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

April 12, 2013 updated by: UCB Pharma

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

391

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • A Coruña, Spain
        • 65
      • A Coruña, Spain
        • 66
      • A Coruña, Spain
        • 68
      • Albacete, Spain
        • 33
      • Alicante, Spain
        • 25
      • Alicante, Spain
        • 26
      • Alicante, Spain
        • 27
      • Avilés, Spain
        • 14
      • Baleares, Spain
        • 17
      • Barcelona, Spain
        • 42
      • Barcelona, Spain
        • 43
      • Barcelona, Spain
        • 44
      • Barcelona, Spain
        • 45
      • Barcelona, Spain
        • 47
      • Barcelona, Spain
        • 48
      • Barcelona, Spain
        • 49
      • Barcelona, Spain
        • 52
      • Barcelona, Spain
        • 85
      • Bilbao, Spain
        • 55
      • Cadiz, Spain
        • 10
      • Ciudad Real, Spain
        • 32
      • Cuenca, Spain
        • 34
      • Gerona, Spain
        • 53
      • Guipúzcoa, Spain
        • 59
      • Huesca, Spain
        • 11
      • Islas Baleares, Spain
        • 16
      • Jaen, Spain
        • 3
      • Jaen, Spain
        • 4
      • Lugo, Spain
        • 69
      • Lérida, Spain
        • 50
      • Madrid, Spain
        • 70
      • Madrid, Spain
        • 71
      • Madrid, Spain
        • 73
      • Madrid, Spain
        • 74
      • Madrid, Spain
        • 75
      • Madrid, Spain
        • 76
      • Madrid, Spain
        • 78
      • Madrid, Spain
        • 79
      • Madrid, Spain
        • 80
      • Mao, Spain
        • 18
      • Mieres, Spain
        • 15
      • Murcia, Spain
        • 81
      • Murcia, Spain
        • 82
      • Navarra, Spain
        • 83
      • Oviedo, Spain
        • 13
      • Pontevedra, Spain
        • 63
      • Pontevedra, Spain
        • 67
      • Santa Cruz de Tenerife, Spain
        • 30
      • Segovia, Spain
        • 38
      • Tenerife, Spain
        • 29
      • Tenerife, Spain
        • 31
      • Toledo, Spain
        • 36
      • Valencia, Spain
        • 19
      • Valencia, Spain
        • 20
      • Valencia, Spain
        • 22
      • Valencia, Spain
        • 23
      • Valencia, Spain
        • 24
      • Vera de Bidasoa, Spain
        • 58
      • Vizcaya, Spain
        • 56

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Neupro Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome 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)
Time Frame: From Baseline to Month 6
From Baseline to Month 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline to Month 6 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III
Time Frame: From Baseline to Month 6
From Baseline to Month 6
Change from Baseline to Month 6 in Hoehn & Yahr stage
Time Frame: From Baseline to Month 6
From Baseline to Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Collaborators

Pivotal S.L.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 3, 2012

First Submitted That Met QC Criteria

January 4, 2012

First Posted (Estimate)

January 5, 2012

Study Record Updates

Last Update Posted (Estimate)

April 15, 2013

Last Update Submitted That Met QC Criteria

April 12, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP1018
  • UCB-ROT-2011-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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