Non-interventional, Retrospective, Multi-center Study to Evaluate Non-motor Symptoms in Advanced Parkinson Disease (PD) Patients Already Treated With Rotigotine (RETO-PD)

UCB

Status: Completed

Conditions: Parkinson's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01504529

UCB-ROT-2011-01

SP1018

Details and patient eligibility

About

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.

Enrollment: 391 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

391 participants in 1 patient group

Neupro Treatment

Description:

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.