Non-interventional, Retrospective, Multi-center Study to Evaluate Non-motor Symptoms in Advanced Parkinson Disease (PD) Patients Already Treated With Rotigotine
- Conditions
- Parkinson's Disease
- Registration Number
- NCT01504529
- Lead Sponsor
- UCB Pharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 391
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
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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (59)
45
🇪🇸Barcelona, Spain
52
🇪🇸Barcelona, Spain
14
🇪🇸Avilés, Spain
47
🇪🇸Barcelona, Spain
68
🇪🇸A Coruña, Spain
17
🇪🇸Baleares, Spain
18
🇪🇸Mao, Spain
38
🇪🇸Segovia, Spain
25
🇪🇸Alicante, Spain
33
🇪🇸Albacete, Spain
66
🇪🇸A Coruña, Spain
65
🇪🇸A Coruña, Spain
42
🇪🇸Barcelona, Spain
43
🇪🇸Barcelona, Spain
48
🇪🇸Barcelona, Spain
44
🇪🇸Barcelona, Spain
49
🇪🇸Barcelona, Spain
85
🇪🇸Barcelona, Spain
55
🇪🇸Bilbao, Spain
10
🇪🇸Cadiz, Spain
53
🇪🇸Gerona, Spain
34
🇪🇸Cuenca, Spain
11
🇪🇸Huesca, Spain
32
🇪🇸Ciudad Real, Spain
16
🇪🇸Islas Baleares, Spain
3
🇪🇸Jaen, Spain
59
🇪🇸Guipúzcoa, Spain
4
🇪🇸Jaen, Spain
69
🇪🇸Lugo, Spain
50
🇪🇸Lérida, Spain
70
🇪🇸Madrid, Spain
71
🇪🇸Madrid, Spain
73
🇪🇸Madrid, Spain
74
🇪🇸Madrid, Spain
76
🇪🇸Madrid, Spain
75
🇪🇸Madrid, Spain
78
🇪🇸Madrid, Spain
79
🇪🇸Madrid, Spain
80
🇪🇸Madrid, Spain
30
🇪🇸Santa Cruz de Tenerife, Spain
81
🇪🇸Murcia, Spain
67
🇪🇸Pontevedra, Spain
13
🇪🇸Oviedo, Spain
83
🇪🇸Navarra, Spain
63
🇪🇸Pontevedra, Spain
15
🇪🇸Mieres, Spain
82
🇪🇸Murcia, Spain
29
🇪🇸Tenerife, Spain
31
🇪🇸Tenerife, Spain
36
🇪🇸Toledo, Spain
20
🇪🇸Valencia, Spain
23
🇪🇸Valencia, Spain
19
🇪🇸Valencia, Spain
22
🇪🇸Valencia, Spain
56
🇪🇸Vizcaya, Spain
58
🇪🇸Vera de Bidasoa, Spain
24
🇪🇸Valencia, Spain
26
🇪🇸Alicante, Spain
27
🇪🇸Alicante, Spain