Transdermal Rotigotine User Surveillance Study (TRUST)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00599339
First received: January 10, 2008
Last updated: March 11, 2014
Last verified: March 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, Inc.:

Primary Outcome Measures:
  • Change from baseline in UPDRS part III [ Time Frame: 33 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in UPDRS question 32 of part IV [ Time Frame: 33 months ] [ Designated as safety issue: No ]
  • Change from baseline in UPDRS question 33 of part IV [ Time Frame: 33 months ] [ Designated as safety issue: No ]
  • Change from baseline in 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
Estimated Study Completion Date: April 2014
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00599339

  Show 211 Study Locations
Sponsors and Collaborators
UCB, Inc.
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: NCT00599339     History of Changes
Other Study ID Numbers: SP854
Study First Received: January 10, 2008
Last Updated: March 11, 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, Inc.:
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 April 17, 2014