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Safety of SPM 962 in a once-daily repeated long-term treatment in Parkinson's disease patients who are not concomitantly treated with L-dopa will be investigated with a doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPM 962 | Experimental | SPM 962 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 |
|---|---|---|
| Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters | 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 | Up to 55 weeks after dosing |
| Skin Irritation Score of the Application Site | 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 | Up to 55 weeks after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score | 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. |
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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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SPM 962 | SPM 962 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 | Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters | 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 | Safety set (SS) | Posted | Number | participants | Up to 55 weeks after dosing |
|
|
54 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 |
|---|---|---|---|---|---|
| Positional Vertigo | Ear and labyrinth disorders | MedDRA (11.1)J | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth 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. | +81-3-6361-7366 |
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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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| ID | Term |
|---|---|
| C047508 | rotigotine |
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| Baseline, Up to 54 weeks after dosing |
| Hokkaido Region |
| Japan |
| Kanto Region | Japan |
| Kinki Region | Japan |
| Kyushu Region | Japan |
| Shikoku Region | Japan |
| Tohoku Region | Japan |
| Lost to Follow-up |
|
| Discontinuation criteria |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score | 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. | Full analysis set (FAS), last observation carried forward (LOCF) | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Up to 54 weeks after dosing |
|
|
|
| Primary | Skin Irritation Score of the Application Site | 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 | SS | Posted | Number | participants | Up to 55 weeks after dosing |
|
|
|
| 24 |
| 143 |
| 138 |
| 143 |
| Cataract | Eye disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Gastric Ulcer Bleeding | Gastrointestinal disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Gallbladder Polyp | Hepatobiliary disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA (11.1)J | Non-systematic Assessment |
|
| Clavicle Fracture | Injury, poisoning and procedural complications | MedDRA (11.1)J | Non-systematic Assessment |
|
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA (11.1)J | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1)J | Non-systematic Assessment |
|
| Gastric Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1)J | Non-systematic Assessment |
|
| Altered State Of Consciousness | Nervous system disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Cerebral Infarction | Nervous system disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Disease Parkinson's | Nervous system disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Myoclonus | Nervous system disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Neuroleptic Malignant | Nervous system disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Delusion | Psychiatric disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Renal Impairment | Renal and urinary disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Application Site Reaction | General disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.1)J | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (11.1)J | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.1)J | Non-systematic Assessment |
|
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA (11.1)J | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Somnolence | Psychiatric disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Insomnia | Psychiatric 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 |
|
| Upper Respiratory Tract Inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (11.1)J | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|
|
| ++ |
|
| +++ |
|
| ++++ |
|
| +++> |
|