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Parkinson's DiseaseRETO-PDNCT01504529

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

An observational study of Parkinson's Disease, run by UCB Pharma at 59 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Parkinson's Disease
How many people
391 participants
Where
59 sitesSpain
Study dates
Sep 2011to Dec 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

59 sites in 1 country.

59 sites in 1 country

Spain59 sites

  • 65

    A Coruña

  • 66

    A Coruña

  • 68

    A Coruña

  • 33

    Albacete

  • 25

    Alicante

  • 26

    Alicante

  • 27

    Alicante

  • 14

    Avilés

  • 17

    Baleares

  • 42

    Barcelona

  • 43

    Barcelona

  • 44

    Barcelona

  • 45

    Barcelona

  • 47

    Barcelona

  • 48

    Barcelona

  • 49

    Barcelona

  • 52

    Barcelona

  • 85

    Barcelona

  • 58

    Bera

  • 55

    Bilbao

  • 10

    Cadiz

  • 32

    Ciudad Real

  • 34

    Cuenca

  • 53

    Girona

  • 59

    Guipúzcoa

  • 11

    Huesca

  • 16

    Islas Baleares

  • 3

    Jaén

  • 4

    Jaén

  • 50

    Lleida

  • 69

    Lugo

  • 70

    Madrid

  • 71

    Madrid

  • 73

    Madrid

  • 74

    Madrid

  • 75

    Madrid

  • 76

    Madrid

  • 78

    Madrid

  • 79

    Madrid

  • 80

    Madrid

  • 18

    Maó

  • 15

    Mieres

  • 81

    Murcia

  • 82

    Murcia

  • 83

    Navarra

  • 13

    Oviedo

  • 63

    Pontevedra

  • 67

    Pontevedra

  • 29

    Santa Cruz de Tenerife

  • 30

    Santa Cruz de Tenerife

  • 31

    Santa Cruz de Tenerife

  • 38

    Segovia

  • 36

    Toledo

  • 19

    Valencia

  • 20

    Valencia

  • 22

    Valencia

  • 23

    Valencia

  • 24

    Valencia

  • 56

    Vizcaya

Other trials in Spain

About this study

Official title: 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.

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
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01504529
Study groupRoleWhat they receive
Neupro TreatmentData 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline to Month 6 in Non-Motor Symptoms (NMS) as assessed by the Parkinson's Disease Non-Motor Symptoms Questionnaire (PDNMS-Q)

    Measured: From Baseline to Month 6

Secondary outcomes (2)

  1. Change from Baseline to Month 6 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III

    Measured: From Baseline to Month 6

  2. Change from Baseline to Month 6 in Hoehn & Yahr stage

    Measured: From Baseline to Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2012 (estimated)
  2. Study startSep 2011
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
391 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01504529
Sponsor's protocol ID
SP1018
Other IDs
UCB-ROT-2011-01
Acronym
RETO-PD
Status last verified
Apr 2013
First submitted
3 Jan 2012
Last updated
15 Apr 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 29249180

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson's Disease, run by UCB Pharma at 59 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: From Baseline to Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01504529, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2013.

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