Transdermal Rotigotine User Surveillance Study (TRUST)
This study is ongoing, but not recruiting participants.
Sponsor:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00599339
First received: January 10, 2008
Last updated: May 21, 2013
Last verified: May 2013
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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
Show 211 Study LocationsSponsors 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: | May 21, 2013 |
| 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 May 23, 2013