Trial record 12 of 26 for:    Neuroleptic Malignant Syndrome

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, Inc.
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, Inc.:

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

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

No publications provided

Responsible Party: UCB, Inc.
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, Inc.:
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
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
N 0437
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014