| Primary | Change From Baseline to the End of Maintenance in Total Nonmotor Symptoms Scale (NMSS) Score | The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in the following 9 domain categories: cardiovascular, including falls; sleep/fatigue; mood/cognition; perceptual problems/hallucinations; attention/memory; gastrointestinal tract; urinary; sexual function; miscellaneous. Severity and frequency are rated using a 4-point scale ranging from 0 (none) to 3 (severe; major source of distress or disturbance to subject) for severity and from 1 (rarely) to 4 (very frequent [daily or all the time]) for frequency. The total NMSS score ranges from 0 to 350. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS. | This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle. | Posted | | Mean | Standard Deviation | scores on a scale | | From Baseline (Day 1) to end of 12-week Maintenance (Day 84) | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients. Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day. | | OG001 | Rotigotine | Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients. Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-19.1± 24.2
- OG001-23.1± 23.4
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Null hypothesis: mean change in the total Nonmotor Symptoms Scale (NMSS) score is the same for rotigotine- and placebo-treated group. | ANCOVA | Analysing was performed with ANCOVA model, adjusted for several terms. | 0.147 | Two-sided p-value is presented. No multiplicity adjustment is performed. | Mean Difference (Final Values) | -3.58 | | | 2-Sided | 95 | -8.43 | 1.26 | | | | No | Superiority or Other | | |
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| Secondary | Change From Baseline to the End of Maintenance in Total Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score | The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a scale for the assessment of function in Parkinson's Disease. UPDRS Part III measures Motor Function. It consists of 14 items with 27 questions, each ranging from 0 to 4. The sum score for the UPDRS Part III ranges from 0 to 108. A higher score indicates greater disability. A negative change from Baseline to end of Maintenance score indicates improvement. | This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle. | Posted | | Mean | Standard Deviation | scores on a scale | | From Baseline (Day 1) to end of 12-week Maintenance (Day 84) | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients. Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day. | | OG001 | Rotigotine | |
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| Secondary | Change From Baseline to the End of Maintenance in Health-related Quality of Life (HRQL) Measured by a 39-item Parkinson's Disease Questionnaire (PDQ-39) | Parkinson's Disease Questionnaire - 39 (PDQ-39) is a self-administered questionnaire. It comprises of 39 questions, relating to eight key areas of health and daily activities, including both Motor and Non-motor symptoms. It is scored on a scale of zero to 100, with lower scores indicating better health and high scores more severe symptoms in change from Baseline to end of Maintenance. | This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle. | Posted | | Mean | Standard Deviation | scores on a scale | | From Baseline (Day 1) to end of 12-week Maintenance (Day 84) | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients. Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day. | | OG001 | Rotigotine | Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients. Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day. |
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| Secondary | Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Cardiovascular | The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale. The final score is derived from multiplying the severity score and the frequency score. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS. The possible min/max final scores per subdomain are calculated as follows: Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain: Subdomain Cardiovascular (2 questions): range 0 - 24 | This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle. | Posted | | Mean | Standard Deviation | scores on a scale | | From Baseline (Day 1) to end of 12-week Maintenance (Day 84) | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients. Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day. |
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| Secondary | Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Sleep/Fatigue | The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale. The final score is derived from multiplying the severity score and the frequency score. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS. The possible min/max final scores per subdomain are calculated as follows: Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain: Subdomain Sleep/Fatigue (4 questions): range 0-48 | This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle. | Posted | | Mean | Standard Deviation | scores on a scale | | From Baseline (Day 1) to end of 12-week Maintenance (Day 84) | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients. Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day. |
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| Secondary | Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Mood/Cognition | The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale. The final score is derived from multiplying the severity score and the frequency score. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS. The possible min/max final scores per subdomain are calculated as follows: Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain: Subdomain Mood/Cognition (6 questions): range 0 - 72 | This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle. | Posted | | Mean | Standard Deviation | scores on a scale | | From Baseline (Day 1) to end of 12-week Maintenance (Day 84) | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients. Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day. |
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| Secondary | Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Perception/Hallucinations | The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale. The final score is derived from multiplying the severity score and the frequency score. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS. The possible min/max final scores per subdomain are calculated as follows: Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain: Subdomain Perception/Hallucinations (3 questions): range 0 - 36 | This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle. | Posted | | Mean | Standard Deviation | scores on a scale | | From Baseline (Day 1) to end of 12-week Maintenance (Day 84) | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients. Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day. |
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| Secondary | Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Attention/Memory, | The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale. The final score is derived from multiplying the severity score and the frequency score. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS. The possible min/max final scores per subdomain are calculated as follows: Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain: Subdomain Attention/Memory (3 questions): range 0 - 36 | This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle. | Posted | | Mean | Standard Deviation | scores on a scale | | From Baseline (Day 1) to end of 12-week Maintenance (Day 84) | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients. Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day. |
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| Secondary | Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Gastrointestinal Tract | The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale. The final score is derived from multiplying the severity score and the frequency score. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS. The possible min/max final scores per subdomain are calculated as follows: Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain: Subdomain Gastrointestinal tract (3 questions): range 0 - 36 | This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle. | Posted | | Mean | Standard Deviation | scores on a scale | | From Baseline (Day 1) to end of 12-week Maintenance (Day 84) | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients. Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day. |
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| Secondary | Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Urinary | The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale. The final score is derived from multiplying the severity score and the frequency score. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS. The possible min/max final scores per subdomain are calculated as follows: Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain: Subdomain Urinary (3 questions): range 0 - 36 | This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle. | Posted | | Mean | Standard Deviation | scores on a scale | | From Baseline (Day 1) to end of 12-week Maintenance (Day 84) | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients. Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day. |
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| Secondary | Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Sexual Function | The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale. The final score is derived from multiplying the severity score and the frequency score. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS. The possible min/max final scores per subdomain are calculated as follows: Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain: Subdomain Sexual function (2 questions): range 0 - 24 | This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle. | Posted | | Mean | Standard Deviation | scores on a scale | | From Baseline (Day 1) to end of 12-week Maintenance (Day 84) | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients. Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day. |
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| Secondary | Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Miscellaneous | The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale. The final score is derived from multiplying the severity score and the frequency score. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS. The possible min/max final scores per subdomain are calculated as follows: Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain: Subdomain Miscellaneous (4 questions): range 0 - 48 | This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle. | Posted | | Mean | Standard Deviation | scores on a scale | | From Baseline (Day 1) to end of 12-week Maintenance (Day 84) | | | | ID | Title | Description |
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| OG000 | Placebo | Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients. Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day. |
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