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

Non-Interventional, Retrospective, Multi-center Study to Evaluate Non-Motor Symptoms in Advanced PD Patients Already Treated With Rotigotine

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01504529

Acronym

RETO-PD

Enrollment

391

Registered

2012-01-05

Start date

2011-09-30

Completion date

2012-12-31

Last updated

2013-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Spain

Outcome results