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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-090888 | Other Identifier | JAPIC |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPM 962 | Experimental | SPM 962 transdermal patch |
|
| Ropinirole | Active Comparator | Ropinirole tablet |
|
| Placebo | Placebo Comparator | SPM962 placebo patch and Ropinirole placebo tab |
|
| 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 Score (UPDRS) Part 3 Sum Score | Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 16 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, 16 weeks after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| UPDRS Part 3 Sum Score | Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 8 and 10 weeks after dosing. UPDRS 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, 8 and 10 weeks after dosing |
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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 | Ropinirole | Ropinirole tablet |
| FG002 | Placebo | SPM962 placebo patch and Ropinirole placebo tab |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
6 subjects were excluded. Met the exclusion criteria: 2 of SPM962, 1 of ropinirole Lack of efficacy observation: 2 of SPM962, 1 of Placebo
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| ID | Title | Description |
|---|---|---|
| BG000 | SPM 962 | SPM 962 transdermal patch |
| BG001 | Ropinirole | Ropinirole tablet |
| BG002 |
| 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 Score (UPDRS) Part 3 Sum Score | Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 16 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, 16 weeks after dosing |
|
21 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 |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA(13.1)J | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA(13.1)J | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research and Development | Otsuka Pharmaceutical Co, Lts. | +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 |
|---|---|
| C046649 | ropinirole |
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| Ropinirole |
| Drug |
Ropinirole oral administration TID up to 15.0 mg/day |
|
| Placebo | Drug | SPM962-placebo patch and Ropinirole-placebo tab |
|
| UPDRS Part 2 Sum Score | Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) at 16 weeks after dosing. UPDRS 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, 16 weeks after dosing |
| Off Time | Mean change (LOCF) from baseline in off time at 16 weeks after dosing. Off-time is a state where L-Dopa becomes ineffective. Off-time was measured by patient diary in hours/day. | Baseline, 16 weeks after dosing |
| Parkinson's Disease Sleep Scale-2 (PDSS-2) | Mean change (LOCF) from baseline in PDSS-2 sum score at 16 weeks after dosing. PDSS-2 is a scale for assessing sleep disorders in Parkinson's disease. PDSS consists of 15 questions about sleep and nocturnal disturbances. The score of each question ranges from 0 (never) to 4 (very frequent). The sum of each question serves as the scale score. Thus a decrease in the scores means improvement. | Baseline, 16 weeks after dosing |
| On Time | Mean change (LOCF) from baseline in on time at 16 weeks after dosing. On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day. | Baseline, 16 weeks after dosing |
| On Time Without Dyskinesia Disturbing Daily Activities | Mean change (LOCF) from baseline in on time without dyskinesia disturbing daily activities at 16 weeks after dosing. On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day. | Baseline, 16 weeks after dosing |
| On Time With Dyskinesia Disturbing Daily Activities | Mean change (LOCF) from baseline in on time with dyskinesia disturbing daily activities at 16 weeks after dosing (rate against on time). | Baseline, 16 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 (on state) at 16 weeks after dosing. | Baseline, 16 weeks after dosing |
| Effective Rate in UPDRS Part 2 Sum Score | Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score (average scores of on state and off state) at 16 weeks after dosing. | Baseline, 16 weeks after dosing |
| Effective Rate in Off Time | Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in off time at 16 weeks after dosing. On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day. | Baseline, 16 weeks after dosing |
| Clinical Global Impression (CGI) | Change (LOCF) from baseline in CGI score. CGI improvement is a clinician-reported scale for assessing how much the patient's illness has improved or worsened from baseline. The scale scoring criteria are 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse. A decrease in the scores means improvement. | Baseline, 16 weeks after dosing |
| Dystonia (at an Early Hour) | Change (LOCF) from baseline in occurrence of Dystonia (at an early hour). | Baseline, 16 weeks after dosing |
| Dystonia (in the Daytime) | Change (LOCF) from baseline in occurrence of Dystonia (in the daytime). | Baseline, 16 weeks after dosing |
| Chugoku Region |
| Japan |
| Hokkaido Region | Japan |
| Kanto Region | Japan |
| Kinki Region | Japan |
| Kyushu Region | Japan |
| Shikoku Region | Japan |
| Tohoku Region | Japan |
| Withdrawal by Subject |
|
| Protocol Violation |
|
| Discontinuation criteria |
|
| Physician Decision |
|
| Placebo |
SPM962 placebo patch and Ropinirole placebo tab |
| BG003 | 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 | Ropinirole | Ropinirole oral administration TID up to 15.0 mg/day |
| OG002 | Placebo | SPM962-placebo patch and Ropinirole-placebo tab |
|
|
| Secondary | UPDRS Part 3 Sum Score | Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 8 and 10 weeks after dosing. UPDRS 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, 8 and 10 weeks after dosing |
|
|
|
| Secondary | UPDRS Part 2 Sum Score | Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) at 16 weeks after dosing. UPDRS 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, 16 weeks after dosing |
|
|
|
| Secondary | Off Time | Mean change (LOCF) from baseline in off time at 16 weeks after dosing. Off-time is a state where L-Dopa becomes ineffective. Off-time was measured by patient diary in hours/day. | FAS subjects with measurable off time data at baseline, LOCF | Posted | Mean | Standard Deviation | Hours/day | Baseline, 16 weeks after dosing |
|
|
|
| Secondary | Parkinson's Disease Sleep Scale-2 (PDSS-2) | Mean change (LOCF) from baseline in PDSS-2 sum score at 16 weeks after dosing. PDSS-2 is a scale for assessing sleep disorders in Parkinson's disease. PDSS consists of 15 questions about sleep and nocturnal disturbances. The score of each question ranges from 0 (never) to 4 (very frequent). The sum of each question serves as the scale score. Thus a decrease in the scores means improvement. | FAS, LOCF | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 16 weeks after dosing |
|
|
|
| Secondary | On Time | Mean change (LOCF) from baseline in on time at 16 weeks after dosing. On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day. | FAS, LOCF | Posted | Mean | Standard Deviation | Hours/day | Baseline, 16 weeks after dosing |
|
|
|
| Secondary | On Time Without Dyskinesia Disturbing Daily Activities | Mean change (LOCF) from baseline in on time without dyskinesia disturbing daily activities at 16 weeks after dosing. On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day. | FAS, LOCF Evaluation for this outcome measure was not possible, because only 22.6% (37/164), 12.7% (21/165), and 6.0% (5/83) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had dyskinesia disturbing daily activities on either day from baseline until the end of titration/maintenance. | Posted | Mean | Standard Deviation | Hours/day | Baseline, 16 weeks after dosing |
|
|
|
| Secondary | On Time With Dyskinesia Disturbing Daily Activities | Mean change (LOCF) from baseline in on time with dyskinesia disturbing daily activities at 16 weeks after dosing (rate against on time). | FAS, LOCF Evaluation for this outcome measure was not possible, because only 22.6% (37/164), 12.7% (21/165), and 6.0% (5/83) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had dyskinesia disturbing daily activities on either day from baseline until the end of titration/maintenance period. | Posted | Mean | Standard Deviation | Hours | Baseline, 16 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 (on state) at 16 weeks after dosing. | FAS, LOCF | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, 16 weeks after dosing |
|
|
|
| Secondary | Effective Rate in UPDRS Part 2 Sum Score | Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score (average scores of on state and off state) at 16 weeks after dosing. | FAS, LOCF | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, 16 weeks after dosing |
|
|
|
| Secondary | Effective Rate in Off Time | Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in off time at 16 weeks after dosing. On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day. | FAS subjects with measurable off time data at baseline, LOCF | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, 16 weeks after dosing |
|
|
|
| Secondary | Clinical Global Impression (CGI) | Change (LOCF) from baseline in CGI score. CGI improvement is a clinician-reported scale for assessing how much the patient's illness has improved or worsened from baseline. The scale scoring criteria are 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse. A decrease in the scores means improvement. | FAS, LOCF | Posted | Number | Percentage of Participants | Baseline, 16 weeks after dosing |
|
|
|
| Secondary | Dystonia (at an Early Hour) | Change (LOCF) from baseline in occurrence of Dystonia (at an early hour). | FAS, LOCF Evaluation for this outcome measure was not possible, because 87.1% (142/163), 88.5% (146/165), and 91.4% (74/81) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had no dystonia in the day time at baseline. | Posted | Number | Percentage of participants | Baseline, 16 weeks after dosing |
|
|
|
| Secondary | Dystonia (in the Daytime) | Change (LOCF) from baseline in occurrence of Dystonia (in the daytime). | Appropriate interpretation for this outcome measure was not possible, because 87.1% (142/163), 88.5% (146/165), and 91.4% (74/81) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had no dystonia in the day time at baseline. | Posted | Number | Percentage of Participants | Baseline, 16 weeks after dosing |
|
|
|
| 7 |
| 168 |
| 140 |
| 168 |
| EG001 | Ropinirole | Ropinirole tablet | 5 | 167 | 99 | 167 |
| EG002 | Placebo | SPM962 placebo patch and Ropinirole placebo tab | 6 | 85 | 40 | 85 |
| Gastric Ulcer | Gastrointestinal disorders | MedDRA(13.1)J | Non-systematic Assessment |
|
| Gastric Ulcer Bleeding | Gastrointestinal disorders | MedDRA(13.1)J | Non-systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA(13.1)J | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA(13.1)J | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA(13.1)J | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA(13.1)J | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA(13.1)J | Non-systematic Assessment |
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| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA(13.1)J | Non-systematic Assessment |
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| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA(13.1)J | Non-systematic Assessment |
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| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA(13.1)J | Non-systematic Assessment |
|
| Carcinoma Gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(13.1)J | Non-systematic Assessment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(13.1)J | Non-systematic Assessment |
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| Posture Abnormal | Nervous system disorders | MedDRA(13.1)J | Non-systematic Assessment |
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| Disease Parkinson's | Nervous system disorders | MedDRA(13.1)J | Non-systematic Assessment |
|
| Cerebral Artery Embolism | Nervous system disorders | MedDRA(13.1)J | Non-systematic Assessment |
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| Delusion | Psychiatric disorders | MedDRA(13.1)J | Non-systematic Assessment |
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| Caruncle Urethral | Renal and urinary disorders | MedDRA(13.1)J | Non-systematic Assessment |
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| Embolism Pulmonary | Respiratory, thoracic and mediastinal disorders | MedDRA(13.1)J | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA(13.1)J | Non-systematic Assessment |
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| Application Site Reaction | General disorders | MedDRA(13.1)J | Non-systematic Assessment |
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| Application Site Pruritus | General disorders | MedDRA(13.1)J | Non-systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA(13.1)J | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA(13.1)J | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA(13.1)J | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA(13.1)J | Non-systematic Assessment |
|
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA(13.1)J | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA(13.1)J | Non-systematic Assessment |
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| Dyskinesia | Nervous system disorders | MedDRA(13.1)J | Non-systematic Assessment |
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| Hallucination Visual | Psychiatric disorders | MedDRA(13.1)J | Non-systematic Assessment |
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| Somnolence | Psychiatric disorders | MedDRA(13.1)J | Non-systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA(13.1)J | Non-systematic Assessment |
|
| Upper Respiratory Tract Inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA(13.1)J | Non-systematic Assessment |
|
| Orthostatic Hypotension | Vascular disorders | MedDRA(13.1)J | Non-systematic Assessment |
|
Not provided
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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|
|
|
|
| Increased |
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| Increased (by at least 2 points) |
|
|
| Increased |
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| Increased (by at least 2 events) |
|
|
| Increased |
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| Increased (by at least 2 events) |
|