oxybutynin and Parkinson Disease

oxybutynin has been researched along with Parkinson Disease in 50 studies

oxybutynin: RN given refers to parent cpd
oxybutynin : A racemate comprising equimolar amounts of (R)-oxybutynin and esoxybutynin. An antispasmodic used for the treatment of overactive bladder.

Parkinson Disease: A progressive, degenerative neurologic disease characterized by a TREMOR that is maximal at rest, retropulsion (i.e. a tendency to fall backwards), rigidity, stooped posture, slowness of voluntary movements, and a masklike facial expression. Pathologic features include loss of melanin containing neurons in the substantia nigra and other pigmented nuclei of the brainstem. LEWY BODIES are present in the substantia nigra and locus coeruleus but may also be found in a related condition (LEWY BODY DISEASE, DIFFUSE) characterized by dementia in combination with varying degrees of parkinsonism. (Adams et al., Principles of Neurology, 6th ed, p1059, pp1067-75)

Research

Studies (50)

Authors

Clinical Trials (16)

Trial Overview

Trial Outcomes

"Change in Absolute Time Spent on From Baseline to the End of Double-blind Maintenance Period"

"A subject has been considered on when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.~Absolute time on is defined as the mean number of hours marked on during a 24-hour period from all valid daily diary cards." (NCT01646255)
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

"Change in Relative Time Spent on From Baseline to the End of Double-blind Maintenance Period"

"A subject has been considered on when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was off when taking his/her L-dopa, he/she recorded the exact time their status changed to on.~Relative time spent on will be calculated in two stages. Each valid daily diary will have an associated relative time on calculated as relative time on for day = 100*[total absolute time on for day/ absolute time awake for day]. Relative time spent on is then calculated by averaging the daily relative time on for the valid days of that visit." (NCT01646255)
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

"Change in the Number of Off Periods From Baseline to the End of Double-blind Maintenance Period"

"A subject has been considered off when he/she began to lose the optimum effects of anti-Parkinson's medication." (NCT01646255)
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

"Change in Unified Parkinson's Disease Rating Scale (UPDRS Part III Motor Examination) During on Periods From Baseline to the End of Double-blind Maintenance Period"

"The UPDRS Part III (motor subscale) assessment consists of 27 questions, measured on a 5-Point scale (0 to 4). The sum score is calculated as sum of these 27 individual questions. This score ranges from 0 to 108, higher scores denote greater disability.~A subject has been considered on when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'." (NCT01646255)
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

"Percent Change in Absolute Time Spent Off From Baseline to the End of Double-blind Maintenance Period"

"A subject has been considered off when he/she began to lose the optimum effects of anti-Parkinson's medication.~Absolute time off is defined as the mean number of hours marked off during a 24-hour period from all valid daily diary cards." (NCT01646255)
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

"Percent Change in Absolute Time Spent on From Baseline to the End of Double-blind Maintenance Period"

"A subject has been considered on when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.~Note for percent change calculations: when absolute time at Baseline was 0 hours, the absolute Baseline value was assumed to be 1 minute for calculation purposes." (NCT01646255)
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

"Percent Change in Relative Time Spent Off From Baseline to the End of Double-blind Maintenance Period"

"A subject has been considered off when he/she began to lose the optimum effects of anti-Parkinson's medication.~Relative time spent off will be calculated in two stages. Each valid daily diary will have an associated relative time off calculated as relative time off for day = 100*[total absolute time off for day/ absolute time awake for day]. Relative time spent off is then calculated by averaging the daily relative time off for the valid days of that visit." (NCT01646255)
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

"Percent Change in Relative Time Spent on From Baseline to the End of Double-blind Maintenance Period"

"A subject has been considered on when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was off when taking his/her L-dopa, he/she recorded the exact time their status changed to on.~Note for percent change calculations: when relative time at Baseline was 0%, the relative Baseline value was assumed to be 0.1 for calculation purposes.~Relative time spent on will be calculated in two stages. Each valid daily diary will have an associated relative time on calculated as relative time on for day = 100*[total absolute time on for day/ absolute time awake for day]. Relative time spent on is then calculated by averaging the daily relative time on for the valid days of that visit." (NCT01646255)
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period

"A subject has been considered off when he/she began to lose the optimum effects of anti-Parkinson's medication. A negative mean indicates a reduction of the time off during the conduct of the study" (NCT01646255)
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Change in Status of the Subject (Off) After Wake-up From Baseline to the End of Double-blind Maintenance Period

"A subject has been considered off when he/she began to lose the optimum effects of anti-Parkinson's medication.~The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the off state is presented below." (NCT01646255)
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Change in Status of the Subject (on) After Wake-up With Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period

"A subject has been considered on when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.~The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the on with troublesome dyskinesia state is presented below." (NCT01646255)
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Change in Status of the Subject (on) After Wake-up Without Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period

"A subject has been considered on when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.~The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the on without troublesome dyskinesia state is presented below." (NCT01646255)
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Percentage of Responders From Baseline to the End of the Doubleblind Maintenance Period

A Responder is defined as a subject with an ≥ 30 % decrease in absolute time spent 'off' (NCT01646255)
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)

Change in Average Adhesiveness Score of 2 Days of 24 Hours Patch Application as Rated by the Investigator (or Designee) Assessed According to the EMA Draft Guideline

"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012).~0 = > 95 - 100 % of the patch area adheres~1 = > 90 - 95 % of the patch adheres~2 = > 85 - 90 % of the patch adheres~3 = > 80 - 85 % of the patch adheres~4 = > 75 - 80 % of the patch adheres~5 = > 70 - 75 % of the patch adheres~6 = ≥ 50 - 70 % of the patch adheres~7 = < 50 % of the patch adheres~8 = Patch completely detached~The recorded scores 6, 7, and 8 were combined in order to create a cumulative group less than or equal to 70 % adhered or patch detachment which was regarded as significant patch adhesion failure in the draft EMA guideline.~The average of patches 1 and 2 is presented by Treatment Arm below." (NCT02230904)
Timeframe: Patch adhesiveness was measured after 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5

Change in Average Patch Adhesiveness Score of 2 Days of 24 Hour Patch Application as Rated by the Investigator (or Designee), Assessed According to the FDA/Center for Drug Evaluation and Research (CDER) Score

"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores:~0 (>95-100% of patch adheres) >> 0 (FDA/CDER)~1 (>90-95% of patch adheres) >> 0 (FDA/CDER)~2 (>85-90% of patch adheres) >> 1 (FDA/CDER)~3 (>80-85% of patch adheres) >> 1 (FDA/CDER)~4 ( >75-80% of patch adheres) >> 1 (FDA/CDER)~5 (>70-75% of patch adheres) >> 2 (FDA/CDER)~6 (≥50-70% of patch adheres) >> 2 (FDA/CDER)~7 (<50 % of patch adheres) >> 3 (FDA/CDER)~8 (Patch completely detached) >> 4 (FDA/CDER)~Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies." (NCT02230904)
Timeframe: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5

Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2

"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012).~0 = >95 - 100 % of the patch area adheres~1 = >90 - 95 % of the patch adheres~2 = >85 - 90 % of the patch adheres~3 = >80 - 85 % of the patch adheres~4 = >75 - 80 % of the patch adheres~5 = >70 - 75 % of the patch adheres~6 = ≥50 - 70 % of the patch adheres~7 = <50 % of the patch adheres~8 = Patch completely detached~The recorded scores 6, 7, and 8 were combined in order to create a cumulative group less than or equal to 70 % adhered or patch detachment which was regarded as significant patch adhesion failure in the draft EMA guideline." (NCT02230904)
Timeframe: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5

Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 1

"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores:~0 (>95-100% of patch adheres) >> 0 (FDA/CDER)~1 (>90-95% of patch adheres) >> 0 (FDA/CDER)~2 (>85-90% of patch adheres) >> 1 (FDA/CDER)~3 (>80-85% of patch adheres) >> 1 (FDA/CDER)~4 ( >75-80% of patch adheres) >> 1 (FDA/CDER)~5 (>70-75% of patch adheres) >> 2 (FDA/CDER)~6 (≥50-70% of patch adheres) >> 2 (FDA/CDER)~7 (<50 % of patch adheres) >> 3 (FDA/CDER)~8 (Patch completely detached) >> 4 (FDA/CDER)~Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies." (NCT02230904)
Timeframe: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4

Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 2

"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores:~0 (>95-100% of patch adheres) >> 0 (FDA/CDER)~1 (>90-95% of patch adheres) >> 0 (FDA/CDER)~2 (>85-90% of patch adheres) >> 1 (FDA/CDER)~3 (>80-85% of patch adheres) >> 1 (FDA/CDER)~4 ( >75-80% of patch adheres) >> 1 (FDA/CDER)~5 (>70-75% of patch adheres) >> 2 (FDA/CDER)~6 (≥50-70% of patch adheres) >> 2 (FDA/CDER)~7 (<50 % of patch adheres) >> 3 (FDA/CDER)~8 (Patch completely detached) >> 4 (FDA/CDER)~Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies." (NCT02230904)
Timeframe: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5

Patch Adhesiveness Per Day as Rated by the Investigator or Designee 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 1

"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012).~0 = >95 - 100 % of the patch area adheres~1 = >90 - 95 % of the patch adheres~2 = >85 - 90 % of the patch adheres~3 = >80 - 85 % of the patch adheres~4 = >75 - 80 % of the patch adheres~5 = >70 - 75 % of the patch adheres~6 = ≥50 - 70 % of the patch adheres~7 = <50 % of the patch adheres~8 = Patch completely detached~The recorded scores 6, 7, and 8 were combined in order to create a cumulative group less than or equal to 70 % adhered or patch detachment which was regarded as significant patch adhesion failure in the draft EMA guideline." (NCT02230904)
Timeframe: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4

Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1

"The subject assessed the patch adhesiveness by using the following score:~0 = Satisfied with adhesiveness~1 = Moderately satisfied with adhesiveness~2 = Moderately unsatisfied with adhesiveness~3 = Unsatisfied with adhesiveness" (NCT02230904)
Timeframe: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4

Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2

"The subject assessed the patch adhesiveness by using the following score:~0 = Satisfied with adhesiveness~1 = Moderately satisfied with adhesiveness~2 = Moderately unsatisfied with adhesiveness~3 = Unsatisfied with adhesiveness" (NCT02230904)
Timeframe: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5

Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33)

"The NADCS assesses sleep-related motor complaints including nocturnal akinesia, dystonia and painful cramps by an ordinal severity scale.~The NADCS total score ranges from 0 (normal) to 4 (maximum severity). NADCS value was missing for one subject at Visit 7." (NCT00599339)
Timeframe: 33 months

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33)

The Unified Parkinson's disease rating scale (UPDRS) Part III (Motor Examination) contains 31 questions. Each question ranges from 0 (best possible outcome) to 4 (worst outcome). The total score ranges from 0 (best possible outcome) to 124 (worst outcome). (NCT00599339)
Timeframe: From Baseline to Visit 7 (Month 33)

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33)

"The Unified Parkinson's disease rating scale (UPDRS) question 32 of part IV asks. What Proportion of the waking day are dyskinesias present? Answers range from 0 (None) to 4 (76-100 % of the day)." (NCT00599339)
Timeframe: From Baseline to Visit 7 (Month 33)

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33)

"The Unified Parkinson's disease rating scale (UPDRS) Part IV question 33 asks for complications of therapy in the past week, through the question How disabling are the dyskinesias ? Answers range from 0 (Not disabling) to 4 (Completely disabling)." (NCT00599339)
Timeframe: From Baseline to Visit 7 (Month 33)

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33)

"The Unified Parkinson's disease rating scale (UPDRS) Part IV question 39 asks What proportion of the waking day is the patient off, on average? Answers range from 0 (None) to 4 (76-100 % of the day)." (NCT00599339)
Timeframe: 33 months

Hoehn & Yahr Stage at Visit 7 (Month 33)

"The Hoehn and Yahr staging of Parkinson's disease in the on stage, if applicable, had to be completed by the physician.~Possible staging:~0 No signs of disease~1 Unilateral disease~2 Bilateral disease without impairment of balance~3 Mild to moderate bilateral disease, some postural instability, physically dependent~4 Severe disability, still able to walk or stand unassisted~5 Wheelchair bound or bedridden unless aided" (NCT00599339)
Timeframe: 33 months

Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months)

The analysis was performed for the non-disjunctive classification into patients at risk to develop an Adverse Event associated with Rotigotine and patients at risk to develop an Adverse Event not associated with Rotigotine. (NCT00599339)
Timeframe: 33 months

Number of Subjects Who Withdrew From the Trial Due to an Adverse Event

Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. (NCT00599196)
Timeframe: six years

Number of Subjects With at Least One Adverse Event During This Open-label Extension Study

Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. (NCT00599196)
Timeframe: six years

Mean Epworth Sleepiness Scale Score During the Open-label Extension

The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness. (NCT00599196)
Timeframe: Visit 10 (end of year 1), Visit 14 (end of year 2), Visit 18 (end of year 3), Visit 22 (end of year 4), Visit 26 (end of year 5), Visit 30 (end of year 6), End of Treatment (last study visit or early withdrawal visit)

Apparent Dose

Apparent dose of unconjugated rotigotine in mg. The apparent dose was calculated by subtraction of the determined residual content of each rotigotine patch from the nominal content of rotigotine in the patch. (NCT01059903)
Timeframe: 24 hours

Apparent Total Body Clearance (CL/f) of Unconjugated Rotigotine

The CL/f of unconjugated rotigotine is the apparent total body clearance. (NCT01059903)
Timeframe: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h

AUC(0- ∞) Norm (Apparent Dose)

The AUC(0-inf) norm (apparent dose) is the area under the plasma concentration-time curve from zero up to infinity normalized by apparent dose (mg). (NCT01059903)
Timeframe: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h

AUC(0- ∞) Norm (Body Weight)

The AUC(0-inf) norm (BW) is the area under the plasma concentration-time curve from zero up to infinity normalized by body weight (kg). (NCT01059903)
Timeframe: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h

AUC(0- ∞) of Unconjugated Rotigotine

The AUC(0- ∞) is the area under the plasma concentration-time curve from zero up to infinity (NCT01059903)
Timeframe: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h

AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine

The AUC(0-tz) norm (apparent dose) is the area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg). (NCT01059903)
Timeframe: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h

AUC(0-tz) Norm (Body Weight) of Unconjugated Rotigotine

The AUC(0-tz) norm (BW) is the area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg). (NCT01059903)
Timeframe: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h

AUC(0-tz) of Unconjugated Rotigotine

The AUC(0-tz) is the area under the concentration-time curve from zero up to the last analytically quantifiable concentration. (NCT01059903)
Timeframe: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h

Cmax of Unconjugated Rotigotine

The Cmax is the maximum plasma concentration. (NCT01059903)
Timeframe: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h

Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine

The Cmax, norm (apparent dose) is the maximum plasma concentration normalized by apparent dose (mg). (NCT01059903)
Timeframe: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h

Cmax, Norm (Body Weight) of Unconjugated Rotigotine

The Cmax, norm (BW) is the maximum plasma concentration normalized by body weight (kg). (NCT01059903)
Timeframe: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h

Mean Residence Time (MRT) of Unconjugated Rotigotine

The MRT is the mean residence time. (NCT01059903)
Timeframe: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h

Rate Constant of Elimination (λz) of Unconjugated Rotigotine

The λz of unconjugated rotigotine is the rate constant of elimination. (NCT01059903)
Timeframe: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h

Terminal Half-Life (t1/2) of Unconjugated Rotigotine

the t1/2 of unconjugated rotigotine is the terminal half-life, calculated as t1/2=ln2/ λz. (NCT01059903)
Timeframe: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h

Tmax of Unconjugated Rotigotine

The tmax is the time to reach maximum plasma concentration after patch application. (NCT01059903)
Timeframe: 0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h

Apparent Dose

Apparent dose of unconjugated rotigotine in mg. The Apparent dose of unconjugated rotigotine was determined from the patches removed on Day 2. (NCT00881894)
Timeframe: 48 hours

AUC(0-∞) of Unconjugated Rotigotine

The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity. (NCT00881894)
Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

AUC(0-tz) of Unconjugated Rotigotine

The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration. (NCT00881894)
Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application

AUC(0-tz)Norm (Apparent Dose) of Unconjugated Rotigotine

The AUC(0-tz)Norm (Apparent dose) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg). (NCT00881894)
Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

AUC(0-tz)Norm (BW) of Unconjugated Rotigotine

The AUC(0-tz)Norm (BW) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg). (NCT00881894)
Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

CL/f of Unconjugated Rotigotine

The CL/f is the apparent total body clearance. (NCT00881894)
Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

Cmax of Unconjugated Rotigotine

The Cmax is the maximum plasma concentration. (NCT00881894)
Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine

The Cmax,Norm (Apparent dose) is the maximum plasma concentration normalized by apparent dose. (NCT00881894)
Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

Cmax,Norm (BW) of Unconjugated Rotigotine

The Cmax,Norm (BW) is the maximum plasma concentration normalized by body weight (kg). (NCT00881894)
Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

MRT of Unconjugated Rotigotine

The MRT is the mean residence time. (NCT00881894)
Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24(before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

t1/2 of Unconjugated Rotigotine

The t1/2 is the terminal half- life. (NCT00881894)
Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

Tmax of Unconjugated Rotigotine

The Tmax is the time to reach a maximum plasma concentration after patch application. (NCT00881894)
Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

λz of Unconjugated Rotigotine

The λz is the rate constant of elimination. (NCT00881894)
Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

Change From Baseline to Visit 3 in the Assessment of Intensity of Gastrointestinal (GI) Complaints for Any Reason as Per Visual Analogue Scale (VAS)

Patients were asked to classify the intensity of their GI complaints on a scale ranging from 0 (no complaints) to 100 (extremely severe complaints). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement. (NCT01159691)
Timeframe: From Baseline to Visit 3 (approximately 6 weeks)

Change From Baseline to Visit 3 in the Sum Score of Gastrointestinal (GI) Complaints

"Sum score of GI complaints was calculated from frequency and intensity of the complaints. The intensity of GI complaints during the last week ranges from 0 (no complaints) to 3 (severe) and the frequency of these complaints during the last week ranges from 0 (never) to 4 (every day).~For each of the seven GI complaints assessed at a visit (swallowing disorders, heartburn, feeling of fullness, nausea, vomiting, abdominal pain, and diarrhea), intensity and frequency were multiplied to achieve individual item scores of GI complaints (range: 0 - 12).~Finally, the sum score of GI complaints per visit was calculated by accumulating 6 of the 7 item scores (excluding swallowing disorders, which was recorded at Baseline only) for patients with valid values in each score (range: 0 - 72). Negative values indicate an improvement from Baseline to Visit 3 with larger negative values showing a better improvement." (NCT01159691)
Timeframe: From Baseline to Visit 3 (approximately 6 weeks)

Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 2

"Patient satisfaction referring to GI complaints is classified into 5 categories:~Missing~Very satisfied~Satisfied~Moderately satisfied~Not satisfied." (NCT01159691)
Timeframe: At Visit 2 (after approximately 2-4 weeks)

Assessment of Patient Satisfaction Referring to Gastrointestinal (GI) Complaints Following Treatment Switch to Neupro® at Visit 3

"Patient satisfaction referring to GI complaints is classified into 5 categories:~Missing~Very satisfied~Satisfied~Moderately satisfied~Not satisfied." (NCT01159691)
Timeframe: At Visit 3 (after approximately 6 weeks)

Mean Score of the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication

"The caregivers were asked to fill out a questionnaire composed of 7 questions covering caregiving aspects. The mean score is calculated from the scores for the single responses which are rated from 'great disadvantages' to 'great advantages' and scored on a 5-point scale from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers." (NCT01330290)
Timeframe: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.

Mean Score of the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication

"The physicians were asked to fill out a questionnaire composed of 10 questions covering medical and caregiving aspects. The mean score is calculated from the scores for the single responses which are rated from 'great disadvantages' to 'great advantages' and scored on a 5-point scale from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians." (NCT01330290)
Timeframe: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.

Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Care-giving Efforts

"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers." (NCT01330290)
Timeframe: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.

Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance

"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers." (NCT01330290)
Timeframe: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.

Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia

"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers." (NCT01330290)
Timeframe: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.

Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication

"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers." (NCT01330290)
Timeframe: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.

Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Nausea and/or Vomiting in Patients With Nausea and/or Vomiting

"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers." (NCT01330290)
Timeframe: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.

Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration

"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers." (NCT01330290)
Timeframe: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.

Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients

"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers." (NCT01330290)
Timeframe: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.

Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance

"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians." (NCT01330290)
Timeframe: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.

Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dose Adaption

"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians." (NCT01330290)
Timeframe: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.

Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia

"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians." (NCT01330290)
Timeframe: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.

Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication

"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians." (NCT01330290)
Timeframe: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.

Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Nausea and/or Vomiting in Patients With Nausea and/or Vomiting.

"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians." (NCT01330290)
Timeframe: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.

Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Resorption

"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians." (NCT01330290)
Timeframe: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.

Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Risk of Interaction With Other Treatments

"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians." (NCT01330290)
Timeframe: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.

Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Surgery Requiring General Anaesthesia

"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians." (NCT01330290)
Timeframe: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.

Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration

"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians." (NCT01330290)
Timeframe: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.

Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients

"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians." (NCT01330290)
Timeframe: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.

Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Application Form in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support

"The physician was asked if he / she prescribed Neupro® due to application form in idiopathic Parkinson's Disease patients requiring caregiver support. The possible answers were applicable and not applicable." (NCT01330290)
Timeframe: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.

Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Substance in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support

"The physician was asked if he / she prescribed Neupro® due to substance in idiopathic Parkinson's Disease patients requiring caregiver support. The possible answers were applicable and not applicable." (NCT01330290)
Timeframe: Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.

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. (NCT01300819)
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)

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" (NCT01300819)
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)

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" (NCT01300819)
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)

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" (NCT01300819)
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)

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" (NCT01300819)
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)

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" (NCT01300819)
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)

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" (NCT01300819)
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)

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" (NCT01300819)
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)

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" (NCT01300819)
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)

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" (NCT01300819)
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)

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. (NCT01300819)
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)

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. (NCT01300819)
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)

"Change From Baseline to the End of the Maintenance Period in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Subscale) in on State"

"Part III of the Unified Parkinson's Disease Rating Scale (UPDRS) assesses motor function. The UPDRS is completed by questioning the subject about his/her general state in conjunction with any observations made by the investigator (or designee) since the previous visit.~The UPDRS Part III (motor subscale) had to be measured in the on state and consisted of 27 items and sub items scored between 0 and 4. The sum score ranged between 0 and 108 and was calculated as sum of the 27 individual scores. If 1 or more items were missing and could not be substituted with a previous post-Baseline value, the sum score was also missing.~A negative value indicates an improvement." (NCT01782222)
Timeframe: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)

Change From Baseline to the End of the Maintenance Period in the Score of the Apathy Evaluation Scale (AS) Rated by the Caregiver (Where Available)

"The Apathy Scale (AS) is an abbreviated version of the Apathy Evaluation Scale. The AS (Starkstein et al, 1992) consists of 14 items phrased as questions by the examiner that are to be answered on a 4-point Likert scale. It was developed specifically for subjects with Parkinson's disease because the Apathy Evaluation Scale was considered too demanding.~The questions comprising the AS were answered by the caregiver. The questions were asked in a structured interview format. The caregiver was interviewed by appropriate medical staff and asked questions about the subject in the third person.The total scores for Apathy Evaluation Scale ranges from 0 (best possible outcome) to 42 (worst possible outcome)." (NCT01782222)
Timeframe: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)

Change From Baseline to the End of the Maintenance Period in the Score of the Apathy Evaluation Scale (AS) Rated by the Patient

"The Apathy Scale (AS) is an abbreviated version of the Apathy Evaluation Scale. The AS (Starkstein et al, 1992) consists of 14 items phrased as questions by the examiner that are to be answered on a 4-point Likert scale. It was developed specifically for subjects with Parkinson's disease because the Apathy Evaluation Scale was considered too demanding.~The questions comprising the AS were answered by the subject. The total scores for Apathy Evaluation Scale ranges from 0 (best possible outcome) to 42 (worst possible outcome)." (NCT01782222)
Timeframe: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)

Change From Baseline to the End of the Maintenance Period in the Sum Score of the 8-item Parkinson's Disease Questionnaire (PDQ-8)

The 8-Item Parkinson's Disease Questionnaire (PDQ-8) (Peto et al, 1998) is a self-administered questionnaire that provides a reliable measure of overall health status. The PDQ-8 collects 8 items with 5 categories each (0=never, 1=occasionally, 2=sometimes, 3=often, 4=always or cannot do at all). The total score was calculated by summing the scores of all applicable questions and convert the resulting sum to a summary index score between 0 and 100 by multiplying with 100/32. A negative value indicates an improvement. (NCT01782222)
Timeframe: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)

Change From Baseline to the End of the Maintenance Period in the Sum Score of the Beck Depression Inventory Second Edition (BDI-II)

The Beck Depression Inventory (BDI) is a self-report instrument to measure depression symptoms and severity (Beck et al, 1961). The BDI-II is a revised version of the scale in order to be more consistent with the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for depression (Beck et al, 1996). There are 21 items in the BDI-II, classified as cognitive-affective (Items 1-13) and somatic-performance (Items 14-21) subscales. The degree of severity is indicated on a 4-point scale; items are rated from 0 (not at all) to 3 (extreme form of each symptom). Scores of 0-13 indicate minimal depression, 14-19 indicate mild depression, 20-28 indicate moderate depression, and 29-63 indicate severe depression. (NCT01782222)
Timeframe: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)

Change From Baseline to the End of the Maintenance Period in the Sum Score of the Mood / Cognition Domain of the Nonmotor Symptom Assessment Scale (NMSS)

"Nonmotor performance was assessed via the Nonmotor Symptom Assessment Scale (NMSS), an accepted scale that has been validated in an international study (Naidu et al, 2006; Chaudhuri et al, 2007), at the Baseline Visit as well as at the end of the Maintenance Period. The severity and frequency of the subject's nonmotor symptoms were assessed by the investigator (or designee) in the following 9 domain categories: cardiovascular, including falls; sleep/fatigue; mood/cognition; perceptual problems/hallucinations; attention/memory; gastrointestinal tract; urinary; sexual function; and miscellaneous.~Items are scored for severity (from 0 (none) to 3 (severe)) and frequency (from 1 (rarely) to 4 (very frequent )). The score was calculated as severity x frequency. The theoretical minimum is 0 (best possible outcome) and maximum total score is 360 points (worst possible outcome)." (NCT01782222)
Timeframe: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)

Change From Baseline to the End of the Maintenance Period in the Sum Score of the Snaith Hamilton Pleasure Scale (SHAPS)

The Snaith Hamilton Pleasure Scale (SHAPS) (Snaith et al, 1995) is a self-report instrument developed for the assessment of hedonic capacity. The sum of the 14 items scores range from 0 to 14. A higher score represents more anhedonic symptoms. (NCT01782222)
Timeframe: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)

Change From Baseline to the End of the Maintenance Period in the Total Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II (Activities of Daily Living) + III (Motor Symptoms)

Part II of the Unified Parkinson's Disease Rating Scale (UPDRS) assesses the subject's activities of daily living. Part III assesses motor function. The UPDRS is completed by questioning the subject about his/her general state in conjunction with any observations made by the investigator (or designee) since the previous visit. Part II is subject-rated and Part III is physician-rated. The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The sum score was calculated as the sum of these 13 individual scores. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score was calculated as sum of these 27 individual scores. The sum score of UPDRS Parts II and III is the sum of the corresponding single sum scores. A negative value indicates an improvement. (NCT01782222)
Timeframe: Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)

Change From Baseline to the End of the Maintenance Period in the Score of the Clinical Global Impression Scale (CGI) Item I (Severity of Illness)

"The Clinical Global Impression (CGI) scales (Guy and Bonato, 1970) were initially developed for a risk-benefit estimation within the treatment of mentally ill patients. The 4 global scales (severity of illness, change in severity from Baseline, therapeutic efficacy, and tolerability of treatment) are used as different measures of treatment outcome in different kinds of pharmacological studies.~The CGI Item 1 (severity of illness) collected 1 answer out of 8 categories (0-'Not assessed', 1-'Normal, not at all ill', 2-'Borderline ill', 3-'Mildly ill', 4-'Moderately ill', 5-'Markedly ill', 6-'Severely ill', and 7-'Among the most extremely ill patients') at each assessment. The category 0-'Not assessed' was considered as missing and therefore used neither for calculation nor for display purposes." (NCT01782222)
Timeframe: Baseline (Visit 2) until End of the Maintenance Period/Early Withdrawal (up to 19 weeks after Baseline)

Change From Baseline to the End of Maintenance Period in the Combined Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (ADL) Plus Part III (Motor Subscale)

The combined score of UPDRS part II and UPDRS part III is the sum of the individual scores and threfore ranges from 0 (normal) to 160 (severe). (NCT01523301)
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)

Change From Baseline to the End of Maintenance Period in the Score of Apathy Scale (AS)

The AS is an abbreviated version of the Apathy Scale (AS). The AS consists of 14 items phrased as questions that are to be answered on a four-point Likert scale. It was developed specifically for patients with Parkinson Disease (PD). For questions 1-8, the scoring system is the following: not at all = 3 points; slightly = 2 points; some =1 point, a lot = 0 point. For questions 9-14: the scoring system is the following: not at all = 0 points; slightly = 1 point; some = 2 points; a lot = 3 points. Adding all scores provides the final score with a range from 0 to 42. (NCT01523301)
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)

Change From Baseline to the End of Maintenance Period in the Score of Beck Depression Inventory (BDI-II)

The Beck Depression Inventory II (BDI-II) is a self-report instrument to measure Depression symptoms and severity. There are 21 items in the BDI-II. Scores of 0-13 are considered minimal depression; 14-19 indicates mild depression; 20-28 indicates moderate depression; and 29-63 indicates severe depression. (NCT01523301)
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)

Change From Baseline to the End of Maintenance Period in the Score of Snaith-Hamilton Pleasure Scale (SHAPS)

The SHAPS is a self-report instrument developed for the assessment of hedonic capacity. The sum of the 14 items scores ranges from 0 to 14. A higher score represents more anhedonic symptoms. (NCT01523301)
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)

Change From Baseline to the End of Maintenance Period in the Score of the Hamilton Depression Scale (HAM-D)

The HAM-D consists of 17 items. Nine of the items are scored on a 5-point scale, ranging from 0 to 4. The remaining 8 items are scored on a 3-point scale, from 0 to 2. Therefore, the total score ranges between 0 to 52, with a cutoff score of 15/16 diagnosing major depressive disorder. (NCT01523301)
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)

Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living-ADL Subscale)

The UPDRS Part II is a tool to measure Activities in Daily Living - it includes speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and adjusting clothes, falling (unrelated to freezing), freezing when walking, walking, tremor, and sensory complaints related to Parkinsonism. Each of the 13 questions is measured on a scale from 0 (normal) to 4 (severe). The total score of UPDRS part II ranges from 0 (normal) to 52 (severe). (NCT01523301)
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)

Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Subscale)

Improvement of motor symptoms is measured by the change from Baseline in UPDRS Part III motor score. The UPDRS Part III is an accepted and validated scale for the assessment of motor function in Parkinson's disease. Each of the elements in the UPDRS Part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total score of UPDRS part III ranges from 0 (normal) to 108 (severe abnormalities). (NCT01523301)
Timeframe: From Baseline (Week 0) to end of Maintenance Period (up to Week 15)

Change in Early Morning UPDRS Part III Score

The Unified Parkinson´s Disease Rating Scale Part III score is an accepted and validated sumscore of 14 items for the assessment of motor function in Parkinson´s disease. Each of the 14 items in the UPDRS part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. (NCT00474058)
Timeframe: From baseline to end of maintenance (after 4 weeks maintenance)

Change in Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS)

Subjects were asked to assess nocturnal akinesia, dystonia and cramps, using an ordinal severity scale. While a score of 0= normal and 4= maximal severity, subjects could also rate their symptoms with values of 0.5, 1.5, 2.5, 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps scores were used to evaluate sleep. (NCT00474058)
Timeframe: From baseline to end of maintenance (after 4 weeks maintenance)

Change in Number of Nocturias

Nocturia is the need to get up during the night and interrupt sleep in order to urinate. It is a typical nocturnal symptom of Parkinson´s disease. The change from baseline in number of nocturias was used to evaluate improvements in sleep disorders. (NCT00474058)
Timeframe: From baseline to end of maintenance (after 4 weeks maintenance)

Change in Parkinson's Disease Sleep Scale (PDSS)

The Parkinson´s Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep and nocturnal disability in Parkinson´s disease. The item- scores can range between 0= never and 4= very often. The PDSS score is a sumscore of all 15 questions. (NCT00474058)
Timeframe: From baseline to end of maintenance (after 4 weeks maintenance)

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