Non-interventional, Retrospective, Multi-center Study to Evaluate Non-motor Symptoms in Advanced Parkinson Disease (PD) Patients Already Treated With Rotigotine
NCT ID: NCT01504529
Last Updated: 2013-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
391 participants
OBSERVATIONAL
2011-09-30
2012-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
30 Years
ALL
No
Sponsors
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Pivotal S.L.
INDUSTRY
UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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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
Mahon, , 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
Countries
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References
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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.
Other Identifiers
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UCB-ROT-2011-01
Identifier Type: -
Identifier Source: secondary_id
SP1018
Identifier Type: -
Identifier Source: org_study_id
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