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To investigate superiority of SPM 962 over placebo in early Parkinson's disease patients in a multi-center, placebo-controlled, double-blind study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12-week dose titration/maintenance period)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPM 962 | Drug | transdermal application, 1 time per day |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to the End of Maintenance Period in Total of Each Sum Score of UPDRS Part 2 and Part 3 | 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. | baseline, end of maintenance period |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Rate in Total of Each Sum Score of UPDRS Part 2 and Part 3 | 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 | baseline, end of maintenance period |
| Mean Change in UPDRS Part 2 Sum Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katsuhisa Saito | New Product Evaluation and Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chubu Region | Japan | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | SPM962 | transdermal application of SPM962, 1 time per day |
| FG001 | Placebo | transdermal application of placebo, 1 time per day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Excluded 3 subjects (SPM962:2, placebo:1) because lack of assessment of efficacy, and 1 (plasebo) for not matching with the inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | SPM962 | transdermal application of SPM962, 1 time per day |
| BG001 | Placebo | transdermal application of placebo, 1 time per day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to the End of Maintenance Period in Total of Each Sum Score of UPDRS Part 2 and Part 3 | 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. | Full analysis set (FAS), last observation carried forward (LOCF) | Posted | Mean | Standard Deviation | Scores on a scale | baseline, end of maintenance period |
|
14 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SPM962 | transdermal application of SPM962, 1 time per day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral Infarction | Vascular disorders | MedDRA (11.1)J | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.1)J | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research and Development | Otsuka Pharmaceutical Co., Ltd. | +81-3-6131-7366 |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Drug |
transdermal application, 1 time per day |
|
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. |
| Baseline, every two weeks |
| Efficacy Rate in UPDRS Part 2 Sum Score | Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score at every two weeks after dosing. | Baseline, every two weeks |
| UPDRS Part 3 Sum Score | 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. | Baseline, every two weeks |
| Efficacy Rate in UPDRS Part 3 Sum Score | Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score at every two weeks after dosing. | Baseline, every two weeks |
| UPDRS Part 1 Sum Score | 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. | Baseline, every two weeks |
| UPDRS Part 4 Sum Score | 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. | Baseline, every two weeks |
| Total of Each Sum Score of UPDRS Part 1, 2, 3, and 4 | 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. | Baseline, every two weeks |
| The Modified Hoehn and Yahr Stage | 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. | Baseline, end of maintenance period |
| Hokkaido Region |
| Japan |
| Kanto Region | Japan |
| Kinki Region | Japan |
| Kyushu Region | Japan |
| Tohoku Region | Japan |
| Withdrawal by Subject |
|
| Physician Decision |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
transdermal application of SPM962, 1 time per day
| OG001 | Placebo | transdermal application of placebo, 1 time per day |
|
|
|
| Secondary | Efficacy Rate in Total of Each Sum Score of UPDRS Part 2 and Part 3 | 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 | FAS, LOCF | Posted | Number | 95% Confidence Interval | Percentage of participants | baseline, end of maintenance period |
|
|
|
|
| Secondary | Mean Change in UPDRS Part 2 Sum Score | 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. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, every two weeks |
|
|
|
| Secondary | Efficacy Rate in UPDRS Part 2 Sum Score | Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score at every two weeks after dosing. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, every two weeks |
|
|
|
| Secondary | UPDRS Part 3 Sum Score | 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. | FAS, LOCF | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, every two weeks |
|
|
|
| Secondary | Efficacy Rate in UPDRS Part 3 Sum Score | Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score at every two weeks after dosing. | FAS, LOCF | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, every two weeks |
|
|
|
| Secondary | UPDRS Part 1 Sum Score | 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. | FAS, LOCF | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, every two weeks |
|
|
|
| Secondary | UPDRS Part 4 Sum Score | 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. | FAS, LOCF | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, every two weeks |
|
|
|
| Secondary | Total of Each Sum Score of UPDRS Part 1, 2, 3, and 4 | 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. | FAS, LOCF | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, every two weeks |
|
|
|
| Secondary | The Modified Hoehn and Yahr Stage | 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. | FAS, LOCF | Posted | Number | Percentage of participants | Baseline, end of maintenance period |
|
|
|
| 2 |
| 90 |
| 73 |
| 90 |
| EG001 | Placebo | transdermal application of placebo, 1 time per day | 0 | 90 | 55 | 90 |
| Myelopathy | Nervous system disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Application Site Reaction | General disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA (11.1)J | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.1)J | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Hallucination Visual | Psychiatric disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.1)J | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Somnolence | Psychiatric disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Risk Difference (RD) |
| 26.1 |
| 2-Sided |
| 95 |
| 12.0 |
| 40.2 |
| No |
| Superiority or Other |
| Week 6 |
|
| Week 8 |
|
| Week 10 |
|
| Week 12 |
|
| End of maintenance period |
|
| ≥20% decrease (Week 6) |
|
| ≥20% decrease (Week 8) |
|
| ≥20% decrease (Week 10) |
|
| ≥20% decrease (Week 12) |
|
| ≥20% decrease (End of maintenance period) |
|
| ≥30% decrease (Week 2) |
|
| ≥30% decrease (Week 4) |
|
| ≥30% decrease (Week 6) |
|
| ≥30% decrease (Week 8) |
|
| ≥30% decrease (Week 10) |
|
| ≥30% decrease (Week 12) |
|
| ≥30% decrease (End of maintenance period) |
|
| Week 6 |
|
| Week 8 |
|
| Week 10 |
|
| Week 12 |
|
| End of maintenance period |
|
| ≥20% decrease (Week 6) |
|
| ≥20% decrease (Week 8) |
|
| ≥20% decrease (Week 10) |
|
| ≥20% decrease (Week 12) |
|
| ≥20% decrease (End of maintenance period) |
|
| ≥30% decrease (Week 2) |
|
| ≥30% decrease (Week 4) |
|
| ≥30% decrease (Week 6) |
|
| ≥30% decrease (Week 8) |
|
| ≥30% decrease (Week 10) |
|
| ≥30% decrease (Week 12) |
|
| ≥30% decrease (End of maintenance period) |
|
| Week 6 |
|
| Week 8 |
|
| Week 10 |
|
| Week 12 |
|
| End of maintenance period |
|
| Week 6 |
|
| Week 8 |
|
| Week 10 |
|
| Week 12 |
|
| End of maintenance period |
|
| Week 6 |
|
| Week 8 |
|
| Week 10 |
|
| Week 12 |
|
| End of maintenance period |
|
| Decreased |
|