Transdermal Rotigotine User Surveillance Study (TRUST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00599339
First received: January 10, 2008
Last updated: October 17, 2014
Last verified: April 2014
  Purpose

This study will be conducted in an observational multiple-cohort design aimed at acquiring clinical, treatment, health status, and economic data. Patients with Parkinson's disease (PD) will be enrolled.


Condition
Idiopathic Parkinson Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Naturalistic, Multisite, Observational Study of Rotigotine Transdermal Patch and Other Currently Prescribed Therapies in Patients With Idiopathic Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Change from Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) part III [ Time Frame: 33 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) question 32 of part IV [ Time Frame: 33 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) question 33 of part IV [ Time Frame: 33 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) question 39 of part IV [ Time Frame: 33 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Nocturnal Dystonia Cramp Score (NADCS) [ Time Frame: 33 months ] [ Designated as safety issue: No ]
  • Change from Baseline in Hoehn & Yahr stage [ Time Frame: 33 months ] [ Designated as safety issue: No ]
  • Reported adverse events of cardiac valve fibrosis [ Time Frame: 33 months ] [ Designated as safety issue: Yes ]

Enrollment: 2197
Study Start Date: June 2006
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Neupro
Neupro at study onset
Dopamine Agonist
Other Dopamine-Agonist at study onset
L-Dopa
L-Dopa
Neupro + L-Dopa
Neupro in combination with L-Dopa at study onset
Dopamine Agonist + L-Dopa
Other Dopamine Agonist in combination with L-Dopa at study onset

Detailed Description:

All patients attending the physician and fulfilling the eligibility criteria are included.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary Care

Criteria

Inclusion Criteria:

  • Patients with idiopathic early-stage Parkinson's Disease requiring dopaminergic monotherapy (rotigotine, other dopamine agonists or levodopa) at study onset
  • Patients with advanced-stage Parkinson's Disease requiring dopaminergic therapy with levodopa in combination with rotigotine or other dopamine agonists at study onset

Exclusion Criteria:

  • Patients who are unable to comply with study requirements
  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: NCT00599339

  Show 211 Study Locations
Sponsors and Collaborators
UCB Pharma
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: NCT00599339     History of Changes
Other Study ID Numbers: SP0854
Study First Received: January 10, 2008
Last Updated: October 17, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
Czech Republic: State Institute for Drug Control
Italy: The Italian Medicines Agency
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
Switzerland: Swissmedic
Greece: National Organization of Medicines
Denmark: Danish Medicines Agency
Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by UCB Pharma:
Rotigotine
Neupro

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 October 19, 2014