Idiopathic Parkinson Disease
Conditions
Keywords
Rotigotine, Neupro
Brief summary
This study will be conducted in an observational multiple-cohort design aimed at acquiring clinical, treatment, health status, and economic data. Patients with Parkinson's disease (PD) will be enrolled.
Detailed description
All patients attending the physician and fulfilling the eligibility criteria are included.
Interventions
None listed
Sponsors
UCB Pharma
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with idiopathic early-stage Parkinson's Disease requiring dopaminergic monotherapy (rotigotine, other dopamine agonists or levodopa) at study onset * Patients with advanced-stage Parkinson's Disease requiring dopaminergic therapy with levodopa in combination with rotigotine or other dopamine agonists at study onset
Exclusion criteria
* Patients who are unable to comply with study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | From Baseline to 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33) | From Baseline to 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). |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33) | 33 months | 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). |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33) | From Baseline to 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). |
| Hoehn & Yahr Stage at Visit 7 (Month 33) | 33 months | 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 |
| Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months) | 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. |
| Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33) | 33 months | 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. |
Countries
Czechia, Denmark, Germany, Greece, Italy, Mexico, Romania, Slovakia, Spain, Switzerland
Participant flow
Recruitment details
The study started to enroll subjects in June 2006. Overall, 2195 patients were enrolled in this study (Enrolled Set \[ES\]), of which 2179 were treated with rotigotine or another Parkinson's disease treatment according to the study protocol at least once (Safety Set \[SS\]).
Pre-assignment details
There were 36 patients without valid data consent. Therefore only Safety data were analyzed for these 36 patients. Patients without valid data consent or an unknown study termination status were neither considered as completer nor as non-completer in the Clinical Study Report. These patients are considered as non-completers in the summary below.
Participants by arm
| Arm | Count |
|---|---|
| Overall For this study, 5 groups of patients with different Parkinson's disease treatments were to be considered. Initial treatments were to include dopaminergic monotherapy with rotigotine, other dopamine agonists (eg, pramipexole, cabergoline, ropinirole), or L-dopa, treatment with L-dopa combined with rotigotine or other dopamine agonists. Treatment was to be performed according to standard medical practice. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. | 2,159 |
| Total | 2,159 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 79 |
| Overall Study | Lost to Follow-up | 221 |
| Overall Study | No valid data consent | 36 |
| Overall Study | Other Reason | 179 |
| Overall Study | Study Termination Status Unknown | 12 |
| Overall Study | Withdrawal by Subject | 137 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1435 Participants |
| Age, Categorical Between 18 and 65 years | 724 Participants |
| Age, Continuous | 67.7 years STANDARD_DEVIATION 9.4 |
| Sex: Female, Male Female | 956 Participants |
| Sex: Female, Male Male | 1203 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 237 / 1,390 | 245 / 1,328 |
| serious Total, serious adverse events | 261 / 1,390 | 269 / 1,328 |
Outcome results
Primary
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).
Time frame: From Baseline to Visit 7 (Month 33)
Population: All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro Monotherapy (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | -2.5 units on a scale | Standard Deviation 14.7 |
| Neupro Monotherapy (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | -2.5 units on a scale | Standard Deviation 10.3 |
| Other Dopamine Agonist (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | -2.2 units on a scale | Standard Deviation 11.1 |
| Other Dopamine Agonist (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | -5.6 units on a scale | Standard Deviation 16.9 |
| L-Dopa Monotherapy (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | 0.2 units on a scale | Standard Deviation 13.2 |
| L-Dopa Monotherapy (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | 0.0 units on a scale | Standard Deviation 12.2 |
| Multiple Dopamine Agonists (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | -1.2 units on a scale | Standard Deviation 13.8 |
| Multiple Dopamine Agonists (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | 3.5 units on a scale | Standard Deviation 6.4 |
| Neupro + L-Dopa (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | -1.2 units on a scale | Standard Deviation 14.2 |
| Neupro + L-Dopa (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | -1.5 units on a scale | Standard Deviation 17.5 |
| Other Dopamine Agonist + L-Dopa (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | -2.5 units on a scale | Standard Deviation 13.9 |
| Other Dopamine Agonist + L-Dopa (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | 8.6 units on a scale | Standard Deviation 13.5 |
| Multiple Dopamine Agonists + L-Dopa (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | 1.5 units on a scale | Standard Deviation 14.7 |
| Multiple Dopamine Agonists + L-Dopa (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | 20.0 units on a scale | Standard Deviation 29.7 |
| Not Treated (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | -3.2 units on a scale | Standard Deviation 10.8 |
| Not Treated (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | 4.1 units on a scale | Standard Deviation 15 |
Secondary
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.
Time frame: 33 months
Population: All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro Monotherapy (>= 3 Months) | Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33) | -0.27 units on a scale | Standard Deviation 1.79 |
| Neupro Monotherapy (< 3 Months) | Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33) | 1.36 units on a scale | Standard Deviation 3.51 |
| Other Dopamine Agonist (>= 3 Months) | Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33) | -0.15 units on a scale | Standard Deviation 1.48 |
| Other Dopamine Agonist (< 3 Months) | Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33) | 0.05 units on a scale | Standard Deviation 2.53 |
| L-Dopa Monotherapy (>= 3 Months) | Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33) | -0.09 units on a scale | Standard Deviation 1.84 |
| L-Dopa Monotherapy (< 3 Months) | Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33) | -0.26 units on a scale | Standard Deviation 2.3 |
| Multiple Dopamine Agonists (>= 3 Months) | Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33) | -0.73 units on a scale | Standard Deviation 1.49 |
| Multiple Dopamine Agonists (< 3 Months) | Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33) | 0.75 units on a scale | Standard Deviation 1.06 |
| Neupro + L-Dopa (>= 3 Months) | Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33) | -0.03 units on a scale | Standard Deviation 2.06 |
| Neupro + L-Dopa (< 3 Months) | Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33) | -0.42 units on a scale | Standard Deviation 2.01 |
| Other Dopamine Agonist + L-Dopa (>= 3 Months) | Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33) | -0.03 units on a scale | Standard Deviation 2.07 |
| Other Dopamine Agonist + L-Dopa (< 3 Months) | Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33) | 1.05 units on a scale | Standard Deviation 1.39 |
| Multiple Dopamine Agonists + L-Dopa (>= 3 Months) | Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33) | -0.01 units on a scale | Standard Deviation 1.9 |
| Multiple Dopamine Agonists + L-Dopa (< 3 Months) | Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33) | 3.25 units on a scale | Standard Deviation 4.6 |
| Not Treated (>= 3 Months) | Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33) | -0.38 units on a scale | Standard Deviation 1.1 |
| Not Treated (< 3 Months) | Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33) | 0.22 units on a scale | Standard Deviation 2.19 |
Secondary
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).
Time frame: From Baseline to Visit 7 (Month 33)
Population: All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro Monotherapy (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33) | -0.1 units on a scale | Standard Deviation 0.7 |
| Neupro Monotherapy (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33) | -0.2 units on a scale | Standard Deviation 0.6 |
| Other Dopamine Agonist (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33) | -0.1 units on a scale | Standard Deviation 0.5 |
| Other Dopamine Agonist (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33) | 0.0 units on a scale | Standard Deviation 0.8 |
| L-Dopa Monotherapy (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33) | 0.1 units on a scale | Standard Deviation 0.8 |
| L-Dopa Monotherapy (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33) | -0.1 units on a scale | Standard Deviation 0.5 |
| Multiple Dopamine Agonists (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33) | -0.1 units on a scale | Standard Deviation 0.5 |
| Multiple Dopamine Agonists (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33) | 0.0 units on a scale | Standard Deviation 0 |
| Neupro + L-Dopa (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33) | 0.1 units on a scale | Standard Deviation 0.7 |
| Neupro + L-Dopa (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33) | 0.2 units on a scale | Standard Deviation 1 |
| Other Dopamine Agonist + L-Dopa (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33) | 0.2 units on a scale | Standard Deviation 0.7 |
| Other Dopamine Agonist + L-Dopa (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33) | 0.2 units on a scale | Standard Deviation 0.6 |
| Multiple Dopamine Agonists + L-Dopa (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33) | 0.2 units on a scale | Standard Deviation 0.7 |
| Multiple Dopamine Agonists + L-Dopa (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33) | 0.5 units on a scale | Standard Deviation 0.7 |
| Not Treated (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33) | -0.2 units on a scale | Standard Deviation 0.4 |
| Not Treated (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33) | 0.1 units on a scale | Standard Deviation 0.8 |
Secondary
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).
Time frame: From Baseline to Visit 7 (Month 33)
Population: All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro Monotherapy (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33) | -0.1 units on a scale | Standard Deviation 0.7 |
| Neupro Monotherapy (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33) | -0.2 units on a scale | Standard Deviation 0.4 |
| Other Dopamine Agonist (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33) | -0.1 units on a scale | Standard Deviation 0.4 |
| Other Dopamine Agonist (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33) | -0.1 units on a scale | Standard Deviation 0.7 |
| L-Dopa Monotherapy (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33) | 0.0 units on a scale | Standard Deviation 0.8 |
| L-Dopa Monotherapy (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33) | -0.0 units on a scale | Standard Deviation 0.7 |
| Multiple Dopamine Agonists (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33) | -0.1 units on a scale | Standard Deviation 0.6 |
| Multiple Dopamine Agonists (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33) | 0.0 units on a scale | Standard Deviation 0 |
| Neupro + L-Dopa (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33) | 0.0 units on a scale | Standard Deviation 0.7 |
| Neupro + L-Dopa (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33) | 0.0 units on a scale | Standard Deviation 0.6 |
| Other Dopamine Agonist + L-Dopa (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33) | 0.1 units on a scale | Standard Deviation 0.7 |
| Other Dopamine Agonist + L-Dopa (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33) | -0.1 units on a scale | Standard Deviation 0.7 |
| Multiple Dopamine Agonists + L-Dopa (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33) | 0.2 units on a scale | Standard Deviation 0.8 |
| Multiple Dopamine Agonists + L-Dopa (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33) | 0.0 units on a scale | Standard Deviation 0 |
| Not Treated (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33) | -0.1 units on a scale | Standard Deviation 0.3 |
| Not Treated (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33) | 0.2 units on a scale | Standard Deviation 0.6 |
Secondary
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).
Time frame: 33 months
Population: All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neupro Monotherapy (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33) | -0.2 units on a scale | Standard Deviation 0.9 |
| Neupro Monotherapy (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33) | 0.5 units on a scale | Standard Deviation 0.9 |
| Other Dopamine Agonist (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33) | -0.1 units on a scale | Standard Deviation 0.8 |
| Other Dopamine Agonist (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33) | 0.1 units on a scale | Standard Deviation 0.9 |
| L-Dopa Monotherapy (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33) | 0.1 units on a scale | Standard Deviation 0.9 |
| L-Dopa Monotherapy (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33) | 0.1 units on a scale | Standard Deviation 1.1 |
| Multiple Dopamine Agonists (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33) | -0.4 units on a scale | Standard Deviation 0.9 |
| Multiple Dopamine Agonists (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33) | 0.0 units on a scale | Standard Deviation 0 |
| Neupro + L-Dopa (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33) | 0.0 units on a scale | Standard Deviation 0.8 |
| Neupro + L-Dopa (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33) | 0.0 units on a scale | Standard Deviation 0 |
| Other Dopamine Agonist + L-Dopa (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33) | 0.2 units on a scale | Standard Deviation 0.9 |
| Other Dopamine Agonist + L-Dopa (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33) | 0.2 units on a scale | Standard Deviation 0.9 |
| Multiple Dopamine Agonists + L-Dopa (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33) | -0.0 units on a scale | Standard Deviation 1 |
| Multiple Dopamine Agonists + L-Dopa (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33) | 1.5 units on a scale | Standard Deviation 2.1 |
| Not Treated (>= 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33) | 0.0 units on a scale | Standard Deviation 0.4 |
| Not Treated (< 3 Months) | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33) | 0.3 units on a scale | Standard Deviation 0.9 |
Secondary
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
Time frame: 33 months
Population: All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neupro Monotherapy (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 1 | 55 participants |
| Neupro Monotherapy (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 2 | 112 participants |
| Neupro Monotherapy (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 3 | 28 participants |
| Neupro Monotherapy (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 4 | 8 participants |
| Neupro Monotherapy (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 5 | 1 participants |
| Neupro Monotherapy (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 0 | 2 participants |
| Neupro Monotherapy (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | No Data/Missing | 1 participants |
| Neupro Monotherapy (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | No Data/Missing | 0 participants |
| Neupro Monotherapy (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 5 | 0 participants |
| Neupro Monotherapy (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 1 | 1 participants |
| Neupro Monotherapy (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 0 | 0 participants |
| Neupro Monotherapy (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 3 | 4 participants |
| Neupro Monotherapy (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 2 | 4 participants |
| Neupro Monotherapy (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 4 | 2 participants |
| Other Dopamine Agonist (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 1 | 48 participants |
| Other Dopamine Agonist (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 3 | 19 participants |
| Other Dopamine Agonist (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 0 | 0 participants |
| Other Dopamine Agonist (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 4 | 2 participants |
| Other Dopamine Agonist (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | No Data/Missing | 1 participants |
| Other Dopamine Agonist (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 5 | 0 participants |
| Other Dopamine Agonist (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 2 | 76 participants |
| Other Dopamine Agonist (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 5 | 0 participants |
| Other Dopamine Agonist (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 1 | 0 participants |
| Other Dopamine Agonist (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 4 | 0 participants |
| Other Dopamine Agonist (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | No Data/Missing | 1 participants |
| Other Dopamine Agonist (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 0 | 0 participants |
| Other Dopamine Agonist (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 2 | 6 participants |
| Other Dopamine Agonist (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 3 | 4 participants |
| L-Dopa Monotherapy (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | No Data/Missing | 0 participants |
| L-Dopa Monotherapy (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 2 | 118 participants |
| L-Dopa Monotherapy (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 1 | 29 participants |
| L-Dopa Monotherapy (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 4 | 14 participants |
| L-Dopa Monotherapy (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 3 | 70 participants |
| L-Dopa Monotherapy (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 5 | 3 participants |
| L-Dopa Monotherapy (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 0 | 0 participants |
| L-Dopa Monotherapy (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 5 | 0 participants |
| L-Dopa Monotherapy (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 4 | 2 participants |
| L-Dopa Monotherapy (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 2 | 12 participants |
| L-Dopa Monotherapy (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 3 | 8 participants |
| L-Dopa Monotherapy (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 0 | 0 participants |
| L-Dopa Monotherapy (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 1 | 1 participants |
| L-Dopa Monotherapy (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | No Data/Missing | 0 participants |
| Multiple Dopamine Agonists (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 4 | 1 participants |
| Multiple Dopamine Agonists (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 0 | 0 participants |
| Multiple Dopamine Agonists (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 1 | 0 participants |
| Multiple Dopamine Agonists (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 2 | 7 participants |
| Multiple Dopamine Agonists (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 3 | 5 participants |
| Multiple Dopamine Agonists (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 5 | 0 participants |
| Multiple Dopamine Agonists (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | No Data/Missing | 0 participants |
| Multiple Dopamine Agonists (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | No Data/Missing | 0 participants |
| Multiple Dopamine Agonists (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 0 | 0 participants |
| Multiple Dopamine Agonists (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 3 | 0 participants |
| Multiple Dopamine Agonists (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 1 | 1 participants |
| Multiple Dopamine Agonists (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 2 | 1 participants |
| Multiple Dopamine Agonists (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 4 | 0 participants |
| Multiple Dopamine Agonists (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 5 | 0 participants |
| Neupro + L-Dopa (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 0 | 2 participants |
| Neupro + L-Dopa (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 5 | 6 participants |
| Neupro + L-Dopa (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 1 | 29 participants |
| Neupro + L-Dopa (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | No Data/Missing | 1 participants |
| Neupro + L-Dopa (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 3 | 131 participants |
| Neupro + L-Dopa (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 4 | 46 participants |
| Neupro + L-Dopa (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 2 | 186 participants |
| Neupro + L-Dopa (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 2 | 2 participants |
| Neupro + L-Dopa (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 4 | 0 participants |
| Neupro + L-Dopa (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 3 | 2 participants |
| Neupro + L-Dopa (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | No Data/Missing | 0 participants |
| Neupro + L-Dopa (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 0 | 0 participants |
| Neupro + L-Dopa (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 5 | 0 participants |
| Neupro + L-Dopa (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 1 | 2 participants |
| Other Dopamine Agonist + L-Dopa (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 0 | 1 participants |
| Other Dopamine Agonist + L-Dopa (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 2 | 192 participants |
| Other Dopamine Agonist + L-Dopa (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 3 | 119 participants |
| Other Dopamine Agonist + L-Dopa (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 1 | 37 participants |
| Other Dopamine Agonist + L-Dopa (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 4 | 24 participants |
| Other Dopamine Agonist + L-Dopa (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 5 | 4 participants |
| Other Dopamine Agonist + L-Dopa (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | No Data/Missing | 1 participants |
| Other Dopamine Agonist + L-Dopa (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 1 | 0 participants |
| Other Dopamine Agonist + L-Dopa (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 2 | 2 participants |
| Other Dopamine Agonist + L-Dopa (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | No Data/Missing | 0 participants |
| Other Dopamine Agonist + L-Dopa (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 4 | 4 participants |
| Other Dopamine Agonist + L-Dopa (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 3 | 4 participants |
| Other Dopamine Agonist + L-Dopa (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 0 | 0 participants |
| Other Dopamine Agonist + L-Dopa (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 5 | 1 participants |
| Multiple Dopamine Agonists + L-Dopa (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 2 | 15 participants |
| Multiple Dopamine Agonists + L-Dopa (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 5 | 2 participants |
| Multiple Dopamine Agonists + L-Dopa (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 1 | 2 participants |
| Multiple Dopamine Agonists + L-Dopa (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | No Data/Missing | 1 participants |
| Multiple Dopamine Agonists + L-Dopa (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 4 | 3 participants |
| Multiple Dopamine Agonists + L-Dopa (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 0 | 0 participants |
| Multiple Dopamine Agonists + L-Dopa (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 3 | 13 participants |
| Multiple Dopamine Agonists + L-Dopa (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 4 | 1 participants |
| Multiple Dopamine Agonists + L-Dopa (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 0 | 0 participants |
| Multiple Dopamine Agonists + L-Dopa (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 1 | 0 participants |
| Multiple Dopamine Agonists + L-Dopa (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 5 | 0 participants |
| Multiple Dopamine Agonists + L-Dopa (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | No Data/Missing | 0 participants |
| Multiple Dopamine Agonists + L-Dopa (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 3 | 0 participants |
| Multiple Dopamine Agonists + L-Dopa (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 2 | 1 participants |
| Not Treated (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 3 | 1 participants |
| Not Treated (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 1 | 4 participants |
| Not Treated (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 4 | 1 participants |
| Not Treated (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | No Data/Missing | 0 participants |
| Not Treated (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 0 | 0 participants |
| Not Treated (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 5 | 0 participants |
| Not Treated (>= 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 2 | 7 participants |
| Not Treated (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 2 | 19 participants |
| Not Treated (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 3 | 11 participants |
| Not Treated (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 0 | 0 participants |
| Not Treated (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 4 | 3 participants |
| Not Treated (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | No Data/Missing | 0 participants |
| Not Treated (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 5 | 1 participants |
| Not Treated (< 3 Months) | Hoehn & Yahr Stage at Visit 7 (Month 33) | 1 | 3 participants |
Secondary
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.
Time frame: 33 months
Population: For analysis of Safety the patients in the Safety Set were sub-grouped into patients at risk developing an Adverse Event (AE) associated with rotigotine and patients at risk developing an AE not associated with rotigotine. This sub-grouping is non-disjunctive in nature, i.e. one patient might fall into both subgroups.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neupro Monotherapy (>= 3 Months) | Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months) | Cardiac valve sclerosis | 0 Adverse Events |
| Neupro Monotherapy (>= 3 Months) | Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months) | Cardiac valve disease | 1 Adverse Events |
| Neupro Monotherapy (>= 3 Months) | Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months) | Aortic valve sclerosis | 1 Adverse Events |
| Neupro Monotherapy (< 3 Months) | Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months) | Cardiac valve disease | 1 Adverse Events |
| Neupro Monotherapy (< 3 Months) | Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months) | Cardiac valve sclerosis | 2 Adverse Events |
| Neupro Monotherapy (< 3 Months) | Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months) | Aortic valve sclerosis | 0 Adverse Events |