Trial Outcomes & Findings for A Long-Term Extension Trial From Phase II/III of SPM 962 in Early Parkinson's Disease Patients (NCT NCT01628965)
NCT ID: NCT01628965
Last Updated: 2014-03-19
Results Overview
Incidence and severity of adverse events, vital signs, and laboratory parameters up to 54 weeks after dosing. \*decrease in difference between supine and standing systolic blood pressure
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
143 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
|
143
|
|
Overall Study
COMPLETED
|
94
|
|
Overall Study
NOT COMPLETED
|
49
|
Reasons for withdrawal
| Measure |
SPM 962
SPM 962 transdermal patch
|
|---|---|
|
Overall Study
Adverse Event
|
30
|
|
Overall Study
Lack of Efficacy
|
7
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Discontinuation criteria
|
8
|
Baseline Characteristics
A Long-Term Extension Trial From Phase II/III of SPM 962 in Early Parkinson's Disease Patients
Baseline characteristics by cohort
| Measure |
SPM 962
n=143 Participants
SPM 962 transdermal patch
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
58 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
85 Participants
n=99 Participants
|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 8.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=99 Participants
|
|
Region of Enrollment
Japan
|
143 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 55 weeks after dosingPopulation: Safety set (SS)
Incidence and severity of adverse events, vital signs, and laboratory parameters up to 54 weeks after dosing. \*decrease in difference between supine and standing systolic blood pressure
Outcome measures
| Measure |
SPM 962
n=143 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
|---|---|
|
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters
Any AEs
|
140 participants
|
|
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters
Treatment-related AEs
|
122 participants
|
|
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters
SAEs
|
18 participants
|
|
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters
Severe AEs
|
9 participants
|
|
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters
Discontinuation due to AEs
|
30 participants
|
|
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters
Severe laboratory abnormality
|
14 participants
|
|
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters
≥30 mmHg decrease*
|
1 participants
|
|
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters
Treatment-related AE of orthostatic hypotension
|
2 participants
|
|
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters
QTcB ≥500 ms
|
1 participants
|
|
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters
Weight decrease of 5% or more
|
53 participants
|
|
Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters
Weight increase of 5% or more
|
22 participants
|
PRIMARY outcome
Timeframe: Up to 55 weeks after dosingPopulation: SS
Skin irritation score of the application site were evaluated according to the criteria below. The worst score throughout the treatment period was used in the analysis. -: no reaction, ±: mild erythema, +: erythema, ++: erythema and Oedema, +++: erythema and oedema and rash papular, or serous papule, or vesicles, ++++: bullosum
Outcome measures
| Measure |
SPM 962
n=142 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
|---|---|
|
Skin Irritation Score of the Application Site
-
|
20 participants
|
|
Skin Irritation Score of the Application Site
±
|
57 participants
|
|
Skin Irritation Score of the Application Site
+
|
46 participants
|
|
Skin Irritation Score of the Application Site
++
|
12 participants
|
|
Skin Irritation Score of the Application Site
+++
|
6 participants
|
|
Skin Irritation Score of the Application Site
++++
|
1 participants
|
|
Skin Irritation Score of the Application Site
+++>
|
7 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 Total of UPDRS Part 2 sum score and Part 3 sum up to 54 weeks after dosingUPDRS 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 |
SPM 962
n=140 Participants
SPM 962 transdermal patch once a daily up to 36.0 mg/day
|
|---|---|
|
Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score
Week 12
|
-9.9 Scores on a scale
Standard Deviation 8.7
|
|
Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score
Week 24
|
-8.3 Scores on a scale
Standard Deviation 9.5
|
|
Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score
Week 52
|
-6.5 Scores on a scale
Standard Deviation 10.1
|
Adverse Events
SPM 962
Serious events: 24 serious events
Other events: 138 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SPM 962
n=143 participants at risk
SPM 962 transdermal patch
|
|---|---|
|
Ear and labyrinth disorders
Positional Vertigo
|
0.70%
1/143 • Number of events 1 • 54 weeks
|
|
Eye disorders
Cataract
|
0.70%
1/143 • Number of events 1 • 54 weeks
|
|
Gastrointestinal disorders
Gastric Ulcer Bleeding
|
0.70%
1/143 • Number of events 1 • 54 weeks
|
|
General disorders
Pyrexia
|
0.70%
1/143 • Number of events 1 • 54 weeks
|
|
Hepatobiliary disorders
Gallbladder Polyp
|
0.70%
1/143 • Number of events 1 • 54 weeks
|
|
Infections and infestations
Pyelonephritis
|
0.70%
1/143 • Number of events 1 • 54 weeks
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.70%
1/143 • Number of events 1 • 54 weeks
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
1.4%
2/143 • Number of events 2 • 54 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
2/143 • Number of events 3 • 54 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.70%
1/143 • Number of events 1 • 54 weeks
|
|
Metabolism and nutrition disorders
Obesity
|
0.70%
1/143 • Number of events 1 • 54 weeks
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.70%
1/143 • Number of events 1 • 54 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.70%
1/143 • Number of events 1 • 54 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.70%
1/143 • Number of events 1 • 54 weeks
|
|
Nervous system disorders
Altered State Of Consciousness
|
0.70%
1/143 • Number of events 1 • 54 weeks
|
|
Nervous system disorders
Cerebral Infarction
|
0.70%
1/143 • Number of events 1 • 54 weeks
|
|
Nervous system disorders
Disease Parkinson's
|
0.70%
1/143 • Number of events 1 • 54 weeks
|
|
Nervous system disorders
Myoclonus
|
0.70%
1/143 • Number of events 1 • 54 weeks
|
|
Nervous system disorders
Neuroleptic Malignant
|
0.70%
1/143 • Number of events 1 • 54 weeks
|
|
Psychiatric disorders
Delusion
|
0.70%
1/143 • Number of events 1 • 54 weeks
|
|
Renal and urinary disorders
Renal Impairment
|
0.70%
1/143 • Number of events 1 • 54 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.70%
1/143 • Number of events 1 • 54 weeks
|
Other adverse events
| Measure |
SPM 962
n=143 participants at risk
SPM 962 transdermal patch
|
|---|---|
|
Ear and labyrinth disorders
Vertigo
|
3.5%
5/143 • Number of events 6 • 54 weeks
|
|
Gastrointestinal disorders
Nausea
|
32.9%
47/143 • Number of events 57 • 54 weeks
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
22/143 • Number of events 44 • 54 weeks
|
|
Gastrointestinal disorders
Constipation
|
14.7%
21/143 • Number of events 21 • 54 weeks
|
|
General disorders
Application Site Reaction
|
67.1%
96/143 • Number of events 100 • 54 weeks
|
|
General disorders
Oedema Peripheral
|
4.9%
7/143 • Number of events 8 • 54 weeks
|
|
Infections and infestations
Nasopharyngitis
|
18.2%
26/143 • Number of events 29 • 54 weeks
|
|
Infections and infestations
Cystitis
|
3.5%
5/143 • Number of events 5 • 54 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
4.9%
7/143 • Number of events 8 • 54 weeks
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
4.2%
6/143 • Number of events 7 • 54 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.1%
13/143 • Number of events 13 • 54 weeks
|
|
Nervous system disorders
Dizziness
|
5.6%
8/143 • Number of events 11 • 54 weeks
|
|
Nervous system disorders
Dyskinesia
|
3.5%
5/143 • Number of events 7 • 54 weeks
|
|
Psychiatric disorders
Somnolence
|
11.9%
17/143 • Number of events 18 • 54 weeks
|
|
Psychiatric disorders
Insomnia
|
7.0%
10/143 • Number of events 10 • 54 weeks
|
|
Psychiatric disorders
Hallucination
|
3.5%
5/143 • Number of events 7 • 54 weeks
|
|
Psychiatric disorders
Hallucination Visual
|
3.5%
5/143 • Number of events 5 • 54 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
3.5%
5/143 • Number of events 11 • 54 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.5%
5/143 • Number of events 5 • 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