Status:
COMPLETED
Non-interventional, Retrospective, Multi-center Study to Evaluate Non-motor Symptoms in Advanced Parkinson Disease (PD) Patients Already Treated With Rotigotine
Lead Sponsor:
UCB Pharma
Collaborating Sponsors:
Pivotal S.L.
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
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 clinica...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
391 Patients enrolled
Trial Details
Trial ID
NCT01504529
Start Date
September 1 2011
End Date
December 1 2012
Last Update
April 15 2013
Active Locations (59)
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A Coruña, Spain
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A Coruña, Spain
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A Coruña, Spain
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Albacete, Spain