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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-060287 | Other Identifier | JAPIC |
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The primary objective of this study is to investigate efficacy and safety of SPM 962 in advanced Parkinson's Disease (PD) patients in a multi-center, placebo-controlled study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12 weeks of dose titration/maintenance period). Recommended maintenance dose range is also to be investigated with distribution of the maintenance dose and accumulated response rate of efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPM 962 | Experimental | SPM 962 transdermal patch |
|
| Placebo | Placebo Comparator | Placebo transdermal patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPM 962 | Drug | SPM 962 transdermal patch once a daily up to 36.0 mg/day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score | 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. | baseline, 12 weeks after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| UPDRS Part 2 Sum Score (Average Score of on State and Off State) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyoji Imaoka, Mr | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chubu Region | Japan | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | SPM 962 | SPM 962 transdermal patch |
| FG001 | Placebo | Placebo transdermal patch |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Excluded 1 sebject of each arm by vaiolation of protocol
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| ID | Title | Description |
|---|---|---|
| BG000 | SPM 962 | SPM 962 transdermal patch |
| BG001 | Placebo | Placebo transdermal patch |
| 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 | Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score | 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. | Full analysis set (FAS), last observation carried forward (LOCF) | Posted | Mean | Standard Deviation | Scores on a scale | baseline, 12 weeks after dosing |
|
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 | SPM 962 | SPM 962 transdermal patch |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.1)J | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.1)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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| Placebo |
| Drug |
Placebo transdermal patch |
|
| baseline, 12 weeks after dosing |
| Off Time | Mean change (LOCF) from baseline in off time at 12 weeks after dosing. | baseline, 12 weeks after dosing |
| Effective Rate in UPDRS Part 3 Sum Score | Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 3 sum score at 12 weeks after dosing. | Baseline, 12 weeks after dosing |
| UPDRS Part 1 Sum Score | 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. | Baseline, 12 weeks after dosing |
| Effective Rate in Off Time | Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in off time at 12 weeks after dosing. | Baseline, 12 weeks after dosing. |
| UPDRS Part 2 Sum Score (on State) | 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. | Baseline, 12 weeks after dosing |
| UPDRS Part 2 Sum Score (Off State) | 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. | Baseline, 12 weeks after dosing |
| UPDRS Part 4 Sum Score | 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. | Baseline, 12 weeks after dosing |
| Total of UPDRS Part 2 Sum Score (Average Score of on State and Off State) and UPDRS Part 3 Sum Score | 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. | Baseline, 12 weeks after dosing |
| 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. | 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. | Baseline, 12 weeks after dosing |
| The Modified Hoehn & Yahr Severity of Illness | 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. | Baseline, 12 weeks after dosing |
| Hokkaido Region |
| Japan |
| Kanto Region | Japan |
| Kinki Region | Japan |
| Kyushu Region | Japan |
| Shikoku 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 |
|
| OG001 |
| Placebo |
Placebo transdermal patch |
|
|
| Secondary | UPDRS Part 2 Sum Score (Average Score of on State and Off State) | 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. | FAS, LOCF | Posted | Mean | Standard Deviation | Scores on a scale | baseline, 12 weeks after dosing |
|
|
|
| Secondary | Off Time | Mean change (LOCF) from baseline in off time at 12 weeks after dosing. | FAS subjects with measurable off time data at baseline, LOCF | Posted | Mean | Standard Deviation | Hours | baseline, 12 weeks after dosing |
|
|
|
| Secondary | Effective Rate in UPDRS Part 3 Sum Score | Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 3 sum score at 12 weeks after dosing. | FAS, LOCF | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, 12 weeks after dosing |
|
|
|
| Secondary | UPDRS Part 1 Sum Score | 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. | FAS, LOCF | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 12 weeks after dosing |
|
|
|
| Secondary | Effective Rate in Off Time | Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in off time at 12 weeks after dosing. | FAS subjects with measurable off time data at baseline, LOCF | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, 12 weeks after dosing. |
|
|
|
| Secondary | UPDRS Part 2 Sum Score (on State) | 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. | FAS, LOCF | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 12 weeks after dosing |
|
|
|
| Secondary | UPDRS Part 2 Sum Score (Off State) | 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. | FAS, LOCF | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 12 weeks after dosing |
|
|
|
| Secondary | UPDRS Part 4 Sum Score | 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. | FAS, LOCF | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 12 weeks after dosing |
|
|
|
| Secondary | Total of UPDRS Part 2 Sum Score (Average Score of on State and Off State) and UPDRS Part 3 Sum Score | 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. | FAS, LOCF | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 12 weeks after dosing |
|
|
|
| Secondary | 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. | 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. | FAS, LOCF | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 12 weeks after dosing |
|
|
|
| Secondary | The Modified Hoehn & Yahr Severity of Illness | 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. | FAS, LOCF | Posted | Number | Percentage of participants | Baseline, 12 weeks after dosing |
|
|
|
| 3 |
| 87 |
| 80 |
| 87 |
| EG001 | Placebo | Placebo transdermal patch | 3 | 87 | 59 | 87 |
| Hernia Inguinal | Gastrointestinal disorders | MedDRA (10.1)J | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (10.1)J | Non-systematic Assessment |
|
| Arthritis Bacterial | Infections and infestations | MedDRA (10.1)J | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (10.1)J | Non-systematic Assessment |
|
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA (10.1)J | Non-systematic Assessment |
|
| Consciousness Loss | Nervous system disorders | MedDRA (10.1)J | Non-systematic Assessment |
|
| Neuroleptic Malignant | Nervous system disorders | MedDRA (10.1)J | Non-systematic Assessment |
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| Delusion | Psychiatric disorders | MedDRA (10.1)J | Non-systematic Assessment |
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| Hallucination, Auditory | Psychiatric disorders | MedDRA (10.1)J | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (10.1)J | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (10.1)J | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (10.1)J | Non-systematic Assessment |
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| Gastric Ulcer | Gastrointestinal disorders | MedDRA (10.1)J | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (10.1)J | Non-systematic Assessment |
|
| Application Site Reaction | General disorders | MedDRA (10.1)J | Non-systematic Assessment |
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| Application Site Erythema | General disorders | MedDRA (10.1)J | Non-systematic Assessment |
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| Application Site Pruritus | General disorders | MedDRA (10.1)J | Non-systematic Assessment |
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| Feeling Abnormal | General disorders | MedDRA (10.1)J | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (10.1)J | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA (10.1)J | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (10.1)J | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (10.1)J | Non-systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA (10.1)J | Non-systematic Assessment |
|
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA (10.1)J | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (10.1)J | Non-systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (10.1)J | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1)J | Non-systematic Assessment |
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| Dyskinesia | Nervous system disorders | MedDRA (10.1)J | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (10.1)J | Non-systematic Assessment |
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| Dizziness Postural | Nervous system disorders | MedDRA (10.1)J | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (10.1)J | Non-systematic Assessment |
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| Somnolence | Psychiatric disorders | MedDRA (10.1)J | Non-systematic Assessment |
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| Hallucination Visual | Psychiatric disorders | MedDRA (10.1)J | Non-systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA (10.1)J | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (10.1)J | Non-systematic Assessment |
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| Upper Respiratory Tract Inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1)J | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Decreased |
|