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| Name | Class |
|---|---|
| PRA Health Sciences | INDUSTRY |
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This study aims to evaluate the effectiveness of Rotigotine and Levodopa combination therapy for younger and older patients with Parkinson's Disease under real life conditions. Effects on ability to perform activities of daily living, sleep, medication dose and other factors will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD Patients < 70 years of age | Patients with Parkinson's Disease (PD) <70 years of age. | ||
| PD Patients ≥ 70 years of age | Patients with Parkinson's Disease (PD) ≥ 70 years of age. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline to end of the Observational Period in Unified Parkinson's Disease Rating Scale Part II (UPDRS Part II) total score | The UPDRS Part II (Activities of Daily Living) consists of 13 items, each to be scored between 0 (normal/none) and 4 (highest level of severity). The sum score is calculated as the sum of the 13 individual scores (13 questions=52 points maximum; the higher the sum score, the greater degree of disability). | Baseline to end of Observational Period (6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline to end of the Observational Period in L-dopa dose | Baseline to end of Observational Period (6 months) | |
| Change from Baseline to end of the Observation Period in Parkinson's Disease Sleep Scale (PDSS-2) total score | The PDSS-2 is a 15 item scale that is used to assess sleep and nocturnal disability in Parkinson's Disease. It is designed for interviewer-administered completion or self-completion by patients. Patients are asked to rate how often during the past week he/she slept well or experienced various symptoms of sleep disability. Each of the 15 items are to be scored between 0 (never) to 4 (very often) with the total score ranging from 0 to 60; the higher the sum score, the greater the degree of impairment. |
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Inclusion Criteria:
The following selection criteria must be followed for patients entering the Noninterventional Study (NIS):
Exclusion Criteria:
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Patients with idiopathic Parkinson's Disease receiving levodopa as monotherapy or in combination with a dopamine agonist other than Rotigotine, but either not sufficiently controlled on or intolerant to current treatment, or other reason; patients are receiving treatment in general practitioner (GP) offices, private clinics or hospitals (including university hospitals) according to routine daily practice.
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 42 | Lille | France | ||||
| 41 |
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| Baseline to end of Observational Period (6 months) |
| Response at the end of the Observation Period defined as 20 % decrease in Unified Parkinson's Disease Rating Scale Part II (UPDRS Part II) total score | The UPDRS Part II (Activities of Daily Living) consists of 13 items, each to be scored between 0 (normal/none) and 4 (highest level of severity). The sum score is calculated as the sum of the 13 individual scores (13 questions = 52 points maximum); the higher the sum score, the greater degree of disability. | End of the Observation Period (Month 6) |
| Assessment at the end of the Observation Period in the score of the Clinical Global Impressions (CGI) Item 2 (Global Rating of Change of Condition) | CGI Item 2 (Global Rating of Change of Condition) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. Scores range from 0 to 7 as follows: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. | End of the Observation Period (Month 6) |
| Mougins |
| France |
| 40 | Nîmes | France |
| 6 | Alzenau in Unterfranken | Germany |
| 51 | Aschaffenburg | Germany |
| 13 | Beelitz-Heilstätten | Germany |
| 12 | Berlin | Germany |
| 5 | Böblingen | Germany |
| 53 | Düsseldorf | Germany |
| 7 | Erbach im Odenwald | Germany |
| 4 | Haag | Germany |
| 11 | Leer | Germany |
| 2 | Münster | Germany |
| 54 | Schriesheim | Germany |
| 8 | Senftenberg | Germany |
| 14 | Tübingen | Germany |
| 10 | Ulm | Germany |
| 3 | Westerstede | Germany |
| 45 | Ancona | Italy |
| 47 | Brescia | Italy |
| 60 | Cagliari | Italy |
| 29 | Cosenza | Italy |
| 30 | Florence | Italy |
| 46 | Milan | Italy |
| 27 | Naples | Italy |
| 28 | Roma | Italy |
| 62 | Roma | Italy |
| 20 | Barakaldo | Spain |
| 15 | Donostia / San Sebastian | Spain |
| 24 | Madrid | Spain |
| 22 | Palma de Mallorca | Spain |
| 37 | Bury | United Kingdom |
| 49 | Cambridge | United Kingdom |
| 52 | Lincoln | United Kingdom |
| 48 | Liverpool | United Kingdom |
| 33 | London | United Kingdom |
| 36 | London | United Kingdom |
| 34 | Manchester | United Kingdom |
| 31 | Middlesbrough | United Kingdom |
| 38 | North Shields | United Kingdom |
| 35 | Norwich | United Kingdom |
| 63 | Plymouth | United Kingdom |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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