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The primary objective of this trial is to establish the maximum maintenance dose of SPM 962 in patients with Parkinson's disease in a multi-center, uncontrolled, open-label study by conducting safety evaluation of each patient following once-daily transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg. (The administration period will consist of a standard 8-week dose-titration period, 4-week dose-maintenance period, and a dose de-escalation period) Exploratory evaluation of each patient's maintenance dose will also be conducted with attention to patient safety. The relationship of pharmacokinetics, safety, and efficacy will also be examined.
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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 |
|---|---|---|
| Maintenance Dose of the SPM962 | The maintenance dose of the SPM 962 was examined based on the safety and efficacy. | Up to 12 weeks after dosing |
| 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 following the initiation of study treatment. | Up to 12 weeks after dosing |
| Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy |
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Inclusion Criteria:
For subject with early and advanced Parkinson's disease
For subject with early Parkinson's disease
For subject with dvanced Parkinson's disease
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 |
|---|---|---|---|---|---|---|
| Kanto Region | Japan | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Early-stage Parkinson's Disease | Subjects with early Parkinson's disease received SPM 962 transdermal patch |
| FG001 | Advanced Parkinson's Disease | Subjects with advanced Parkinson's disease received SPM 962 transdermal patch |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Early-stage Parkinson's Disease | |
| BG001 | Advanced Parkinson's Disease | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Maintenance Dose of the SPM962 | The maintenance dose of the SPM 962 was examined based on the safety and efficacy. | Subjects in the safety analysis set who entered the maintenance period | Posted | Number | participants | Up to 12 weeks after dosing |
|
5 to 13 weeks depending on maintenance dose
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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 | Early-stage Parkinson's Disease |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Carcinoma Prostate | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1)J | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (8.1)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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Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score and Part 3 sum 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 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 |
| UPDRS Part 3 Sum Score for Advanced Parkinson's Disease With Concomitant L-dopa Therapy | Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 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, 12 weeks after dosing |
| UPDRS Part 2 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy | Mean change (LOCF) from baseline in UPDRS Part 2 sum score 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 3 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy | Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 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, 12 weeks after dosing |
| UPDRS Part 2 Sum Score (on State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy. | 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) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy. | 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 2 Sum Score (Average Score of on State and Off State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy | 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. | Baseline, 12 weeks after dosing |
| Total of UPDRS Part 2 Sum Score (Average Score of on State and Off State) and Part 3 Sum Score for Advanced Parkinson's Disease With Concomitant L-dopa Therapy | Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score (average score of on state and off state) and 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 |
| Off Time for Advanced Parkinson's Disease With Concomitant L-dopa Therapy | Mean change (LOCF) from baseline in off time at 12 weeks after dosing. | Baseline, 12 weeks after dosing |
| Kinki Region |
| Japan |
| Kyushu Region | Japan |
| Shikoku Region | Japan |
| Tohoku Region | Japan |
Total of all reporting groups
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters | Incidence and severity of adverse events, vital signs, and laboratory parameters following the initiation of study treatment. | Safety analysis set | Posted | Number | participants | Up to 12 weeks after dosing |
|
|
|
| Secondary | Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy | Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score and Part 3 sum 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 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. | Efficacy analysis set, last observation carried forward (LOCF) | Posted | Mean | Standard Deviation | Scores on a scale | baseline, 12 weeks after dosing |
|
|
|
| Secondary | UPDRS Part 3 Sum Score for Advanced Parkinson's Disease With Concomitant L-dopa Therapy | Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 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. | Efficacy analysis set, LOCF | Posted | Mean | Standard Deviation | Scores on a scale | baseline, 12 weeks after dosing |
|
|
|
| Secondary | UPDRS Part 2 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy | Mean change (LOCF) from baseline in UPDRS Part 2 sum score 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. | Efficacy analysis set, LOCF | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 12 weeks after dosing |
|
|
|
| Secondary | UPDRS Part 3 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy | Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 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. | Efficacy analysis set, LOCF | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 12 weeks after dosing |
|
|
|
| Secondary | UPDRS Part 2 Sum Score (on State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy. | 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. | Efficacy analysis set, LOCF | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 12 weeks after dosing |
|
|
|
| Secondary | UPDRS Part 2 Sum Score (Off State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy. | 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. | Efficacy analysis set, LOCF | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 12 weeks after dosing |
|
|
|
| Secondary | UPDRS Part 2 Sum Score (Average Score of on State and Off State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy | 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. | Efficacy analysis set, 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 Part 3 Sum Score for Advanced Parkinson's Disease With Concomitant L-dopa Therapy | Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score (average score of on state and off state) and 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. | Efficacy analysis set, LOCF | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 12 weeks after dosing |
|
|
|
| Secondary | Off Time for Advanced Parkinson's Disease With Concomitant L-dopa Therapy | Mean change (LOCF) from baseline in off time at 12 weeks after dosing. | Subjects with measurable off time data at baseline and after dosing, LOCF | Posted | Mean | Standard Deviation | Hours | Baseline, 12 weeks after dosing |
|
|
|
| 1 |
| 21 |
| 20 |
| 21 |
| EG001 | Advanced Parkinson's Disease | 3 | 43 | 41 | 43 |
| Pneumonia | Infections and infestations | MedDRA (8.1)J | Non-systematic Assessment |
|
| Abnormal Behaviour | Psychiatric disorders | MedDRA (8.1)J | Non-systematic Assessment |
|
| Suicide Attempt | Psychiatric disorders | MedDRA (8.1)J | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (8.1)J | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (8.1)J | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (8.1)J | Non-systematic Assessment |
|
| Administration Site Reaction | General disorders | MedDRA (8.1)J | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA (8.1)J | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (8.1)J | Non-systematic Assessment |
|
| Blood Urea Increased | Investigations | MedDRA (8.1)J | Non-systematic Assessment |
|
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA (8.1)J | Non-systematic Assessment |
|
| Blood Urine Present | Investigations | MedDRA (8.1)J | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (8.1)J | Non-systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (8.1)J | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (8.1)J | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (8.1)J | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (8.1)J | Non-systematic Assessment |
|
| Parkinson's Disease | Nervous system disorders | MedDRA (8.1)J | Non-systematic Assessment |
|
| Dizziness Postural | Nervous system disorders | MedDRA (8.1)J | Non-systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA (8.1)J | Non-systematic Assessment |
|
| hypoesthesia | Nervous system disorders | MedDRA (8.1)J | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (8.1)J | Non-systematic Assessment |
|
| Hallucination Visual | Psychiatric disorders | MedDRA (8.1)J | Non-systematic Assessment |
|
| Orthostatic Hypotension | Vascular disorders | MedDRA (8.1)J | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| SAEs |
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| Severe AEs |
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| Discontinuation due to AEs |
|
| Death |
|
| AEs related to laboratory parameters |
|
| Discontinuation due to AEs related to labs |
|
| Clinically significant QTc prolongation |
|