Parkinson's Disease
Conditions
Keywords
Parkinson's disease, rotigotine, patch, transdermal, dopamine agonist, off time, Neupro
Brief summary
The purpose of this study is to show Rotigotine dose response at four doses of Rotigotine used with L-dopa in treating advanced stage Parkinson's disease.
Detailed description
To maintain treatment blind, two different active patch sizes were used (10 cm\^2 & 20 cm\^2). Placebo patches matched according to size and appearance. During the trial subjects applied up to three patches, active and placebo, to achieve their assigned daily dose.
Interventions
DRUGRotigotine
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
OTHERPlacebo
Placebo transdermal patch applied daily
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* PD greater than 3 years * Stable dose L-dopa but symptoms not adequately controlled and have off time * Able and willing to complete diary on specific days
Exclusion criteria
* Previous use of rotigotine or Neupro * Atypical Parkinson's syndrome * Pallidotomy * Thalamotomy * Deep brain stimulation * Fetal tissue transplant * Dementia * Psychosis * Hallucinations * Epilepsy * Renal or hepatic dysfunction * Clinically relevant cardiac dysfunction * Symptomatic orthostatic hypotension * Skin sensitivity to adhesives or unresolved contact dermatitis * History of chronic alcohol or drug abuse * Pregnant or of child-bearing potential * Impulse control disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change in the Absolute Time Spent Off From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. | Time Off is defined as when the patient does not have the effect of anti-Parkinson's medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Change in the Absolute Time Spent on From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. | Time On is defined as when the patient has the effect of anti-Parkinson's medication. |
| The Change in the Relative Time Spent on From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. | Time On is defined as when the patient has the effect of anti-Parkinson's medication. |
| The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. | — |
| The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II From Baseline to the End of the Maintenance Period | From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. | The Unified Parkinson's Disease Rating Scale (UPDRS) Part II is a scale for the assessment of function in Parkinson's disease. UPDRS Part II measures Activities of Daily Living. It consists of 13 questions, each ranging from 0 to 4. The sum score of the UPDRS Part II ranges from 0 to 52. A higher score indicates greater disability. A negative change score indicates improvement. |
| The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III From Baseline to the End of the Maintenance Period | From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. | 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 score indicates improvement. |
| The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present? | From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. | Item = Duration (question #32) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - What proportion of the waking day are dyskinesias present? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same. |
| The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias? | From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. | Item = Disability (question #33) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - How disabling are the dyskinesias? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same. |
| The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias? | From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. | Item = Painful Dyskinesia (question #34) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - How painful are the dyskinesias? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same. |
| The Change in Relative Time Spent Off From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. | Time Off is defined as when the patient does not have the effect of anti-Parkinson's medication. |
| The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Predictable? | From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. | Item = Are off periods predictable (question #36) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates off periods are predictable. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same. |
| The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Unpredictable? | From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. | Item = Are off periods unpredictable (question #37) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates off periods are unpredictable. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same. |
| The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do Off Periods Come on Suddenly? | From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. | Item = Do off periods come on suddenly, within a few seconds (question #38) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates off periods come on suddenly, within a few seconds. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same. |
| The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject Off, on Average? | From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. | Item = What proportion of the waking day is the subject off, on average (question #39) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 - 4 points (4 = maximum). A higher score indicates the subject is off a larger portion of the waking day. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same. |
| The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting? | From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. | Item = Does the patient have anorexia, nausea, or vomiting (question #40) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has anorexia, nausea, or vomiting. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same. |
| The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence? | From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. | Item = Does the patient have any sleep disturbances such as insomnia or hypersomnolence (question #41) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has sleep disturbances such as insomnia or hypersomnolence. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same. |
| The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis? | From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. | Item = Does the patient have symptomatic orthostasis (question #42) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has symptomatic orthostasis. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same. |
| The Change in Number of Off Periods From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. | Time Off is defined as when the patient does not have the effect of anti-Parkinson's medication. |
| The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia | From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)]. | Item = Presence of Early Morning Dystonia (question #35) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates early morning dystonia. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same. |
Countries
Chile, India, Mexico, Peru, United States
Participant flow
Recruitment details
This Phase III study started in July 2007 with subjects from the United States, Mexico, Peru, Chile, and India. The primary completion date and study completion date occurred in July 2011. The Participant Flow and Baseline Characteristics are represenative of the Safety Set (SS), which is 514 subjects.
Pre-assignment details
The study outcome measures are representative of the Full Analysis Set (FAS), which is 502 subjects. The Full Analysis Set (FAS) consisted of all subjects who were randomized, received at least 1 dose of study medication, and had a valid Baseline primary efficacy measurement and at least 1 valid post-Baseline primary efficacy measurement.
Participants by arm
| Arm | Count |
|---|---|
| Rotigotine 2 mg/24 hr 2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks | 101 |
| Rotigotine 4 mg/24 hr 4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks | 107 |
| Rotigotine 6 mg/24 hr 6 mg/24 hr (one 10 cm\^2 & one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks | 104 |
| Rotigotine 8 mg/24 hr 8 mg/24 hr (two 10 cm\^2 & one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks | 94 |
| Placebo | 108 |
| Total | 514 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 12 | 15 | 12 | 5 | 17 |
| Overall Study | Dispensing error | 1 | 0 | 0 | 1 | 0 |
| Overall Study | Family Problem | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 3 | 0 | 2 | 2 | 7 |
| Overall Study | Lost to Follow-up | 1 | 0 | 4 | 2 | 2 |
| Overall Study | Protocol Violation | 1 | 1 | 2 | 0 | 0 |
| Overall Study | Randomization error | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Site Closed | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Sponsor Request | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Subject Moved | 1 | 1 | 0 | 0 | 0 |
| Overall Study | Subject Withdrawal | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Unsatisfactory Subject Compliance | 1 | 2 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 3 | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | Rotigotine 2 mg/24 hr | Rotigotine 4 mg/24 hr | Rotigotine 6 mg/24 hr | Rotigotine 8 mg/24 hr | Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 55 Participants | 53 Participants | 57 Participants | 45 Participants | 60 Participants | 270 Participants |
| Age, Categorical Between 18 and 65 years | 46 Participants | 54 Participants | 47 Participants | 49 Participants | 48 Participants | 244 Participants |
| Age, Continuous | 65.4 years STANDARD_DEVIATION 10.5 | 64.6 years STANDARD_DEVIATION 9 | 64.6 years STANDARD_DEVIATION 10.4 | 63.2 years STANDARD_DEVIATION 11.6 | 64.8 years STANDARD_DEVIATION 10.2 | 64.5 years STANDARD_DEVIATION 10.3 |
| Region of Enrollment Chile | 2 participants | 2 participants | 1 participants | 2 participants | 2 participants | 9 participants |
| Region of Enrollment India | 28 participants | 29 participants | 31 participants | 29 participants | 33 participants | 150 participants |
| Region of Enrollment Mexico | 1 participants | 1 participants | 2 participants | 0 participants | 1 participants | 5 participants |
| Region of Enrollment Peru | 4 participants | 3 participants | 2 participants | 4 participants | 3 participants | 16 participants |
| Region of Enrollment United States | 66 participants | 72 participants | 68 participants | 59 participants | 69 participants | 334 participants |
| Sex: Female, Male Female | 24 Participants | 28 Participants | 31 Participants | 38 Participants | 34 Participants | 155 Participants |
| Sex: Female, Male Male | 77 Participants | 79 Participants | 73 Participants | 56 Participants | 74 Participants | 359 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 54 / 101 | 54 / 107 | 49 / 104 | 52 / 94 | 54 / 108 |
| serious Total, serious adverse events | 4 / 101 | 3 / 107 | 2 / 104 | 0 / 94 | 5 / 108 |
Outcome results
Primary
The Change in the Absolute Time Spent Off From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary
Time Off is defined as when the patient does not have the effect of anti-Parkinson's medication.
Time frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Population: Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine 2 mg/24 hr | The Change in the Absolute Time Spent Off From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | -1.948 Hours | Standard Deviation 2.587 |
| Rotigotine 4 mg/24 hr | The Change in the Absolute Time Spent Off From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | -2.052 Hours | Standard Deviation 3.113 |
| Rotigotine 6 mg/24 hr | The Change in the Absolute Time Spent Off From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | -2.138 Hours | Standard Deviation 2.721 |
| Rotigotine 8 mg/24 hr | The Change in the Absolute Time Spent Off From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | -2.360 Hours | Standard Deviation 2.608 |
| Placebo | The Change in the Absolute Time Spent Off From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | -1.499 Hours | Standard Deviation 3.062 |
Secondary
The Change in Number of Off Periods From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary
Time Off is defined as when the patient does not have the effect of anti-Parkinson's medication.
Time frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Population: Of the 502 subjects in the Full Analysis Set (FAS), 405 are included in this analysis. The Observed Cases (OC) method was utilized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine 2 mg/24 hr | The Change in Number of Off Periods From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | -1.144 Hours | Standard Deviation 1.687 |
| Rotigotine 4 mg/24 hr | The Change in Number of Off Periods From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | -1.294 Hours | Standard Deviation 1.971 |
| Rotigotine 6 mg/24 hr | The Change in Number of Off Periods From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | -1.323 Hours | Standard Deviation 1.348 |
| Rotigotine 8 mg/24 hr | The Change in Number of Off Periods From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | -1.304 Hours | Standard Deviation 1.442 |
| Placebo | The Change in Number of Off Periods From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | -1.006 Hours | Standard Deviation 1.474 |
Secondary
The Change in Relative Time Spent Off From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary
Time Off is defined as when the patient does not have the effect of anti-Parkinson's medication.
Time frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Population: Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine 2 mg/24 hr | The Change in Relative Time Spent Off From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | -12.058 Hours | Standard Deviation 16.517 |
| Rotigotine 4 mg/24 hr | The Change in Relative Time Spent Off From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | -13.463 Hours | Standard Deviation 20.099 |
| Rotigotine 6 mg/24 hr | The Change in Relative Time Spent Off From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | -13.410 Hours | Standard Deviation 17.202 |
| Rotigotine 8 mg/24 hr | The Change in Relative Time Spent Off From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | -14.529 Hours | Standard Deviation 16.531 |
| Placebo | The Change in Relative Time Spent Off From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | -9.250 Hours | Standard Deviation 18.942 |
Secondary
The Change in the Absolute Time Spent on From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary
Time On is defined as when the patient has the effect of anti-Parkinson's medication.
Time frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Population: Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward method was utilized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine 2 mg/24 hr | The Change in the Absolute Time Spent on From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | 1.821 Hours | Standard Deviation 2.655 |
| Rotigotine 4 mg/24 hr | The Change in the Absolute Time Spent on From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | 2.095 Hours | Standard Deviation 3.12 |
| Rotigotine 6 mg/24 hr | The Change in the Absolute Time Spent on From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | 2.118 Hours | Standard Deviation 2.827 |
| Rotigotine 8 mg/24 hr | The Change in the Absolute Time Spent on From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | 2.364 Hours | Standard Deviation 2.876 |
| Placebo | The Change in the Absolute Time Spent on From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | 1.335 Hours | Standard Deviation 2.975 |
Secondary
The Change in the Relative Time Spent on From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary
Time On is defined as when the patient has the effect of anti-Parkinson's medication.
Time frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Population: Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine 2 mg/24 hr | The Change in the Relative Time Spent on From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | 12.058 Hours | Standard Deviation 16.517 |
| Rotigotine 4 mg/24 hr | The Change in the Relative Time Spent on From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | 13.463 Hours | Standard Deviation 20.099 |
| Rotigotine 6 mg/24 hr | The Change in the Relative Time Spent on From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | 13.410 Hours | Standard Deviation 17.202 |
| Rotigotine 8 mg/24 hr | The Change in the Relative Time Spent on From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | 14.529 Hours | Standard Deviation 16.531 |
| Placebo | The Change in the Relative Time Spent on From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | 9.250 Hours | Standard Deviation 18.942 |
Secondary
The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary
Time frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Population: Of the 502 subjects in the Full Analysis Set (FAS), 405 are included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rotigotine 2 mg/24 hr | The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | ON Without Troublesome Dyskinesias | 23.688 Hours | Standard Deviation 41.607 |
| Rotigotine 2 mg/24 hr | The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | ON With Troublesome Dyskinesias | -0.667 Hours | Standard Deviation 18.874 |
| Rotigotine 2 mg/24 hr | The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | OFF | -23.021 Hours | Standard Deviation 40.667 |
| Rotigotine 4 mg/24 hr | The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | OFF | -23.780 Hours | Standard Deviation 43.15 |
| Rotigotine 4 mg/24 hr | The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | ON Without Troublesome Dyskinesias | 24.593 Hours | Standard Deviation 43.006 |
| Rotigotine 4 mg/24 hr | The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | ON With Troublesome Dyskinesias | -0.813 Hours | Standard Deviation 12.804 |
| Rotigotine 6 mg/24 hr | The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | ON Without Troublesome Dyskinesias | 20.935 Hours | Standard Deviation 42.132 |
| Rotigotine 6 mg/24 hr | The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | ON With Troublesome Dyskinesias | 1.626 Hours | Standard Deviation 23.659 |
| Rotigotine 6 mg/24 hr | The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | OFF | -22.561 Hours | Standard Deviation 40.519 |
| Rotigotine 8 mg/24 hr | The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | ON Without Troublesome Dyskinesias | 21.083 Hours | Standard Deviation 45.642 |
| Rotigotine 8 mg/24 hr | The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | ON With Troublesome Dyskinesias | 1.667 Hours | Standard Deviation 13.417 |
| Rotigotine 8 mg/24 hr | The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | OFF | -22.750 Hours | Standard Deviation 47.193 |
| Placebo | The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | ON Without Troublesome Dyskinesias | 19.712 Hours | Standard Deviation 41.857 |
| Placebo | The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | OFF | -19.506 Hours | Standard Deviation 43.298 |
| Placebo | The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary | ON With Troublesome Dyskinesias | -0.206 Hours | Standard Deviation 8.934 |
Secondary
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II From Baseline to the End of the Maintenance Period
The Unified Parkinson's Disease Rating Scale (UPDRS) Part II is a scale for the assessment of function in Parkinson's disease. UPDRS Part II measures Activities of Daily Living. It consists of 13 questions, each ranging from 0 to 4. The sum score of the UPDRS Part II ranges from 0 to 52. A higher score indicates greater disability. A negative change score indicates improvement.
Time frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Population: Of the 502 subjects in the Full Analysis Set (FAS), 497 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II From Baseline to the End of the Maintenance Period | -2.1 units on a scale | Standard Deviation 4.3 |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II From Baseline to the End of the Maintenance Period | -2.2 units on a scale | Standard Deviation 3.9 |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II From Baseline to the End of the Maintenance Period | -1.5 units on a scale | Standard Deviation 4.7 |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II From Baseline to the End of the Maintenance Period | -2.1 units on a scale | Standard Deviation 4.6 |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II From Baseline to the End of the Maintenance Period | -0.9 units on a scale | Standard Deviation 3.7 |
Secondary
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III From Baseline to the End of the Maintenance Period
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 score indicates improvement.
Time frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Population: Of the 502 subjects in the Full Analysis Set (FAS), 496 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III From Baseline to the End of the Maintenance Period | -3.4 units on a scale | Standard Deviation 7.6 |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III From Baseline to the End of the Maintenance Period | -4.5 units on a scale | Standard Deviation 7.5 |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III From Baseline to the End of the Maintenance Period | -3.5 units on a scale | Standard Deviation 8.9 |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III From Baseline to the End of the Maintenance Period | -5.9 units on a scale | Standard Deviation 7.6 |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III From Baseline to the End of the Maintenance Period | -2.5 units on a scale | Standard Deviation 8.2 |
Secondary
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Predictable?
Item = Are off periods predictable (question #36) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates off periods are predictable. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
Time frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Population: Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Predictable? | Equal | 80 participants |
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Predictable? | Worsening | 6 participants |
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Predictable? | Improvement | 11 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Predictable? | Equal | 82 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Predictable? | Worsening | 4 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Predictable? | Improvement | 15 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Predictable? | Equal | 74 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Predictable? | Worsening | 12 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Predictable? | Improvement | 12 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Predictable? | Worsening | 3 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Predictable? | Improvement | 11 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Predictable? | Equal | 80 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Predictable? | Equal | 85 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Predictable? | Worsening | 11 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Predictable? | Improvement | 9 participants |
Secondary
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Unpredictable?
Item = Are off periods unpredictable (question #37) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates off periods are unpredictable. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
Time frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Population: Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Unpredictable? | Worsening | 15 participants |
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Unpredictable? | Improvement | 11 participants |
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Unpredictable? | Equal | 71 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Unpredictable? | Equal | 78 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Unpredictable? | Worsening | 12 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Unpredictable? | Improvement | 11 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Unpredictable? | Equal | 73 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Unpredictable? | Worsening | 8 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Unpredictable? | Improvement | 17 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Unpredictable? | Worsening | 8 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Unpredictable? | Improvement | 11 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Unpredictable? | Equal | 75 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Unpredictable? | Equal | 77 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Unpredictable? | Worsening | 12 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are Off Periods Unpredictable? | Improvement | 16 participants |
Secondary
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias?
Item = Disability (question #33) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - How disabling are the dyskinesias? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
Time frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Population: Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias? | Improvement | 10 participants |
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias? | Equal | 80 participants |
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias? | Worsening | 7 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias? | Worsening | 6 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias? | Improvement | 6 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias? | Equal | 89 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias? | Improvement | 10 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias? | Worsening | 2 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias? | Equal | 86 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias? | Improvement | 10 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias? | Equal | 78 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias? | Worsening | 6 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias? | Worsening | 9 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias? | Improvement | 6 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias? | Equal | 90 participants |
Secondary
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting?
Item = Does the patient have anorexia, nausea, or vomiting (question #40) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has anorexia, nausea, or vomiting. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
Time frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Population: Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting? | Worsening | 4 participants |
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting? | Improvement | 5 participants |
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting? | Equal | 88 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting? | Equal | 96 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting? | Worsening | 2 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting? | Improvement | 3 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting? | Equal | 90 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting? | Worsening | 3 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting? | Improvement | 5 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting? | Worsening | 5 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting? | Improvement | 4 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting? | Equal | 85 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting? | Equal | 96 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting? | Worsening | 3 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting? | Improvement | 6 participants |
Secondary
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence?
Item = Does the patient have any sleep disturbances such as insomnia or hypersomnolence (question #41) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has sleep disturbances such as insomnia or hypersomnolence. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
Time frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Population: Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence? | Worsening | 13 participants |
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence? | Improvement | 14 participants |
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence? | Equal | 70 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence? | Equal | 72 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence? | Worsening | 14 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence? | Improvement | 15 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence? | Equal | 75 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence? | Worsening | 7 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence? | Improvement | 16 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence? | Worsening | 4 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence? | Improvement | 13 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence? | Equal | 77 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence? | Equal | 78 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence? | Worsening | 12 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence? | Improvement | 15 participants |
Secondary
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis?
Item = Does the patient have symptomatic orthostasis (question #42) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has symptomatic orthostasis. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
Time frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Population: Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis? | Worsening | 0 participants |
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis? | Equal | 91 participants |
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis? | Improvement | 6 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis? | Worsening | 6 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis? | Equal | 93 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis? | Improvement | 2 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis? | Improvement | 4 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis? | Equal | 92 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis? | Worsening | 2 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis? | Improvement | 2 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis? | Worsening | 4 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis? | Equal | 88 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis? | Improvement | 6 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis? | Worsening | 8 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis? | Equal | 91 participants |
Secondary
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do Off Periods Come on Suddenly?
Item = Do off periods come on suddenly, within a few seconds (question #38) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates off periods come on suddenly, within a few seconds. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
Time frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Population: Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do Off Periods Come on Suddenly? | Worsening | 6 participants |
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do Off Periods Come on Suddenly? | Improvement | 11 participants |
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do Off Periods Come on Suddenly? | Equal | 80 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do Off Periods Come on Suddenly? | Equal | 83 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do Off Periods Come on Suddenly? | Worsening | 7 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do Off Periods Come on Suddenly? | Improvement | 11 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do Off Periods Come on Suddenly? | Equal | 75 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do Off Periods Come on Suddenly? | Worsening | 11 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do Off Periods Come on Suddenly? | Improvement | 12 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do Off Periods Come on Suddenly? | Worsening | 9 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do Off Periods Come on Suddenly? | Improvement | 18 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do Off Periods Come on Suddenly? | Equal | 67 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do Off Periods Come on Suddenly? | Equal | 75 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do Off Periods Come on Suddenly? | Worsening | 15 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do Off Periods Come on Suddenly? | Improvement | 15 participants |
Secondary
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias?
Item = Painful Dyskinesia (question #34) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - How painful are the dyskinesias? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
Time frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Population: Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias? | Worsening | 2 participants |
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias? | Improvement | 5 participants |
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias? | Equal | 90 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias? | Equal | 94 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias? | Worsening | 3 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias? | Improvement | 4 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias? | Equal | 86 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias? | Worsening | 4 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias? | Improvement | 8 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias? | Worsening | 2 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias? | Improvement | 5 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias? | Equal | 87 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias? | Equal | 94 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias? | Worsening | 8 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias? | Improvement | 3 participants |
Secondary
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia
Item = Presence of Early Morning Dystonia (question #35) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates early morning dystonia. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
Time frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Population: Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia | Worsening | 5 participants |
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia | Improvement | 11 participants |
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia | Equal | 81 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia | Equal | 79 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia | Worsening | 9 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia | Improvement | 13 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia | Equal | 78 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia | Worsening | 7 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia | Improvement | 13 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia | Worsening | 6 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia | Improvement | 12 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia | Equal | 76 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia | Equal | 82 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia | Worsening | 14 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia | Improvement | 9 participants |
Secondary
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present?
Item = Duration (question #32) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - What proportion of the waking day are dyskinesias present? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
Time frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Population: Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present? | Improvement | 8 participants |
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present? | Equal | 74 participants |
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present? | Worsening | 15 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present? | Improvement | 15 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present? | Worsening | 14 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present? | Equal | 72 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present? | Improvement | 10 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present? | Equal | 75 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present? | Worsening | 13 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present? | Improvement | 10 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present? | Worsening | 15 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present? | Equal | 69 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present? | Worsening | 12 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present? | Improvement | 9 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present? | Equal | 84 participants |
Secondary
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject Off, on Average?
Item = What proportion of the waking day is the subject off, on average (question #39) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 - 4 points (4 = maximum). A higher score indicates the subject is off a larger portion of the waking day. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
Time frame: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Population: Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject Off, on Average? | Worsening | 8 participants |
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject Off, on Average? | Improvement | 37 participants |
| Rotigotine 2 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject Off, on Average? | Equal | 52 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject Off, on Average? | Equal | 58 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject Off, on Average? | Worsening | 4 participants |
| Rotigotine 4 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject Off, on Average? | Improvement | 39 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject Off, on Average? | Equal | 58 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject Off, on Average? | Worsening | 8 participants |
| Rotigotine 6 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject Off, on Average? | Improvement | 32 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject Off, on Average? | Worsening | 7 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject Off, on Average? | Improvement | 32 participants |
| Rotigotine 8 mg/24 hr | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject Off, on Average? | Equal | 55 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject Off, on Average? | Equal | 61 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject Off, on Average? | Worsening | 11 participants |
| Placebo | The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject Off, on Average? | Improvement | 33 participants |