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NCT Number: NCT01504529

Non-interventional, Retrospective, Multi-center Study to Evaluate Non-motor Symptoms in Advanced Parkinson Disease (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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

65, A Coruña, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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)

    Time frame: From Baseline to Month 6

Secondary outcomes

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

    Time frame: From Baseline to Month 6

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

    Time frame: From Baseline to Month 6

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Collaborators

  • Pivotal S.L.

Registry information

Official study title

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

Acronym: RETO-PD

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 5, 2012
Registry last updated
Apr 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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