Non-interventional, Retrospective, Multi-center Study to Evaluate Non-motor Symptoms in Advanced Parkinson Disease (PD) Patients Already Treated With Rotigotine
RETO-PD
Non-Interventional, Retrospective, Multi-center Study to Evaluate Non-Motor Symptoms in Advanced PD Patients Already Treated With Rotigotine
2 other identifiers
observational
391
1 country
59
Brief Summary
This is an observational, non-interventional and retrospective study in patients with advanced PD who have been treated with Rotigotine (Neupro®) as prescribed by physicians according to usual clinical practice in Spain. The Primary Objective will be to evaluate Non-Motor Symptoms (NMS) in advanced PD patients who have been treated with Rotigotine for at least 6 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2011
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 3, 2012
CompletedFirst Posted
Study publicly available on registry
January 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedApril 15, 2013
April 1, 2013
1.3 years
January 3, 2012
April 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline to Month 6 in Non-Motor Symptoms (NMS) as assessed by the Parkinson's Disease Non-Motor Symptoms Questionnaire (PDNMS-Q)
From Baseline to Month 6
Secondary Outcomes (2)
Change from Baseline to Month 6 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III
From Baseline to Month 6
Change from Baseline to Month 6 in Hoehn & Yahr stage
From Baseline to Month 6
Study Arms (1)
Neupro Treatment
Data from patients with advanced PD who have been treated with Rotigotine (Neupro®) for at least the previous 6 months as prescribed by physicians according to usual clinical practice in Spain, will be retrospectively collected.
Eligibility Criteria
As a retrospective Observational Study, the data will be obtained from the medical records of the patients with advanced PD who have been treated for at least 6 months with Rotigotine (Neupro®) as prescribed by physicians according to usual clinical practice in Spain. The study will approximately include 400 patients from 80 Spanish sites.
You may qualify if:
- To be eligible to participate in this study, all of the following criteria must be met:
- Male and female ambulatory patients with Parkinson's disease diagnosis (as per the London Brain Bank diagnosis criteria) ≥6 months ago
- Patient aged 30 years or older at the time of Parkinson's disease diagnosis
- Patients who were under treatment with Rotigotine following routine clinical practice, either alone or in combination with Levodopa, and in an advanced PD dosage (≥ 8 mg/ 24 h) for at least the previous 6 months
- Patients under treatment with Rotigotine (≥ 8 mg/ 24 h) who were assessed twice of NMS by means of the PDNMS-Q 6 months apart
- Patients are currently informed and have been given enough time and opportunity to think about participation (data collection) in the study and have given written informed consent
You may not qualify if:
- Patients are not permitted to enroll in the study if any of the following criteria is met during the previous 6 months:
- Patients have other Parkinsonian syndrome different than Parkinson´s disease
- Patients have a history of Pallidotomy, Thalamotomy, Deep Brain Stimulation or Fetal Tissue Transplant
- Patients with Dementia, active Hallucinations or active or treated Psychosis
- Patients with any other neurological / psychological disorder
- Patients who had received Central Nervous System (CNS) active therapy (e.g. sedatives, hypnotics, anti-depressants, anxiolytics, atypical neuroleptics, etc)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
- Pivotal S.L.collaborator
Study Sites (59)
65
A Coruña, Spain
66
A Coruña, Spain
68
A Coruña, Spain
33
Albacete, Spain
25
Alicante, Spain
26
Alicante, Spain
27
Alicante, Spain
14
Avilés, Spain
17
Baleares, Spain
42
Barcelona, Spain
43
Barcelona, Spain
44
Barcelona, Spain
45
Barcelona, Spain
47
Barcelona, Spain
48
Barcelona, Spain
49
Barcelona, Spain
52
Barcelona, Spain
85
Barcelona, Spain
58
Bera, Spain
55
Bilbao, Spain
10
Cadiz, Spain
32
Ciudad Real, Spain
34
Cuenca, Spain
53
Girona, Spain
59
Guipúzcoa, Spain
11
Huesca, Spain
16
Islas Baleares, Spain
3
Jaén, Spain
4
Jaén, Spain
50
Lleida, Spain
69
Lugo, Spain
70
Madrid, Spain
71
Madrid, Spain
73
Madrid, Spain
74
Madrid, Spain
75
Madrid, Spain
76
Madrid, Spain
78
Madrid, Spain
79
Madrid, Spain
80
Madrid, Spain
18
Maó, Spain
15
Mieres, Spain
81
Murcia, Spain
82
Murcia, Spain
83
Navarra, Spain
13
Oviedo, Spain
63
Pontevedra, Spain
67
Pontevedra, Spain
29
Santa Cruz de Tenerife, Spain
30
Santa Cruz de Tenerife, Spain
31
Santa Cruz de Tenerife, Spain
38
Segovia, Spain
36
Toledo, Spain
19
Valencia, Spain
20
Valencia, Spain
22
Valencia, Spain
23
Valencia, Spain
24
Valencia, Spain
56
Vizcaya, Spain
Related Publications (1)
Valldeoriola F, Salvador A, Gomez-Arguelles JM, Marey J, Moya M, Ayuga A, Ramirez F. The effects of transdermal rotigotine on non-motor symptoms of Parkinson's disease: a multicentre, observational, retrospective, post-marketing study. Int J Neurosci. 2018 Apr;128(4):369-375. doi: 10.1080/00207454.2017.1387111. Epub 2017 Dec 17.
PMID: 29249180DERIVED
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
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2012
First Posted
January 5, 2012
Study Start
September 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
April 15, 2013
Record last verified: 2013-04