Trial Outcomes & Findings for A Long-Term Extension Trial From of SPM 962 in Advanced Parkinson's Disease Patients (NCT NCT01631825)
NCT ID: NCT01631825
Last Updated: 2014-03-19
Results Overview
The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of AEs, vital signs, and laboratory parameters. AEs of special interest (1-3) are defined as below: 1. sudden onset of sleep 2. obsessive-compulsive disorder or impulse-control disorder 3. hallucination, delusion Application site reaction is scored as -, ±, +, ++, +++, or ++++. More + indicates a greater severity of symptoms. The worst score obtained throughout the evaluation period was to be assessed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
321 participants
Primary outcome timeframe
Up to 55 weeks after dosing
Results posted on
2014-03-19
Participant Flow
Participant milestones
| Measure |
SPM 962
SPM 962 transdermal patch
|
|---|---|
|
Overall Study
STARTED
|
321
|
|
Overall Study
COMPLETED
|
256
|
|
Overall Study
NOT COMPLETED
|
65
|
Reasons for withdrawal
| Measure |
SPM 962
SPM 962 transdermal patch
|
|---|---|
|
Overall Study
Adverse Event
|
42
|
|
Overall Study
Lack of Efficacy
|
7
|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Protocol Violation
|
4
|
|
Overall Study
Discontinuation criteria
|
1
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
A Long-Term Extension Trial From of SPM 962 in Advanced Parkinson's Disease Patients
Baseline characteristics by cohort
| Measure |
SPM 962
n=321 Participants
SPM 962 transdermal patch
|
|---|---|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
115 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
206 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
185 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
321 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 55 weeks after dosingPopulation: Safety set (SS)
The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of AEs, vital signs, and laboratory parameters. AEs of special interest (1-3) are defined as below: 1. sudden onset of sleep 2. obsessive-compulsive disorder or impulse-control disorder 3. hallucination, delusion Application site reaction is scored as -, ±, +, ++, +++, or ++++. More + indicates a greater severity of symptoms. The worst score obtained throughout the evaluation period was to be assessed.
Outcome measures
| Measure |
SPM 962
n=321 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
|---|---|
|
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
Any AEs
|
311 participants
|
|
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
Treatment-related AEs
|
269 participants
|
|
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
SAEs
|
34 participants
|
|
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
Treatment-related SAEs
|
6 participants
|
|
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
Severe AEs
|
16 participants
|
|
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
Discontinuation due to AEs
|
47 participants
|
|
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
Death
|
1 participants
|
|
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
AEs of special interest 1
|
7 participants
|
|
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
AEs of special interest 2
|
4 participants
|
|
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
AEs of special interest 3
|
54 participants
|
|
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
Valvular disease of the heart
|
0 participants
|
|
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
Sitting systolic blood pressure, ≤ 100 mmHg
|
9 participants
|
|
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
QTcB ≥ 500 ms
|
5 participants
|
|
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
QTcF ≥ 500 ms
|
2 participants
|
|
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
Application site reaction ≥ +++
|
14 participants
|
|
Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters
Weight decrease reported as AE
|
8 participants
|
SECONDARY outcome
Timeframe: Baseline, Up to 54 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). 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=316 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score
Week 12
|
-8.3 Scores on a scale
Standard Deviation 7.1
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score
Week 24
|
-8.0 Scores on a scale
Standard Deviation 7.6
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score
Week 52
|
-7.5 Scores on a scale
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: Baseline, up to 54 weeks after dosingPopulation: FAS, LOCF
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average of on state and off state). 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=316 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
|---|---|
|
UPDRS Part 2 Sum Score (Average of on State and Off State)
Week 12
|
-2.6 Scores on a scale
Standard Deviation 3.0
|
|
UPDRS Part 2 Sum Score (Average of on State and Off State)
Week 24
|
-2.5 Scores on a scale
Standard Deviation 3.4
|
|
UPDRS Part 2 Sum Score (Average of on State and Off State)
Week 52
|
-1.9 Scores on a scale
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Baseline, up to 54 weeks after dosingPopulation: FAS subjects with measurable off time at baseline, LOCF
Mean number of hours in "off state" during a 24-hour period.
Outcome measures
| Measure |
SPM 962
n=213 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
|---|---|
|
Absolute Time Spent "Off"
Week 12
|
-2.5 Hours
Standard Deviation 2.5
|
|
Absolute Time Spent "Off"
Week 24
|
-2.5 Hours
Standard Deviation 2.7
|
|
Absolute Time Spent "Off"
Week 52
|
-2.0 Hours
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Baseline, up to 54 weeks after dosingPopulation: FAS, LOCF
Mean change (LOCF) from baseline in UPDRS Part 1 sum score. 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=317 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
|---|---|
|
UPDRS Part 1 Sum Score
Week 12
|
-0.33 Scores on a scale
Standard Deviation 1.07
|
|
UPDRS Part 1 Sum Score
Week 24
|
-0.25 Scores on a scale
Standard Deviation 1.17
|
|
UPDRS Part 1 Sum Score
Week 52
|
-0.15 Scores on a scale
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: Baseline, up to 54 weeks after dosingPopulation: FAS, LOCF
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (on state). A decrease in the scores means improvement.
Outcome measures
| Measure |
SPM 962
n=317 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
|---|---|
|
UPDRS Part 2 Sum Score (On State)
Week 12
|
-1.9 Scores on a scale
Standard Deviation 2.8
|
|
UPDRS Part 2 Sum Score (On State)
Week 24
|
-1.7 Scores on a scale
Standard Deviation 3.0
|
|
UPDRS Part 2 Sum Score (On State)
Week 52
|
-1.3 Scores on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline, up to 54 weeks after dosingPopulation: FAS, LOCF
Mean change (LOCF) from baseline in UPDRS Part 2 sum score (off state). A decrease in the scores means improvement.
Outcome measures
| Measure |
SPM 962
n=212 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
|---|---|
|
UPDRS Part 2 Sum Score (Off State)
Week 12
|
-3.7 Scores on a scale
Standard Deviation 4.3
|
|
UPDRS Part 2 Sum Score (Off State)
Week 24
|
-3.8 Scores on a scale
Standard Deviation 4.8
|
|
UPDRS Part 2 Sum Score (Off State)
Week 52
|
-2.5 Scores on a scale
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: Baseline, up to 54 weeks after dosingPopulation: FAS, LOCF
Mean change (LOCF) from baseline in UPDRS Part 4 sum score. 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=317 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
|---|---|
|
UPDRS Part 4 Sum Score
Week 12
|
-0.24 Scores on a scale
Standard Deviation 1.29
|
|
UPDRS Part 4 Sum Score
Week 24
|
-0.28 Scores on a scale
Standard Deviation 1.32
|
|
UPDRS Part 4 Sum Score
Week 52
|
-0.13 Scores on a scale
Standard Deviation 1.42
|
SECONDARY outcome
Timeframe: Baseline, up to 54 weeks after dosingPopulation: FAS, LOCF
Mean change (LOCF) from baseline in total of UPDRS Part 1 sum score, UPDRS Part 2 sum score (average of on state and off state), UPDRS Part 3 sum score (on state), and UPDRS Part 4 sum score. A decrease in the scores means improvement.
Outcome measures
| Measure |
SPM 962
n=315 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
|---|---|
|
Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average of on State and Off State), UPDRS Part 3 Sum Score (on State), and UPDRS Part 4 Sum Score
Week 12
|
-11.4 Scores on a scale
Standard Deviation 9.7
|
|
Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average of on State and Off State), UPDRS Part 3 Sum Score (on State), and UPDRS Part 4 Sum Score
Week 24
|
-11.1 Scores on a scale
Standard Deviation 10.5
|
|
Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average of on State and Off State), UPDRS Part 3 Sum Score (on State), and UPDRS Part 4 Sum Score
Week 52
|
-9.7 Scores on a scale
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: Baseline, up to 54 weeks after dosing.Population: FAS, LOCF
Change (LOCF) from baseline in the Modified Hoehn \& Yahr Severity of Illness. 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. The data at week 52 is shown.
Outcome measures
| Measure |
SPM 962
n=316 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
|---|---|
|
The Modified Hoehn & Yahr Severity of Illness
Increased
|
7.3 Percentage of participants
|
|
The Modified Hoehn & Yahr Severity of Illness
Not changed
|
62.5 Percentage of participants
|
|
The Modified Hoehn & Yahr Severity of Illness
Decreased
|
30.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, up to 54 weeks after dosing.Population: FAS, LOCF
The percentage of subjects with elevated scores for each item of UPDRS Part 1. The data at week 52 is shown.
Outcome measures
| Measure |
SPM 962
n=317 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
|---|---|
|
Each Item of UPDRS Part 1
Intellectual impairment
|
2.8 Percentage of Participants
|
|
Each Item of UPDRS Part 1
Thought disorder
|
9.5 Percentage of Participants
|
|
Each Item of UPDRS Part 1
Depression
|
5.0 Percentage of Participants
|
|
Each Item of UPDRS Part 1
Motivation/Initiative
|
4.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, up to 54 weeks after dosing.Population: FAS, LOCF
The percentage of subjects with elevated scores for each item of UPDRS Part 2 (on state). The data at week 52 is shown.
Outcome measures
| Measure |
SPM 962
n=317 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
|---|---|
|
Each Item of UPDRS Part 2 (on State)
Speech
|
4.7 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (on State)
Salivation
|
11.0 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (on State)
Swallowing
|
6.0 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (on State)
Handwriting
|
7.6 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (on State)
Cutting Food and Handling Utensils
|
6.9 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (on State)
Dressing
|
6.6 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (on State)
Hygiene
|
5.0 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (on State)
Turning in Bed / Adjusting Bed Clothes
|
7.9 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (on State)
Falling - Unrelated to Freezing
|
8.2 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (on State)
Freezing When Walking
|
6.6 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (on State)
Walking
|
8.5 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (on State)
Tremor
|
4.4 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (on State)
Sensory Complaints Related to Parkinsonism
|
3.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, up to 54 weeks after dosing.Population: FAS, LOCF
The percentage of subjects with elevated scores for each item of UPDRS Part 2 (off state). The data at week 52 is shown.
Outcome measures
| Measure |
SPM 962
n=190 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
|---|---|
|
Each Item of UPDRS Part 2 (Off State)
Speech
|
5.8 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Off State)
Salivation
|
10.5 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Off State)
Swallowing
|
6.3 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Off State)
Handwriting
|
11.6 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Off State)
Cutting Food and Handling Utensils
|
11.6 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Off State)
Dressing
|
9.5 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Off State)
Hygiene
|
11.6 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Off State)
Turning in Bed / Adjusting Bed Clothes
|
10.5 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Off State)
Falling - Unrelated to Freezing
|
9.5 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Off State)
Freezing When Walking
|
17.9 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Off State)
Walking
|
13.2 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Off State)
Tremor
|
4.2 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Off State)
Sensory Complaints Related to Parkinsonism
|
5.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, up to 54 weeks after dosing.Population: FAS, LOCF
The percentage of subjects with elevated scores for each item of UPDRS Part 2 (average of on state and off state). The data at week 52 is shown.
Outcome measures
| Measure |
SPM 962
n=317 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
|---|---|
|
Each Item of UPDRS Part 2 (Average of on State and Off State)
Speech
|
6.7 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Average of on State and Off State)
Salivation
|
13.7 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Average of on State and Off State)
Swallowing
|
7.6 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Average of on State and Off State)
Handwriting
|
12.1 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Average of on State and Off State)
Dressing
|
9.2 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Average of on State and Off State)
Hygiene
|
10.2 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Average of on State and Off State)
Turning in Bed / Adjusting Bed Clothes
|
10.5 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Average of on State and Off State)
Cutting Food and Handling Utensils
|
11.1 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Average of on State and Off State)
Falling - Unrelated to Freezing
|
9.9 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Average of on State and Off State)
Freezing When Walking
|
14.6 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Average of on State and Off State)
Walking
|
12.7 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Average of on State and Off State)
Tremor
|
5.7 Percentage of Participants
|
|
Each Item of UPDRS Part 2 (Average of on State and Off State)
Sensory Complaints Related to Parkinsonism
|
5.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, up to 54 weeks after dosingPopulation: FAS, LOCF
Mean change (LOCF) from baseline in total of UPDRS Part 2 sum score (average of on state and off state) and UPDRS Part 3 sum score (on state). A decrease in the scores means improvement.
Outcome measures
| Measure |
SPM 962
n=315 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
|---|---|
|
Total of UPDRS Part 2 Sum Score (Average of on State and Off State) and UPDRS Part 3 Sum Score (on State)
Week 12
|
-10.9 Scores on a scale
Standard Deviation 9.2
|
|
Total of UPDRS Part 2 Sum Score (Average of on State and Off State) and UPDRS Part 3 Sum Score (on State)
Week 24
|
-10.5 Scores on a scale
Standard Deviation 9.9
|
|
Total of UPDRS Part 2 Sum Score (Average of on State and Off State) and UPDRS Part 3 Sum Score (on State)
Week 52
|
-9.4 Scores on a scale
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: Baseline, up to 54 weeks after dosing.Population: FAS, LOCF
The percentage of subjects with elevated scores for each item of UPDRS Part 3 (on state). The data at week 52 is shown.
Outcome measures
| Measure |
SPM 962
n=317 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
|---|---|
|
Each Item of UPDRS Part 3 (on State)
Posture Erect
|
11.4 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Speech
|
6.3 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Facial Expression
|
5.4 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Tremor at Rest (Face, lips, chin)
|
0.6 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Tremor at Rest (Left hand)
|
1.6 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Tremor at Rest (Right hand)
|
1.6 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Tremor at Rest (Left foot)
|
2.2 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Tremor at Rest (Right foot)
|
1.6 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Action or Postural Tremor of Hands (Left hand)
|
5.4 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Action or Postural Tremor of Hands (Right hand)
|
6.6 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Rigidity (Neck)
|
5.0 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Rigidity (Left upper extremity)
|
2.8 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Rigidity (Right upper extremity)
|
2.8 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Rigidity (Left lower extremity)
|
5.0 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Rigidity (Right lower extremity)
|
4.1 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Finger Taps (Left)
|
5.1 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Finger Taps (Right)
|
5.7 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Hand Movements (Left)
|
7.6 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Hand Movements (Right)
|
6.6 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Rapid Alternating Movements of Hands (Left)
|
7.3 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Rapid Alternating Movements of Hands (Right)
|
6.9 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Leg Agility (Left)
|
6.6 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Leg Agility (Right)
|
7.3 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Arising From Chair
|
9.6 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Gait
|
9.6 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Postural Stability
|
8.9 Percentage of Participants
|
|
Each Item of UPDRS Part 3 (on State)
Body Bradykinesia / Hypokinesia
|
7.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, up to 54 weeks after dosing.Population: FAS, LOCF
The percentage of subjects with elevated scores for each item of UPDRS Part 4. The data at week 52 is shown.
Outcome measures
| Measure |
SPM 962
n=317 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
|---|---|
|
Each Item of UPDRS Part 4
Duration
|
15.1 Percentage of Participants
|
|
Each Item of UPDRS Part 4
Disability
|
5.7 Percentage of Participants
|
|
Each Item of UPDRS Part 4
Painful Dyskinesias
|
0.6 Percentage of Participants
|
|
Each Item of UPDRS Part 4
Presence of Early Morning Dystonia
|
2.5 Percentage of Participants
|
|
Each Item of UPDRS Part 4
Are "off" periods predictable?
|
3.2 Percentage of Participants
|
|
Each Item of UPDRS Part 4
Are "off" periods unpredictable?
|
1.6 Percentage of Participants
|
|
Each Item of UPDRS Part 4
Do "off" periods come on suddenly?
|
1.3 Percentage of Participants
|
|
Each Item of UPDRS Part 4
Proportion of "off" in waking day
|
5.7 Percentage of Participants
|
|
Each Item of UPDRS Part 4
Patients with anorexia, nausea, or vomiting
|
5.0 Percentage of Participants
|
|
Each Item of UPDRS Part 4
Patients with any sleep disturbances
|
10.7 Percentage of Participants
|
|
Each Item of UPDRS Part 4
Patient with symptomatic orthostasis
|
1.9 Percentage of Participants
|
Adverse Events
SPM 962
Serious events: 34 serious events
Other events: 290 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SPM 962
n=321 participants at risk
SPM 962 transdermal patch
|
|---|---|
|
Gastrointestinal disorders
Colonic Polyp
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Gastrointestinal disorders
Gastric Ulcer Bleeding
|
0.93%
3/321 • Number of events 3 • 54 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Gastrointestinal disorders
Hernia Inguinal
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
General disorders
Sudden Death
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Infections and infestations
Herpes Zoster
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Infections and infestations
Osteomyelitis
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Infections and infestations
Pneumonia
|
0.62%
2/321 • Number of events 2 • 54 weeks
|
|
Infections and infestations
Septicaemia
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Injury, poisoning and procedural complications
Haematoma Subdural
|
0.62%
2/321 • Number of events 2 • 54 weeks
|
|
Injury, poisoning and procedural complications
Heat Illness
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Injury, poisoning and procedural complications
Jaw Fracture
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Injury, poisoning and procedural complications
Ulna Fracture
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal Marginal Zone B-Cell Lymphoma (Malt Type)
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large Intestine Carcinoma
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Nervous system disorders
Depressed Level Of Consciousness
|
0.62%
2/321 • Number of events 2 • 54 weeks
|
|
Nervous system disorders
Disease Parkinson's
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Psychiatric disorders
Delirium
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Psychiatric disorders
Hallucination Visual
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
|
Psychiatric disorders
Somnolence
|
0.31%
1/321 • Number of events 1 • 54 weeks
|
Other adverse events
| Measure |
SPM 962
n=321 participants at risk
SPM 962 transdermal patch
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
9.7%
31/321 • Number of events 38 • 54 weeks
|
|
Gastrointestinal disorders
Dental Caries
|
6.2%
20/321 • Number of events 21 • 54 weeks
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
16/321 • Number of events 25 • 54 weeks
|
|
Gastrointestinal disorders
Constipation
|
4.0%
13/321 • Number of events 13 • 54 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
2.5%
8/321 • Number of events 8 • 54 weeks
|
|
General disorders
Application Site Reaction
|
61.7%
198/321 • Number of events 217 • 54 weeks
|
|
General disorders
Application Site Pruritus
|
3.7%
12/321 • Number of events 13 • 54 weeks
|
|
General disorders
Oedema Peripheral
|
3.7%
12/321 • Number of events 12 • 54 weeks
|
|
General disorders
Application Site Erythema
|
3.1%
10/321 • Number of events 10 • 54 weeks
|
|
Infections and infestations
Nasopharyngitis
|
23.7%
76/321 • Number of events 108 • 54 weeks
|
|
Infections and infestations
Cystitis
|
3.4%
11/321 • Number of events 17 • 54 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
7.5%
24/321 • Number of events 27 • 54 weeks
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
8.1%
26/321 • Number of events 27 • 54 weeks
|
|
Investigations
Weight Decreased
|
2.5%
8/321 • Number of events 8 • 54 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.2%
20/321 • Number of events 21 • 54 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
11/321 • Number of events 12 • 54 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
2.5%
8/321 • Number of events 8 • 54 weeks
|
|
Nervous system disorders
Dyskinesia
|
15.6%
50/321 • Number of events 57 • 54 weeks
|
|
Nervous system disorders
Headache
|
2.8%
9/321 • Number of events 14 • 54 weeks
|
|
Nervous system disorders
Posture Abnormal
|
2.5%
8/321 • Number of events 8 • 54 weeks
|
|
Psychiatric disorders
Hallucination Visual
|
10.6%
34/321 • Number of events 47 • 54 weeks
|
|
Psychiatric disorders
Somnolence
|
6.5%
21/321 • Number of events 21 • 54 weeks
|
|
Psychiatric disorders
Hallucination
|
5.0%
16/321 • Number of events 21 • 54 weeks
|
|
Psychiatric disorders
Insomnia
|
2.2%
7/321 • Number of events 8 • 54 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
3.4%
11/321 • Number of events 14 • 54 weeks
|
|
Vascular disorders
Orthostatic Hypotension
|
4.7%
15/321 • Number of events 20 • 54 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