Evaluating the Effectiveness of Neupro® (Rotigotine) and L-dopa Combination Therapy in Patients With Parkinson's Disease
NEUPART
A Multi-center Noninterventional Study to Evaluate the Effectiveness of Neupro® (Rotigotine Transdermal Patch) and Levodopa Combination Therapy in Patients With Parkinson's Disease (NEUPART)
1 other identifier
observational
195
5 countries
42
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2014
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2014
CompletedFirst Posted
Study publicly available on registry
August 28, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJuly 4, 2016
July 1, 2016
1.8 years
August 26, 2014
July 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (4)
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
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
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)
End of the Observation Period (Month 6)
Study Arms (2)
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.
Eligibility Criteria
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.
You may qualify if:
- The following selection criteria must be followed for patients entering the Noninterventional Study (NIS):
- The decision by the treating physician to prescribe Rotigotine transdermal patch is made before participating in the NIS due to a clinical therapeutic indication (e.g., because of intolerance and/or ineffectiveness of another dopamine agonist)
- The patient is either male or female and over 18 years of age
- A Patient Data Consent form is signed and dated by the patient or by the legal representative
- The patient has idiopathic Parkinson's Disease, has not received Rotigotine within 28 days prior to the Baseline Visit and is willing to participate in questionnaire based assessments
- The patient is receiving L-dopa as monotherapy or a combination therapy composed of L-dopa and a dopamine agonist other than Rotigotine
- The patient has been on L-dopa therapy for at least 6 months and is responding to initial L-dopa therapy
- The patient has a Hoehn and Yahr stage score of 1 to 4.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Biopharma S.P.R.L.lead
- PRA Health Sciencescollaborator
Study Sites (42)
42
Lille, France
41
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
Napoli, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2014
First Posted
August 28, 2014
Study Start
September 1, 2014
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
July 4, 2016
Record last verified: 2016-07