Clinical trial NCT01504529: Non-interventional, Retrospective, Multi-center Study to Evaluate Non-motor Symptoms in Advanced Parkinson Disease (PD) Patients Already Treated With Rotigotine
Official title: Non-Interventional, Retrospective, Multi-center Study to Evaluate Non-Motor Symptoms in Advanced PD Patients Already Treated With Rotigotine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Rotigotine (Neupro)
Non-Motor Symptoms
Advanced Parkinson's Disease
Local study
Spain
Observational study
Non-interventional study
Retrospective study
Post-marketing study
Multicenter study
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: Pivotal S.L.
First posted: 2012-01-05
Enrollment: 391
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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)

Primary outcomes:
measure: Change from Baseline to Month 6 in Non-Motor Symptoms (NMS) as assessed by the Parkinson's Disease Non-Motor Symptoms Questionnaire (PDNMS-Q)
timeFrame: From Baseline to Month 6
Secondary outcomes:
measure: Change from Baseline to Month 6 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III
timeFrame: From Baseline to Month 6
measure: Change from Baseline to Month 6 in Hoehn & Yahr stage
timeFrame: From Baseline to Month 6
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: 65
city: A Coruña
country: Spain
facility: 66
city: A Coruña
country: Spain
facility: 68
city: Albacete
country: Spain
facility: 33
city: Alicante
country: Spain
facility: 25
city: Alicante
country: Spain
facility: 26
city: Alicante
country: Spain
facility: 27
city: Avilés
country: Spain
facility: 14
city: Baleares
country: Spain
facility: 17
city: Barcelona
country: Spain
facility: 42
city: Barcelona
country: Spain
facility: 43
city: Barcelona
country: Spain
facility: 44
city: Barcelona
country: Spain
facility: 45
city: Barcelona
country: Spain
facility: 47
city: Barcelona
country: Spain
facility: 48
city: Barcelona
country: Spain
facility: 49
city: Barcelona
country: Spain
facility: 52
city: Barcelona
country: Spain
facility: 85
city: Bilbao
country: Spain
facility: 55
city: Cadiz
country: Spain
facility: 10
city: Ciudad Real
country: Spain
facility: 32
city: Cuenca
country: Spain
facility: 34
city: Gerona
country: Spain
facility: 53
city: Guipúzcoa
country: Spain
facility: 59
city: Huesca
country: Spain
facility: 11
city: Islas Baleares
country: Spain
facility: 16
city: Jaen
country: Spain
facility: 3
city: Jaen
country: Spain
facility: 4
city: Lugo
country: Spain
facility: 69
city: Lérida
country: Spain
facility: 50
city: Madrid
country: Spain
facility: 70
city: Madrid
country: Spain
facility: 71
city: Madrid
country: Spain
facility: 73
city: Madrid
country: Spain
facility: 74
city: Madrid
country: Spain
facility: 75
city: Madrid
country: Spain
facility: 76
city: Madrid
country: Spain
facility: 78
city: Madrid
country: Spain
facility: 79
city: Madrid
country: Spain
facility: 80
city: Mao
country: Spain
facility: 18
city: Mieres
country: Spain
facility: 15
city: Murcia
country: Spain
facility: 81
city: Murcia
country: Spain
facility: 82
city: Navarra
country: Spain
facility: 83
city: Oviedo
country: Spain
facility: 13
city: Pontevedra
country: Spain
facility: 63
city: Pontevedra
country: Spain
facility: 67
city: Santa Cruz de Tenerife
country: Spain
facility: 30
city: Segovia
country: Spain
facility: 38
city: Tenerife
country: Spain
facility: 29
city: Tenerife
country: Spain
facility: 31
city: Toledo
country: Spain
facility: 36
city: Valencia
country: Spain
facility: 19
city: Valencia
country: Spain
facility: 20
city: Valencia
country: Spain
facility: 22
city: Valencia
country: Spain
facility: 23
city: Valencia
country: Spain
facility: 24
city: Vera de Bidasoa
country: Spain
facility: 58
city: Vizcaya
country: Spain
facility: 56
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.