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

This study has been completed.
Sponsor:
Collaborator:
Pivotal S.L.
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01504529
First received: January 3, 2012
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

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.


Condition
Parkinson's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Non-Interventional, Retrospective, Multi-center Study to Evaluate Non-Motor Symptoms in Advanced PD Patients Already Treated With Rotigotine

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline to Month 6 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III [ Time Frame: From Baseline to Month 6 ] [ Designated as safety issue: No ]
  • Change from Baseline to Month 6 in Hoehn & Yahr stage [ Time Frame: From Baseline to Month 6 ] [ Designated as safety issue: No ]

Enrollment: 391
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504529

  Show 59 Study Locations
Sponsors and Collaborators
UCB Pharma
Pivotal S.L.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01504529     History of Changes
Other Study ID Numbers: SP1018, UCB-ROT-2011-01
Study First Received: January 3, 2012
Last Updated: April 12, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by UCB Pharma:
Rotigotine (Neupro)
Non-Motor Symptoms
Advanced Parkinson's Disease
Local study
Spain
Observational study
Non-interventional study
Retrospective study
Post-marketing study
Multicenter study

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
N 0437
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014