks
|
|
Gastrointestinal disorders
Nausea
|
19.5%
17/87 • Number of events 17 • 14 weeks
|
5.7%
5/87 • Number of events 8 • 14 weeks
|
|
Gastrointestinal disorders
Constipation
|
10.3%
9/87 • Number of events 9 • 14 weeks
|
1.1%
1/87 • Number of events 1 • 14 weeks
|
|
Gastrointestinal disorders
Vomiting
|
10.3%
9/87 • Number of events 10 • 14 weeks
|
1.1%
1/87 • Number of events 1 • 14 weeks
|
|
Gastrointestinal disorders
Gastric Ulcer
|
4.6%
4/87 • Number of events 4 • 14 weeks
|
0.00%
0/87 • 14 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
3/87 • Number of events 4 • 14 weeks
|
1.1%
1/87 • Number of events 1 • 14 weeks
|
|
General disorders
Application Site Reaction
|
50.6%
44/87 • Number of events 46 • 14 weeks
|
18.4%
16/87 • Number of events 21 • 14 weeks
|
|
General disorders
Application Site Erythema
|
9.2%
8/87 • Number of events 14 • 14 weeks
|
4.6%
4/87 • Number of events 5 • 14 weeks
|
|
General disorders
Application Site Pruritus
|
5.7%
5/87 • Number of events 5 • 14 weeks
|
4.6%
4/87 • Number of events 4 • 14 weeks
|
|
General disorders
Feeling Abnormal
|
3.4%
3/87 • Number of events 3 • 14 weeks
|
1.1%
1/87 • Number of events 1 • 14 weeks
|
|
Infections and infestations
Nasopharyngitis
|
20.7%
18/87 • Number of events 20 • 14 weeks
|
14.9%
13/87 • Number of events 19 • 14 weeks
|
|
Infections and infestations
Cystitis
|
2.3%
2/87 • Number of events 2 • 14 weeks
|
3.4%
3/87 • Number of events 3 • 14 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
6.9%
6/87 • Number of events 6 • 14 weeks
|
8.0%
7/87 • Number of events 7 • 14 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
5.7%
5/87 • Number of events 5 • 14 weeks
|
3.4%
3/87 • Number of events 4 • 14 weeks
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.1%
1/87 • Number of events 1 • 14 weeks
|
4.6%
4/87 • Number of events 4 • 14 weeks
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
6.9%
6/87 • Number of events 6 • 14 weeks
|
3.4%
3/87 • Number of events 3 • 14 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
6.9%
6/87 • Number of events 6 • 14 weeks
|
0.00%
0/87 • 14 weeks
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
4.6%
4/87 • Number of events 6 • 14 weeks
|
1.1%
1/87 • Number of events 1 • 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.4%
3/87 • Number of events 3 • 14 weeks
|
4.6%
4/87 • Number of events 4 • 14 weeks
|
|
Nervous system disorders
Dyskinesia
|
13.8%
12/87 • Number of events 13 • 14 weeks
|
8.0%
7/87 • Number of events 7 • 14 weeks
|
|
Nervous system disorders
Dizziness
|
8.0%
7/87 • Number of events 8 • 14 weeks
|
2.3%
2/87 • Number of events 2 • 14 weeks
|
|
Nervous system disorders
Dizziness Postural
|
8.0%
7/87 • Number of events 7 • 14 weeks
|
1.1%
1/87 • Number of events 2 • 14 weeks
|
|
Nervous system disorders
Headache
|
5.7%
5/87 • Number of events 5 • 14 weeks
|
2.3%
2/87 • Number of events 2 • 14 weeks
|
|
Psychiatric disorders
Somnolence
|
13.8%
12/87 • Number of events 12 • 14 weeks
|
1.1%
1/87 • Number of events 1 • 14 weeks
|
|
Psychiatric disorders
Hallucination Visual
|
9.2%
8/87 • Number of events 10 • 14 weeks
|
2.3%
2/87 • Number of events 2 • 14 weeks
|
|
Psychiatric disorders
Hallucination
|
3.4%
3/87 • Number of events 3 • 14 weeks
|
3.4%
3/87 • Number of events 3 • 14 weeks
|
|
Psychiatric disorders
Insomnia
|
3.4%
3/87 • Number of events 3 • 14 weeks
|
3.4%
3/87 • Number of events 3 • 14 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
1.1%
1/87 • Number of events 1 • 14 weeks
|
3.4%
3/87 • Number of events 3 • 14 weeks
|
Additional Information
Director of Clinical Research and Development
Otsuka Pharmaceutical Co., Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place